Home › NDC Lookup › Ingredients › Diclofenac Sodium, Isopropyl Alcohol › 59088-0709-00

VennGel One diclofenac sodium, isopropyl alcohol Kit

by PureTek Corporation · 1 KIT in 1 PACKAGE (59088-709-00) * 1 TUBE in 1 CARTON (65162-833-66) / 100 g in 1 TUBE

NDC 59088-0709-00

🏷️ FDA NDC (as labeled) 59088-709-00 billing pads the product segment with a zero

Rx only On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59088-709-00

Product NDC 59088-709

11-digit billing NDC 59088070900

NCPDP billing unit EA — each (per item)

RxCUI 855633

SPL Set ID e0979152-132e-466b-8b56-87826f190c89

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-05-02

Dosage form KIT

GPI-14 90210030306440

GPI class VennGel One

GCN Seq No 076654

GCN 42358

HICL code 003733

Ingredient (HICL) Diclofenac Sodium

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q5E

Therapeutic class — specific (HIC3) Topical Anti-Inflammatory, Nsaids

AHFS code 28:08.04.04

AHFS class Reversible Cox-1/Cox-2 Inhibitors

FDB label name VENNGEL ONE 1% KIT

FDB brand name Venngel One

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 59088-709-00 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59088-0709-00. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug

Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use

How it works Cyclooxygenase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPureTek Corporation

Labeler code59088

First marketedMay 2018

Product typeHuman Prescription Drug

Portfolio178 products on file

🔎 All NDCs from PureTek Corporation

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name VENNGEL ONE 1% KIT Ingredient Diclofenac Sodium

📖 What it is MedlinePlus · NLM

Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph e...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

This gel is specifically approved for osteoarthritis pain — the kind that comes from joint wear and tear over time. It works best on joints close to the skin's surface, like your k...
What exactly is this gel for — can I use it for any joint pain?
There's a dosing card in the box — use it every time to measure the right amount. Don't just squeeze from the tube and guess. Once you have the right amount on the card, use your h...
How do I actually apply it — do I just squeeze some out?

📖 Read our full Diclofenac Topical (arthritis pain) guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

