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Diclofenac Sodium 10 mg/g Gel — NDC 68071-3665-1 (Billing 68071-3665-01)

by NuCare Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Diclofenac Sodium 10 mg/g Gel from NuCare Pharmaceuticals, Inc., marketed since Aug 2018 and currently FDA-listed. It is this product's only package size.

NDC 68071-3665-01
🏷️ FDA NDC (as labeled) 68071-3665-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

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

⚠️
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 27, 2026 — Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0342-2026
Class III · Dec 22, 2025 — Failed PH Specifications (Cipla USA, Inc.) · FDA recall D-0291-2026
Class II · Jun 22, 2023 — Defective Delivery System (ALEMBIC PHARMACEUTICALS, INC.) · FDA recall D-0941-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-3665-1
Product NDC 68071-3665
11-digit billing NDC 68071366501
RxCUI 855633
UNII QTG126297Q
UPC 0368071366518
Application # ANDA209903
SPL Set ID 200c2800-a703-e138-e063-6394a90acc09
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-16
Route TOPICAL
Dosage form GEL
Substance DICLOFENAC SODIUM
Quick answers
  • RxCUI (RxNorm): 855633
Why two NDCs? The FDA registers this code as 68071-3665-1 — a 5-4-1 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 package segment → 68071-3665-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your produ...
  • Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb,...
  • Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your docto...
  • Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new ra...
📖 Read our full Diclofenac guide →
1
Nutrient depletion considerations

Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diclofenac Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68071-3665-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2018-08-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense arthritis pain 10 mg/g 00113-1189-01 L. 1 tube $0.081 — Availability likely —
Good Sense Arthritis Pain 10 mg/g 00113-8175-01 L. 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 45802-0953-01 Padagis 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 68001-0621-45 BluePoint 1 tube $0.081 — Availability likely —
Diclofenac sodium 10 mg/g 69097-0720-44 Cipla 1 tube $0.081 — Availability likely —
Diclofenac sodium 10 mg/g 69238-2053-01 Amneal 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 70512-0106-10 SOLA 1 tube $0.081 — Availability likely —
Arthritis Pain 10 mg/g 70677-1125-01 Strategic 1 tube $0.081 — Availability likely —
Foster And Thrive Arthritis Pain 10 mg/g 70677-1293-01 Strategic 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 76282-0103-39 EXELAN 1 tube $0.081 — Availability likely —
Arthritis Pain Reliever 10 mg/g 83324-0306-01 QUALITY 1 tube $0.081 — Availability likely —
Arthritis Pain Reliever 10 mg/g 46122-0752-37 AmerisourceBergen 1 tube $0.117 — Availability likely —
Diclofenac sodium 10 mg/g 70000-0555-01 CARDINAL 1 tube $0.117 — 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 One 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 — — Discontinued —
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/gthis 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 —
Arthritis Pain Relief 10 mg/g 51316-0517-00 CVS 2 tubes — — FDA listed —
Diclofenac Sodium 10 mg/g 68788-4335-01 Preferred 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 68071-5307-01 NuCare 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68788-4135-01 Preferred 1 tube — — FDA listed —
Diclofenac 10 mg/g 73581-0410-01 YYBA 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 11673-0028-10 Target 1 tube — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Aug 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerNuCare Pharmaceuticals, Inc.
Application holderCIPLA LTD
FDA applicationANDA209903 (ANDA)
Labeler code68071
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio365 products on file
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

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 ) 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 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 ) ].

🎯 Indications and Usage 103 words ▾

1 INDICATIONS AND USAGE Diclofenac sodium 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 was not evaluated for use on joints of the spine, hip, or shoulder. ( 14.1 ) Diclofenac sodium topical gel 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 has not been evaluated for use on the spine, hip, or shoulder.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 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 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ].

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 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 4g 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 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 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 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 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 to open wounds. Avoid contact of diclofenac sodium topical gel 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 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 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 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.

💊 Dosage Forms and Strengths 18 words ▾

3 DOSAGE FORMS AND STRENGTHS Diclofenac sodium topical gel, 1%, ( 3 ) Diclofenac sodium topical gel, 1%

⛔ Contraindications 133 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to diclofenac or any 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 ) Diclofenac sodium 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 ) ]

⚠️ 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 10-14 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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence >2% of patients treated with diclofenac sodium and greater than placebo) are application site reactions, including dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 ) ]

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. Table 1.

