NDC 68071-3483-01 — DICLOFENAC SODIUM 10 mg/g Gel

🆔 Identity & classification

FDA NDC (as labeled) 68071-3483-1

Product NDC 68071-3483

11-digit billing NDC 68071348301

UNII QTG126297Q

UPC 0368071348316

Application # ANDA210986

SPL Set ID 0326ea5b-3e1a-dee2-e063-6294a90a13b8

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 2020-09-14

Route TOPICAL

Dosage form GEL

Substance DICLOFENAC SODIUM

Why two NDCs? The FDA registers this code as 68071-3483-1 — 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 → 68071-3483-01. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.

Application holderENCUBE ETHICALS PRIVATE LTD

FDA applicationANDA210986 (ANDA)

Labeler code68071

First marketedSep 2020

Product typeHuman Otc Drug

Portfolio1,015 products on file

🔎 All NDCs from NuCare Pharmaceuticals,Inc.

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

📗 Our plain-language guide HelloPharmacist

An actinic keratosis — often just called an AK — is a rough, scaly patch on the skin caused by years of sun exposure. These patches are considered precancerous, meaning they could...
What exactly is an actinic keratosis, and why do I need a prescription gel for it?
The typical treatment course runs 60 to 90 days of twice-daily application — that's a solid commitment, but it's necessary for the gel to do its job. Here's the thing: even after y...
How long do I need to use this gel, and how will I know it's working?

📖 Read our full Diclofenac 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.

🧪 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.

💲 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 g	Per 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Arthritis Pain 10 mg/g 70677-1125-01	Strategic	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 71205-0747-00	Proficient	1 tube	—	—	FDA listed	—
Diclofenac Sodium Topical Gel 1% 10 mg/g 30142-0025-10	Kroger	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/gthis 68071-3483-01	NuCare	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 63868-0730-01	Chain	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 43598-0977-05	Dr.	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 62379-0401-02	Simple	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 57896-0140-01	GERI-CARE	1 tube	—	—	FDA listed	—
Diclofenac Sodium Topical Gel 1% 10 mg/g 00363-7065-10	Walgreens	1 tube	—	—	FDA listed	—
Arthritis Pain 10 mg/g 53943-0523-01	Discount	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 85766-0160-01	Sportpharm	1 tube	—	—	FDA listed	—
Diclofenac Sodium 10 mg/g 21922-0044-29	Encube	1 tube	—	—	Discontinued	—
Diclofenac Sodium 10 mg/g 43598-0885-10	Dr.	1 tube	—	—	FDA listed	—
Dolo-NeuroBion Arthritis Pain 10 mg/g 55959-0123-50	BENARD	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

🏛️

2020

On the market since

Sep 2020

📍

2026

Currently FDA-listed

6 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.

📊 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.

🔬 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 Diclofenac Sodium (this brand).

Top reported reactions

Pain12,732

Fatigue11,763

Rheumatoid Arthritis9,585

Rash9,190

Arthralgia9,056

Abdominal Discomfort8,779

Alopecia8,323

Age at onset

Neonate322

Infant30

Child39

Adolescent135

Adult9,014

Elderly3,962

Reporter sex

Serious outcomes

Hospitalization31,565

Death11,043

Life-threatening10,397

Disabling10,326

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
68071-3483-01 You're viewing this	1 TUBE in 1 CARTON (68071-3483-1) / 100 g in 1 TUBE	2023-08-17	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

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	— 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.
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)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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

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 FDA registers it as 68071-3483-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68071-3483-01, written without dashes as 68071348301. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 68071-3483-01, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (3483) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

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?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

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

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 53 words ▾

Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use

⏱️ Dosage and Administration 185 words ▾

Directions Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle or knee) –Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain.

The dosing card is re-usable.

⚠️ Warnings 191 words ▾

Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac.

Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

📦 Storage and Handling 59 words ▾

Other information Store at 20-25 o C (68°F - 77°F). Keep from freezing. read all product information before using. Keep the dossing card, the carton and accompanying User guide for important information. Inactive ingredients Carbomer homopolymer Type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution. Question and comments 1-833-285-4151

🧪 Active Ingredient 9 words ▾

Active ingredient Diclofenac sodium (NSAID*) 1% *nonsteroidal anti‑inflammatory drug

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients Inactive ingredients: Carbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

🎯 Purpose 4 words ▾

Purpose Arthritis pain reliever

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

🔗 Related NDC lookups

🧪 All Diclofenac Sodium Topical Gel, 1% NDCsSame ingredient 🏭 All NuCare labeler NDCsLabeler code 68071 📚 All Nonsteroidal Anti-inflammatory Drug NDCsDrug class