From the label’s inactive-ingredient sectionWater

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$2,730.75	—
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
good sense arthritis pain 10 mg/g 00113-1189-01	L.	1 tube	$0.083	—	Availability likely	—
Good Sense Arthritis Pain 10 mg/g 00113-8175-01	L.	1 tube	$0.083	—	Availability likely	—
Diclofenac Sodium 10 mg/g 45802-0953-01	Padagis	1 tube	$0.083	—	Availability likely	—
Diclofenac Sodium 10 mg/g 68001-0621-45	BluePoint	1 tube	$0.083	—	Availability likely	—
Diclofenac sodium 10 mg/g 69097-0720-44	Cipla	1 tube	$0.083	—	Availability likely	—
Diclofenac sodium 10 mg/g 69238-2053-01	Amneal	1 tube	$0.083	—	Availability likely	—
Diclofenac Sodium 10 mg/g 70512-0106-10	SOLA	1 tube	$0.083	—	Availability likely	—
Arthritis Pain 10 mg/g 70677-1125-01	Strategic	1 tube	$0.083	—	Availability likely	—
Foster And Thrive Arthritis Pain 10 mg/g 70677-1293-01	Strategic	1 tube	$0.083	—	Availability likely	—
Diclofenac Sodium 10 mg/g 76282-0103-39	EXELAN	1 tube	$0.083	—	Availability likely	—
Arthritis Pain Reliever 10 mg/g 83324-0306-01	QUALITY	1 tube	$0.083	—	Availability likely	—
Arthritis Pain Reliever 10 mg/g 46122-0752-37	AmerisourceBergen	1 tube	$0.123	—	Availability likely	—
Diclofenac sodium 10 mg/g 70000-0555-01	CARDINAL	1 tube	$0.123	—	Availability likely	—
Voltaren Arthritis Pain 10 mg/g 00067-8152-01	Haleon	1 tube	—	—	FDA listed	—
Voltaren Arthritis Pain 00067-8153-01	Haleon	1 kit	—	—	FDA listed	—
Voltaren Arthritis Pain 00067-8154-01	Haleon	1 kit	—	—	FDA listed	—
Aleve Arthritis Pain Gel 1 mg/g 00280-0039-01	Bayer	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 00363-1210-17	Walgreens	1 tube	—	—	FDA listed	—
Arthritis Pain Relieving 10 mg/g 00363-3003-02	Walgreen	1 tube	—	—	FDA listed	—
arthritis pain relieving 10 mg/g 00363-5123-01	Walgreen	1 tube	—	—	Discontinued	—
Diclofenac Sodium Topical Gel 1% 10 mg/g 00363-7065-10	Walgreens	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 00536-1294-31	Rugby	1 tube	—	—	FDA listed	—
up and up arthritis pain reliever 10 mg/g 11673-0569-01	Target	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 11822-0870-01	Rite	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 21130-0028-10	Safeway,	1 tube	—	—	FDA listed	—
signature care arthritis pain 10 mg/g 21130-0313-01	Safeway	1 tube	—	—	Discontinued	—
Diclofenac Sodium 10 mg/g 21922-0044-29	Encube	1 tube	—	—	Discontinued	—
Diclofenac Sodium Topical Gel 1% 10 mg/g 30142-0025-10	Kroger	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 30142-0277-10	KROGER	1 tube	—	—	FDA listed	—
topcare athritis pain reliever 10 mg/g 36800-0526-01	Topco	1 tube	—	—	FDA listed	—
arthritis pain reliever 10 mg/g 37808-0087-01	H	1 tube	—	—	FDA listed	—
equaline arthritis pain relieving 10 mg/g 41163-0087-01	United	1 tube	—	—	FDA listed	—
Aspercreme Arthritis .01 g/g 41167-0571-00	Chattem,	1 tube	—	—	FDA listed	—
Aspercreme Arthritis .01 g/g 41167-0573-02	Chattem,	1 tube	—	—	FDA listed	—
arthritis pain relieving 10 mg/g 41250-0674-01	Meijer	1 tube	—	—	FDA listed	—
CareOne arthritis pain relief 10 mg/g 41520-0788-01	American	1 tube	—	—	FDA listed	—
arthritis pain reliever 10 mg/g 42507-0150-01	HyVee	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 43598-0885-10	Dr.	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 43598-0977-05	Dr.	1 tube	—	—	FDA listed	—
equate arthritis pain 10 mg/g 49035-0262-01	Wal-Mart	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 49035-0269-17	EQUATE	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 50090-4020-00	A-S	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 50090-4030-00	A-S	1 tube	—	—	FDA listed	—
Voltaren Arthritis Pain 10 mg/g 50090-6202-00	A-S	24 tubes	—	—	Discontinued	—
Diclofenac Sodium 10 mg/g 50090-6998-00	A-S	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 50090-7243-00	A-S	1 tube	—	—	FDA listed	—
good sense arthritis pain 10 mg/g 50090-7250-00	A-S	1 tube	—	—	FDA listed	—
Motrin Arthritis Pain 9.3 mg/g 50580-0574-01	Kenvue	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 51316-0012-15	CVS	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 51316-0073-76	CVS	1 tube	—	—	FDA listed	—
Diclofenac Sodium Topical 10 mg/g 51316-0804-01	CVS	1 tube	—	—	FDA listed	—
Arthritis Pain 10 mg/g 53943-0523-01	Discount	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 55319-0969-17	Family	1 tube	—	—	FDA listed	—
Salonpas 10 mg/g 55328-0801-10	Hisamitsu	1 tube	—	—	FDA listed	—
DG health arthritis pain 10 mg/g 55910-0424-02	Dolgencorp	1 tube	—	—	FDA listed	—
Dg Health Arthritis Pain 10 mg/g 55910-0926-50	Dolgencorp	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 56062-0471-02	Publix	1 tube	—	—	FDA listed	—