Non-serious Application Site Adverse Reactions (≥1% Diclofenac Sodium Patients) –Short-term Controlled Trials † Preferred Term according to MedDRA 9.1. Diclofenac sodium topical gel Placebo (vehicle) N=913 N=876 Adverse Reaction † 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 In 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 i… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs) : Monitor patients for bleeding who are concomitantly using diclofenac sodium topical gel with drugs that interfere with hemostasis. Concomitant use of diclofenac sodium topical gel and analgesic doses of aspirin is not generally recommended ( 7 ) ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers : Concomitant use with diclofenac sodium topical gel may diminish the antihypertensive effect of these drugs.

Monitor blood pressure ( 7 ) ACE Inhibitors and ARBs : Concomitant use with diclofenac sodium topical gel in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function ( 7 ) Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects ( 7 ) Digoxin : Concomitant use with diclofenac sodium topical gel can increase serum concentration and prolong half-life of digoxin.

Monitor serum digoxin levels ( 7 ) 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 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 and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions ( 5.11 ) ] .

Diclofenac sodium 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 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 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 trea… [Excerpted — this section continues on DailyMed.]

👥 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, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium 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 2-4% for major malformations, and 15-20% 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 , 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 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 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 the immediate postpartum period).

8.3Females and Males of Reproductive Poten… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including diclofenac sodium, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium 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 2-4% for major malformations, and 15-20% 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 , 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 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 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.

🧒 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 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 105 words ▾

10 OVERDOSAGE 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 overdosage treatment, contact 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, 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.

12.3Pharmacokinetics The pharmacokinetics of diclofenac sodium 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 C max = maximum plasma concentration, t max =time of C max . AUC 0-24 =area under the concentration time curve. SD=standard deviation.

CI=confidence interval. Treatment C max (ng/mL) T max (hr) AUC 0-24 (ng●h/mL) Mean ± SD Median Mean ± SD % of Oral (CI) Range % of Oral (CI) Diclofenac sodium topical gel 233 ± 128 4 x 4 g per day 15 ± 7.3 14 (0-24) 5.8% (=160 mg diclofenac sodium per day) 0.6% (0.5-0.7) (5-6.7) Diclofenac sodium topical gel 53.8 ± 32 10 (0-24) 807 ± 478 4 x 12 g per day 2.2% 19.7% (=480 mg diclofenac sodium per day) (1.9-2.6) (17-22.8) Diclofenac sodium tablets, orally 3 x 50 mg per day 2270 ± 778 6.5 (1-14) 3890 ± 1710 (=150 mg diclofenac sodium per day) 100% 100% 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 was 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 ( 7 ) ].

🧬 Mechanism of Action 99 words ▾

12.1Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium, 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.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac sodium topical gel, 1% is a white opaque gel available in aluminium tubes with polypropylene cap containing 100 grams of the topical gel. Each tube contains diclofenac sodium, USP in a gel base 100 grams tube………………………………NDC 68071-3665-1 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep from freezing.

Store the dosing card with your diclofenac sodium topical gel.

📋 Description 113 words ▾

11 DESCRIPTION Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene-acetic acid, monosodium salt. The molecular weight is 318.14.

Its molecular formula is C 14 H 10 Cl 2 NNaO 2 , and it has the following chemical structure: It contains the active ingredient, diclofenac sodium, USP in an opaque, white gel base. Diclofenac sodium, USP is a white to off-white, amorphous, crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative.

The inactive ingredients in diclofenac sodium topical gel include: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution. Image

💬 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 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 patients 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 to 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, 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 gelwith 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 ca… [Excerpted — this section continues on DailyMed.]

💬 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 older 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 about… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of diclofenac sodium 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 C max = maximum plasma concentration, t max =time of C max . AUC 0-24 =area under the concentration time curve. SD=standard deviation.

