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Arthritis Pain Reliever

Diclofenac sodium · Gel

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Arthritis Pain Reliever
Generic name
Diclofenac sodium
Dosage form
Gel
Route
Topical
Marketing category
ANDA · ANDA
Labeler
CVS PHARMACY, INC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
12
Packages
21
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Diclofenac Sodium 10 mg/g 855633 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Gel
Route of administration
Topical
Presentations
33

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Decreased Prostaglandin Production [PE] PE All 54 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
208077
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 18, 2016
Sponsor
AMNEAL PHARMS
Products on application
1
Submissions recorded
2
Products approved under application 208077.
Product Trade name Form Strength Ingredient Status TE Flags
208077-001 DICLOFENAC SODIUM GEL DICLOFENAC SODIUM Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 208077.
Type No. Action Status Date Review
Supplement 11 Labeling Approved August 13, 2020 Standard
Original application 1 Approved March 18, 2016 Standard

Review documents

  • 0 · Original application · February 15, 2019

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251117). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251117 HUMAN OTC DRUG · 20221215

Indications and Usage

openFDA Drug Labeling

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.

Purpose Arthritis pain reliever

Dosage and Administration

openFDA Drug Labeling

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 the 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% product. The dosing card is re-usable.

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 nonprescription 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 is you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to any other pain reliever or to a fever reducer • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. • right before or after heart surgery • on more than 2 body areas at the same time • in the eyes, nose or mouth Ask a doctor before use if • you have problems or serious side effects from taking pain relievers or fever reducers • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other drug When using this product • avoid contact with eyes, nose, or mouth • if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if • pain gets worse or lasts more than 21 days • redness or swelling is present in the painful area • fever occurs • skin irritation occurs • any new symptoms appear. These could be signs of a serious condition. • you experience any of the following signs of stomach bleeding: • feel faint • have bloody or black stools • vomit blood • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • leg swelling • weakness in one part or side of body • slurred speech If pregnant or breast feeding, ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use • if you have ever had an allergic reaction to any other pain reliever or to a fever reducer • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. • right before or after heart surgery • on more than 2 body areas at the same time • in the eyes, nose or mouth

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.

Stop use and ask a doctor if • pain gets worse or lasts more than 21 days • redness or swelling is present in the painful area • fever occurs • skin irritation occurs • any new symptoms appear. These could be signs of a serious condition. • you experience any of the following signs of stomach bleeding: • feel faint • have bloody or black stools • vomit blood • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • leg swelling • weakness in one part or side of body • slurred speech

Active Ingredient

openFDA Drug Labeling

Active ingredient Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) * nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
155,967
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DICLOFENAC SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
46122-752-37 46122-752 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 TUBE in 1 CARTON (46122-752-37) / 50 g in 1 TUBE April 1, 2023
46122-752-52 46122-752 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 TUBE in 1 CARTON (46122-752-52) / 100 g in 1 TUBE April 1, 2023
46122-752-53 46122-752 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 TUBE in 1 CARTON (46122-752-53) / 150 g in 1 TUBE April 1, 2023
51316-012-15 51316-012 CVS PHARMACY, INC 1 TUBE in 1 CARTON (51316-012-15) / 150 g in 1 TUBE February 4, 2022
51316-073-76 51316-073 CVS PHARMACY, INC 1 TUBE in 1 CARTON (51316-073-76) / 50 g in 1 TUBE September 30, 2021
68016-171-00 68016-171 Chain Drug Consortium, LLC 1 TUBE in 1 CARTON (68016-171-00) / 100 g in 1 TUBE December 31, 2022
68016-171-50 68016-171 Chain Drug Consortium, LLC 1 TUBE in 1 CARTON (68016-171-50) / 50 g in 1 TUBE December 31, 2022
55319-969-17 55319-969 Family Dollar (FAMILY WELLNESS) 1 TUBE in 1 CARTON (55319-969-17) / 50 g in 1 TUBE May 15, 2023
37808-087-01 37808-087 H E B 1 TUBE in 1 CARTON (37808-087-01) / 100 g in 1 TUBE August 6, 2020
37808-087-02 37808-087 H E B 1 TUBE in 1 CARTON (37808-087-02) / 50 g in 1 TUBE November 12, 2020
37808-087-03 37808-087 H E B 1 TUBE in 1 CARTON (37808-087-03) / 150 g in 1 TUBE November 18, 2020
59640-198-01 59640-198 H E B 1 TUBE in 1 CARTON (59640-198-01) / 100 g in 1 TUBE July 18, 2025
59640-198-02 59640-198 H E B 1 TUBE in 1 CARTON (59640-198-02) / 50 g in 1 TUBE September 16, 2025
59640-198-03 59640-198 H E B 1 TUBE in 1 CARTON (59640-198-03) / 150 g in 1 TUBE April 22, 2025
42507-150-01 42507-150 HyVee Inc 1 TUBE in 1 CARTON (42507-150-01) / 100 g in 1 TUBE (42507-150-00) April 23, 2026
59726-012-50 59726-012 P & L Development, LLC 1 TUBE in 1 CARTON (59726-012-50) / 50 g in 1 TUBE June 25, 2021
59726-012-53 59726-012 P & L Development, LLC 1 TUBE in 1 CARTON (59726-012-53) / 100 g in 1 TUBE June 25, 2021
56062-471-02 56062-471 Publix Super Markets Inc 1 TUBE in 1 CARTON (56062-471-02) / 50 g in 1 TUBE September 12, 2025
56062-878-01 56062-878 Publix Super Markets Inc 1 TUBE in 1 CARTON (56062-878-01) / 100 g in 1 TUBE February 22, 2021
56062-878-02 56062-878 Publix Super Markets Inc 1 TUBE in 1 CARTON (56062-878-02) / 50 g in 1 TUBE February 1, 2021
83324-306-01 83324-306 QUALITY CHOICE (Chain Drug Marketing Association) 1 TUBE in 1 CARTON (83324-306-01) / 100 g in 1 TUBE August 1, 2024
46122-752 46122-752 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — April 1, 2023
51316-012 51316-012 CVS PHARMACY, INC — February 4, 2022
51316-073 51316-073 CVS PHARMACY, INC — September 30, 2021
68016-171 68016-171 Chain Drug Consortium, LLC — December 31, 2022
55319-969 55319-969 Family Dollar (FAMILY WELLNESS) — May 15, 2023
37808-087 37808-087 H E B — August 6, 2020
59640-198 59640-198 H E B — April 22, 2025
42507-150 42507-150 HyVee Inc — April 23, 2026
59726-012 59726-012 P & L Development, LLC — June 25, 2021
56062-471 56062-471 Publix Super Markets Inc — September 12, 2025
56062-878 56062-878 Publix Super Markets Inc — February 1, 2021
83324-306 83324-306 QUALITY CHOICE (Chain Drug Marketing Association) — August 1, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.