arthritis pain reliever 10 mg/g 56062-0878-01	Publix	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 57483-0185-11	INNOVUS	1 tube	—	—	FDA listed	—
Crcle Diclofenac Sodium Topical Gel 1% 10 mg/g 57483-0596-01	Innovus	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 57896-0140-01	GERI-CARE	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 57896-0147-01	GERI-CARE	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 58602-0604-07	Aurohealth	1 tube	—	—	FDA listed	—
Diclofenac Sodium 58602-0606-21	Aurohealth	1 kit	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 58602-0609-07	Aurohealth	1 tube	—	—	FDA listed	—
VennGel Onethis 59088-0709-00	PureTek	1 kit	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 59640-0198-01	H	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 59726-0012-50	P	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 62379-0401-02	Simple	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 63187-0753-00	Proficient	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 63868-0730-01	Chain	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 63941-0812-53	Best	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 63981-0112-15	Costco	3 tubes	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 63981-0211-15	Costco	3 tubes	—	—	FDA listed	—
kirkland signature arthritis pain relief 10 mg/g 63981-0599-05	Costco	3 tubes	—	—	FDA listed	—
kirkland signature arthritis pain relief 10 mg/g 63981-0799-05	Costco	3 tubes	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 67296-2155-01	Redpharm	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 68016-0171-00	Chain	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 68071-2239-01	NuCare	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 68071-3456-01	NuCare	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 68071-3665-01	NuCare	1 tube	—	—	FDA listed	—
diclofenac sodium 10 mg/g 68071-3671-01	NuCare	1 tube	—	—	FDA listed	—
Members Mark Arthritis Pain Reliever 10 mg/g 68196-0523-05	Sam's	3 tubes	—	—	FDA listed	—
members mark arthritis pain reliever 10 mg/g 68196-0870-05	Sam's	3 tubes	—	—	FDA listed	—
berkley and jensen arthritis pain 68391-0205-00	BJWC	1 kit	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 68788-7772-01	Preferred	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 69842-0729-01	CVS	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 69842-0974-06	CVS	2 tubes	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 71205-0552-00	Proficient	1 tube	—	—	FDA listed	—
good sense arthritis pain 10 mg/g 71205-0670-00	Proficient	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 71205-0747-00	Proficient	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 72036-0014-10	Harris	1 tube	—	—	FDA listed	—
Gencare-Arthritis Pain Relief .01 g/g 72090-0017-01	Pioneer	1 tube	—	—	FDA listed	—
Diclofenac Sodium Gel 10 mg/g 72189-0479-01	Direct_Rx	1 g	—	—	FDA listed	—
Amazon Basic Care Arthritis Pain 10 mg/g 72288-0624-03	Amazon.com	1 tube	—	—	FDA listed	—
basic care arthritis pain 10 mg/g 72288-0870-01	Amazon.com	1 tube	—	—	FDA listed	—
Arthritis Pain Reliever 10 mg/g 72476-0212-17	Care	1 tube	—	—	Discontinued	—
Curist Arthritis Relief 1 g/100g 72559-0020-24	Little	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 73469-2053-01	Scholl's	1 tube	—	—	FDA listed	—
Diclofenac Sodium Topical 1% 1 mg/100g 73581-0104-15	YYBA	1 tube	—	—	FDA listed	—
Diclofenac Sodium Topical Gel, 1% 1 g/100g 73715-0005-01	Mohnark	50 g	—	—	Discontinued	—
Topcare Arthritis Pain Reliever 10 mg/g 76162-0804-01	Topco	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 76420-0091-01	Asclemed	100 g	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 76420-0691-01	Asclemed	1 tube	—	—	FDA listed	—
Arthritis Pain Relieving 10 mg/g 79481-0499-00	Meijer,	1 tube	—	—	FDA listed	—
Equate Arthritis Pain 10 mg/g 79903-0391-01	WALMART	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 80425-0233-01	Advanced	1 tube	—	—	FDA listed	—
Up And Up Arthritis Pain Reliever 10 mg/g 82442-0251-01	Target	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 83008-0037-00	Quality	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 84386-0120-01	Aurobindo	1 tube	—	—	FDA listed	—
Diclofenac sodium 10 mg/g 85766-0136-01	Sportpharm	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 85766-0137-01	Sportpharm	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 85766-0160-01	Sportpharm	1 tube	—	—	FDA listed	—
VennGel II 59088-0224-00	PureTek	1 kit	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2018