CI=confidence interval. Treatment C max (ng/mL) T max (hr) AUC 0-24 (ng●h/mL) Mean ± SD Median Mean ± SD % of Oral (CI) Range % of Oral (CI) Diclofenac sodium topical gel 233 ± 128 4 x 4 g per day 15 ± 7.3 14 (0-24) 5.8% (=160 mg diclofenac sodium per day) 0.6% (0.5-0.7) (5-6.7) Diclofenac sodium topical gel 53.8 ± 32 10 (0-24) 807 ± 478 4 x 12 g per day 2.2% 19.7% (=480 mg diclofenac sodium per day) (1.9-2.6) (17-22.8) Diclofenac sodium tablets, orally 3 x 50 mg per day 2270 ± 778 6.5 (1-14) 3890 ± 1710 (=150 mg diclofenac sodium per day) 100% 100% 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 was 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 ( 7 ) ].

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Pivotal Studies in Osteoarthritis of the Superficial Joints of the Extremities Study 1 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis of the knee in a 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial. Diclofenac sodium topical gel was administered at a dose of 4 g, 4 times daily, on 1 knee (16 g per day). Pain as assessed by the patients at Week 12 using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Pain Subindex was lower in the diclofenac sodium topical gel group than the placebo group.

Study 2 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis in subjects with osteoarthritis of the hand in an 8-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group study. Diclofenac sodium topical gel was administered at a dose of 2 g per hand, 4 times daily, on both hands (16 g per day). Pain in the target hand as assessed by the patients at Weeks 4 and 6 on a visual analog scale from 0 to 100 was lower in the diclofenac sodium topical gel group than the placebo group.

Table 4. Efficacy outcomes of Diclofenac sodium in Studies 1 and 2 * WOMAC = Western Ontario McMaster Osteoarthritis Index. # Scale from 0 (best) to 100 (worst). † Difference is adjusted using an analysis of covariance (ANCOVA) model with main effects of treatment and center and baseline covariate. ‡ Difference is adjusted using an analysis of covariance (ANCOVA) model with main effects of treatment, center, indicator of pain in the CMC-1joint, and baseline as a covariate, and the treatment-by-CMC-1 strata. Diclofenac sodium Placebo Adjusted Difference topical gel (Vehicle) (Placebo –Diclofenac sodium topical gel) Study 1 (Knee) Sample Size 127 119 WOMAC Pain Mean Outcome 28 37 Δ=7† *# at Week 12 95% Confidence Interval (1, 12) Study 2 (Hand) Sample Size 198 187 Pain Intensity# Mean Outcome 43 50 Δ=7‡ at Week 4 95% Confidence Interval (2, 12) Study 2 (Hand) Sample Size 198 187 Pain Intensity# Mean Outcome 40 47 Δ=7‡ at Week 6 95% Confidence Interval (1, 13)

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years at doses up to 2 mg/kg/day (approximately 0.5 and 1 times, respectively, the maximum recommended human topical dose of diclofenac sodium based on bioavailability and body surface area (BSA) comparison) resulted in no significant increases in tumor incidence. In a dermal carcinogenicity study conducted in albino mice, daily topical applications of a diclofenac sodium gel product for two years at concentrations up to 0.035% diclofenac sodium (a 29-fold lower diclofenac sodium concentration than present in diclofenac sodium topical gel) did not increase neoplasm incidence.

In a photococarcinogenicity study conducted in hairless mice, topical application of a diclofenac sodium gel product at doses up to 0.035% diclofenac sodium (a 29-fold lower diclofenac sodium concentration than present in diclofenac sodium topical gel) resulted in an earlier median time of onset of tumors. Mutagenesis Diclofenac was not mutagenic or clastogenic in a battery of genotoxicity tests that included the bacterial reverse mutation assay, in vitro mouse lymphoma point mutation assay, chromosomal aberration studies in Chinese hamster ovarian cells in vitro , and in vivo rat chromosomal aberration assay of bone marrow cells.

Impairment of Fertility Diclofenac did not affect male or female fertility in rats at doses up to 4 mg/kg/day (approximately 2 times than the maximum human topical dose of diclofenac sodium based on bioavailability and BSA comparison).

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL pdp

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diclofenac Sodium — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diclofenac Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$30M
Claims incl. refills
804.1K
Beneficiaries
539.2K
Spend / beneficiary
$55.63
Spend / claim
$37.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NuCare Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NuCare Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
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← 68071-3664-03 · NuCare 68071-3666-03 · NuCare →
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.