On the market since

May 2018

📍

2026

Currently FDA-listed

8 years listed

🔒

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59088-0709-00, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q2 2025 · 2 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

285

Units reimbursed last 4 qtrs

285

Gross reimbursed last 4 qtrs

$778.3K

Avg / prescription

$2,730.75

Avg / unit

$2,730.75

Latest quarter Q2 2025

139Rx

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 285 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

7.97.9

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Connecticut 7.9 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VennGel One (this brand).

Top reported reactions

Colon Cancer Stage Iii1

Colorectal Cancer1

Reporter sex

Female · 100%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
59088-0709-00 You're viewing this	1 KIT in 1 PACKAGE (59088-709-00) * 1 TUBE in 1 CARTON (65162-833-66) / 100 g in 1 TUBE	2018-05-02	Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~1 min read ▾

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK FULL PRESCRIBING INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ] . Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4 ) and Warnings and Precautions (5.1) ] .

Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions (5.2) ] .

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.1 ) Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

( 5.2 )

🎯 Indications and Usage 122 words ▾

1 INDICATIONS AND USAGE Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel, 1% is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

( 1 ) Diclofenac sodium topical gel, 1% was not evaluated for use on joints of the spine, hip, or shoulder. ( 14.1 )

Uses Antiseptic cleanser Kills harmful bacteria and germs First aid help prevent infection

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) Lower extremities: Apply the gel (4 g) to the affected area 4 times daily. Do not apply more than 16 g daily to any one affected joint of the lower extremities.

( 2.2 ) Upper extremities: Apply the gel (2 g) to the affected area 4 times daily. Do not apply more than 8 g daily to any one affected joint of the upper extremities. ( 2.3 ) Total dose should not exceed 32 g per day, over all affected joints.

( 2.3 ) Diclofenac sodium topical gel should be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. ( 2 )

2.1Dosing Card [See the patient Instructions for Use] The dosing card can be found attached to the inside of the carton. The proper amount of diclofenac sodium topical gel, 1% should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene.

The dosing card should be used for each application of drug product. The gel should be applied within the rectangular area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long.

The 4 g line is 4.5 inches long. The dosing card containing diclofenac sodium topical gel, 1% can be used to apply the gel. The hands should then be used to gently rub the gel into the skin.

After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.

2.2Lower extremities including the feet, ankles, or knees Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily. Diclofenac sodium topical gel, 1% should be gently massaged into the skin ensuring application to the entire affected foot, or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.

2.3Upper extremities including the hands, wrists, or elbows Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily. Diclofenac sodium topical gel, 1% should be gently massaged into the skin ensuring application to the entire affected hand, wrist, or elbow. The entire hand includes the palm, back of the hands, and the fingers.

Do not apply more than 8 g daily to any single joint of the upper extremities. Total dose should not exceed 32 g per day, over all affected joints.

2.4Special Precautions Avoid showering/bathing for at least 1 hour after the application. Inform patient to wash his/her hands after use, unless the hands are the treated joint. If diclofenac sodium topical gel, 1% is applied to the hand(s) for treatment; inform patient not to wash the treated hand(s) for at least 1 hour after the application.

Do not apply diclofenac sodium topical gel, 1% to open wounds. Avoid contact of diclofenac sodium topical gel, 1% with eyes and mucous membranes. Do not apply external heat and/or occlusive dressings to treated joints.

Avoid exposure of the treated joint(s) to natural or artificial sunlight. Avoid concomitant use of diclofenac sodium topical gel, 1% on the treated skin site with other topical products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications Concomitant use of diclofenac sodium topical gel, 1% with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects. Do not use combination therapy with diclofenac sodium topical gel, 1% and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

Avoid wearing of clothing or gloves for at least 10 minutes after applying diclofenac sodium topical gel, 1%.

Di…

💊 Dosage Forms and Strengths 16 words ▾

3 DOSAGE FORM AND STRENGTH Diclofenac sodium topical gel, 1% Diclofenac sodium topical gel, 1% (3)

⛔ Contraindications 135 words ▾

4 CONTRAINDICATIONS Diclofenac sodium topical gel is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 )] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 )] Known hypersensitivity to diclofenac orany components of the drug product.

( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4 ) In the setting of CABG surgery. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema: Avoid use of diclofenac sodium topical gel in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Avoid use of diclofenac sodium topical gel in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac sodium topical gel is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) Serious Skin Reactions: Discontinue diclofenac sodium topical gel at first appearance of rash or other signs of hypersensitivity ( 5.9 ) Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.

( 5.10 , 8.1 ) Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.11 , 7 )

5.1Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events [ see Warnings and Precautions (5.2) ]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG [ see Contraindications (4) ]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated…

⚠️ Warnings 84 words ▾

Warnings For External Use Only Avoid contact with the eyes. If contact occurs, flush eyes with water Flammable, keep away from fire or flame. Do not use With electrocautery procedures In the eyes Stop use and ask a doctor if Irritation and redness develops If condition persists for more than 72 hours, consult a physician Discontinue use and consult a healthcare practitioner if Irritation develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2) ] Hepatotoxicity [ see Warnings and Precautions (5.3) ] Hypertension [ see Warnings and Precautions (5.4) ] Heart Failure and Edema [ see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ] Anaphylactic Reactions [ see Warnings and Precautions (5.7) ] Serious Skin Reactions [ see Warnings and Precautions (5.9) ] Hematologic Toxicity [ see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence >2% of patients treated with diclofenac sodium topical gel and greater than placebo) are application site reactions, including dermatitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development, 913 patients were exposed to diclofenac sodium topical gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities.

Of these, 513 patients received diclofenac sodium topical gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to diclofenac sodium topical gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees.

Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial. Short-Term Placebo-Controlled Trials: Adverse reactions observed in at least 1% of patients treated with diclofenac sodium topical gel: Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing diclofenac sodium topical gel and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. These were the only adverse reactions that occurred in > 1% of treated patients with a greater frequency in the diclofenac sodium topical gel group (7%) than the placebo group (2%).

Table 1 lists the types of application site reactions reported. Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with diclofenac sodium topical gel, compared to 1% of placebo patients. Adverse Reaction † Diclofenac sodium topical gel N=913 Placebo (vehicle) N=876 N (%) N (%) Any application site reaction 62 (7) 19 (2) Application site dermatitis 32 (4) 6 (˂1) Application site pruritus 7 (˂1) 1 (˂1) Application site erythema 6 (˂1) 3 (˂1) Application site paresthesia 5 (˂1) 3 (˂1) Application site dryness 4 (˂1) 3 (˂1) Application site vesicles 3 (˂1) 0 Application site irritation 2 (˂1) 0 Application site papules 1 (˂1) 0 † Preferred Term according to MedDRA

9.1In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with diclofenac sodium topical gel, and 3% for patients in the placebo group. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation. Long-Term Open-Label Safety Trial: In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies.

In this study, where patients were treated for up to 1 year with diclofenac sodium…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac sodium topical gel with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions (5.11) ].

Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and Precautions (5.2) ]. Intervention: Concomitant use of diclofenac sodium topical gel and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions (5.11) ].

Diclofenac sodium topical gel is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol) In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. Intervention: During concomitant use of diclofenac sodium topical gel and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of diclofenac sodium topical gel and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions (5.6)].

When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of diclofenac sodium topical gel with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Warnings and Precautions (5.6) ]. Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Intervention: During concomitant use of diclofenac sodium topical gel and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation ( 5.10 , 8.1 ) Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of diclofenac sodium topical gel in women who have difficulties conceiving. ( 8.3 )

8.1Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women.

Human and animal studies indicate that diclofenac crosses the placenta. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss.

In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 5, 5, and 10 times, respectively, the maximum recommended topical dose of diclofenac sodium topical gel, despite the presence of maternal and fetal toxicity at these doses [see Data] . Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. Clinical Considerations Labor or Delivery There are no studies on the effects of diclofenac sodium topical gel during labor or delivery. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Data Animal data Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose (MRHD) of diclofenac sodium topical gel based on bioavailability and body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 5 and 10 times the MRHD based on bioavailability and BSA comparison).

In a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (approximately 1 and 2 times the MRHD based on bioavailability and BSA comparison) from Gestation Day 15 through Lactation Day 21, significant maternal toxicity (peritonitis, mortality) was noted. These maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.

8.2Lactation Risk Summary Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CATAFLAM and any potential adverse effects on the breastfed infant from the CATAFLAM or from the underlying maternal condition. Data One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day.

Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in th…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 187 words ▾

8.5Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.6 , 5.13 ) ]. Of the total number of subjects treated with diclofenac sodium topical gel in clinical studies, 498 were 65 years of age and over.

No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity to the effect of NSAIDs in some older individuals cannot be ruled out. Diclofenac, as with any NSAID, is known to be substantially excreted by the kidney, and the risk of toxic reactions to diclofenac sodium topical gel may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when using diclofenac sodium topical gel in the elderly, and it may be useful to monitor renal function.

🆘 Overdosage 111 words ▾

10 OVERDOSAGE There has been no experience of overdose with diclofenac sodium topical gel. Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred.

Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions (5.1, 5.2, 5.4, 5.6) ]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes.

Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdose treatment, call a Poison Control Center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium topical gel, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro.

Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. 12.3 Pharmacokinetics The pharmacokinetics of diclofenac sodium topical gel were assessed in healthy volunteers following repeated applications during 7 days of diclofenac sodium topical gel to 1 knee (4 x 4 g per day) or to 2 knees and 2 hands (4 x 12 g per day) versus the recommended oral dose of diclofenac sodium for the treatment of osteoarthritis (3 x 50 mg per day).

A summary of the pharmacokinetic parameters is presented in Table 2. Table 3. Pharmacokinetic Parameters and Comparison of Diclofenac Sodium Topical Gel to Oral Diclofenac Sodium Tablets After Repeated Administration Treatment C max (ng/mL) Mean ± SD % of Oral (CI) t max (hr) Median (range) AUC 0-24 (ng●h/mL) Mean ± SD % of Oral (CI) Diclofenac sodium topical gel 4 x 4 g per day (= 160 mg diclofenac sodium per day) 15 ± 7.3 0.6% (0.5 to 0.7) 14 (0 to 24) 223 ± 128 5.8% (5 to 6.7) Diclofenac sodium topical gel 4 x 12 g per day (= 480 mg diclofenac sodium per day) 53.8 ± 32 2.2% (1.9 to 2.6) 10 (0 to 24) 807 ± 478 19.7% (17 to 22.8) Diclofenac sodium tablets, orally 3 x 50 mg per day (=150 mg diclofenac sodium per day) 2270 ± 778 100% 6.5 (1 to 14) 3890 ± 1710 100% C max = maximum plasma concentration, t max = time of C max : AUC 024 = area under the concentration-time curve; SD = standard deviation; CI confidence interval.

Systemic exposure (area under the concentration-time curve) and maximum plasma concentrations of diclofenac are significantly lower with diclofenac sodium topical gel than with comparable oral treatment of diclofenac sodium. Systemic exposure with recommended use of diclofenac sodium topical gel (4 x 4 g per day applied to 1 knee) is on average 17 times lower than with oral treatment. (Basis: treatment with diclofenac sodium topical gel of 1 knee, 4 times a day versus 50 mg, 3 times a day of oral diclofenac tablets.) The amount of diclofenac sodium that is systemically absorbed from diclofenac sodium topical gel is on average 6% of the systemic exposure from an oral form of diclofenac sodium.

The average peak plasma concentration with recommended use of diclofenac sodium topical gel (4 x 4 g per day applied to 1 knee) is 158 times lower than with the oral treatment. The pharmacokinetics of diclofenac sodium topical gel has been tested under conditions of moderate heat (application of a heat patch for 15 minutes prior to gel application) and of moderate exercise (first gel application followed by a 20-minute treadmill exercise). No clinically relevant differences of systemic absorption and of tolerability were found between applications of diclofenac sodium topical gel (4 x 4 g per day on 1 knee) with and under the conditions tested.

However, the pharmacokinetics of diclofenac sodium topical gel were not tested under the condition of heat application following gel application. Therefore, concurrent use of diclofenac sodium topical gel and heat is not recommended. Drug Interaction Studies Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered.

The clinical significance of this interaction is not known. See Table 2 for clinically significant drug interactions of NSAIDs with aspirin [ see Drug Interactions (…

🧬 Mechanism of Action 101 words ▾

Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

📦 How Supplied / Storage and Handling 85 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac sodium topical gel, 1% is available in tubes containing 100 g of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 g tube NDC 65162-833-66 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep from freezing. Store the dosing card with your diclofenac sodium topical gel.

📦 Storage and Handling 11 words ▾

Other Information Store at room temperature 15°-30°C (59°-86°F) Avoid excessive heat

🧪 Active Ingredient 8 words ▾

Active ingredient Isopropyl Alcohol, 70% v/v Purpose Antiseptic

🧪 Inactive Ingredients 3 words ▾

Inactive Ingredients Water

🎯 Purpose 2 words ▾

Purpose Antiseptic

📋 Description 116 words ▾

11 DESCRIPTION Diclofenac sodium topical gel, 1% w/w is a non-steroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, USP, in an opaque, white to off-white gel base. Diclofenac sodium, USP is a white to off-white crystalline powder.

Diclofenac sodium, USP is a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.13.

Its molecular formula is C 14 H 10 Cl 2 NNaO 2 . It has the following structural formula: Diclofenac sodium topical gel, 1% also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution. chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with diclofenac sodium topical gel, 1% and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions (5.1) ].

Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions (5.2) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms).

If these occur, instruct patient to stop diclofenac sodium topical gel and seek immediate medical therapy [ see Warnings and Precautions (5.3) ]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions (5.5) ]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).

Instruct patients to seek immediate emergency help if these occur [ see Contraindications (4) and Warnings and Precautions (5.7) ]. Serious Skin Reactions Advise patients to stop diclofenac sodium topical gel immediately if they develop any type of rash and contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9) ]. Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium topical gel, may be associated with a reversible delay in ovulation [ see Use in Specific Populations (8.3) ] Fetal Toxicity Inform pregnant women to avoid use of diclofenac sodium topical gel and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [ see Warnings and Precautions (5.10) and Use in Specific Populations (8.1) ].

Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of diclofenac sodium topical gel with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions (5. 2) and Drug Interactions (7) ]. Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia.

Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with diclofenac sodium topical gel until they talk to their healthcare provider [ see Drug Interactions (7) ]. Eye Exposure Instruct patients to avoid contact of diclofenac sodium topical gel with the eyes and mucosa, although not studied, should be avoided. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour [ see Warnings and Precautions (5.15) ].

Special Application Instructions Instruct patients how to use the dosing card to measure the proper dose of diclofenac sodium topical gel to apply. If the patient loses their dosing card, instruct them that they can call 1-800-398-…

💬 Medication Guide ~3 min read ▾

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol oolder age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDS: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.

Before taking NSAIDs, tell your health care provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Talk to your health care provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. are breastfeeding or plan to breast feed.

Tell your health care provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking new medicine without talking to your health care provider first.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” ·new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting and dizziness.

Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop taking your NSAID and call your health care provider right away if you get any of the following symptoms: ·nausea more tired or weaker than usual diarrhea itching your skin or eyes look yellow indigestion or stomach pain flu-like symptoms ·vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms, legs, hands, and feet If you take too much of your NSAID, call your health care provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your health care provider or pharmacist abo…

Glossary — plain-language definitions of medical terms used in this label:

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

synergistic: When two things taken together produce a larger effect than adding their separate effects would predict.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

discontinuation rate: The share of people in a study who stopped taking a treatment before the study was finished.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

fertility: The natural ability to become pregnant or to father a child.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematemesis: Vomiting blood, which may look bright red or like dark coffee grounds.

hematocrit: A blood test showing what share of your blood is made up of red blood cells.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intramuscular: An injection given deep into a muscle; often written as IM.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

synergistic effect: When two medicines taken together produce a combined effect that is greater than simply adding their separate effects.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 59088-0700-01 · PureTek 59088-0712-00 · PureTek →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

VennGel One diclofenac sodium, isopropyl alcohol Kit

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