Active ingredient
Diclofenac
446 finished FDA listings contain Diclofenac as their only active ingredient; 32 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DICLOFENAC, DICLOFENAC DIETHYLAMINE, DICLOFENAC EPOLAMINE, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM
- Dosage forms
- Capsule, Liquid Filled, Gel, Patch, Powder, For Solution, Solution, Solution/ Drops, System, Tablet, Tablet, Coated, Tablet, Delayed Release, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Ophthalmic, Oral, Topical, Transdermal
- Manufacturers / labelers
- 162
- Strengths listed
- .01 g/g · .0125 g/g · .013 g/1 · 1 g/100g · 1 mg/100g · 1 mg/g · 1 mg/ml · 10 mg/g · 100 mg/1 · 16.05 mg/ml · 20 mg/g · 25 mg/1 · 30 mg/g · 50 mg/1 · 75 mg/1 · 9.3 mg/g
- Brand names in FDA listings
- Aleve Arthritis Pain Gel, Amazon Basic Care Arthritis Pain, Arthritis Pain, Arthritis Pain Relief, Arthritis Pain Reliever, Arthritis Pain Relieving, Aspercreme Arthritis, Basic Care Arthritis Pain, Cambia, Careone Arthritis Pain Relief, Crcle Diclofenac Sodium Topical Gel 1%, Curist Arthritis Relief, Dg Health Arthritis Pain, Diclofenac, Diclofenac Dr, Diclofenac Potassium, Diclofenac Sodium, Diclofenac Sodium 1.5%, Diclofenac Sodium Delayed Release, Diclofenac Sodium Dr, Diclofenac Sodium Er, Diclofenac Sodium Topical, Diclofenac Sodium Topical 1%, Diclofenac Sodium Topical Gel 1%, Diclox Patch 30ct, Dolo-Neurobion Arthritis Pain, Equaline Arthritis Pain Relieving, Equate Arthritis Pain, Flector, Foster And Thrive Arthritis Pain, Gencare-Arthritis Pain Relief, Good Sense Arthritis Pain, Kirkland Signature Arthritis Pain Relief, Licart, Lofena, Members Mark Arthritis Pain Reliever, Motrin Arthritis Pain, Salonpas, Topcare Arthritis Pain Reliever, Topcare Athritis Pain Reliever, Up And Up Arthritis Pain Reliever, Voltaren Arthritis Pain, Xiclo, Zipsor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3355
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 074514 | ACTAVIS ELIZABETH | 1996-03-26 | 11 |
| ANDA 075219 | TEVA | 1998-08-06 | 5 |
| ANDA 075185 | CARLSBAD | 1998-11-13 | 57 |
| ANDA 075229 | RUBICON RESEARCH | 1998-11-20 | 11 |
| ANDA 075463 | RISING | 1999-07-26 | 3 |
| ANDA 075492 | VPNA | 2000-02-11 | 6 |
| ANDA 075281 | AUROBINDO PHARMA USA | 2002-02-12 | 8 |
| ANDA 076201 | DEXCEL LTD | 2002-11-06 | 4 |
| ANDA 076561 | AMICI PHARMA | 2004-03-18 | 5 |
| NDA 021234 | IBSA | 2007-01-31 | 13 |
| ANDA 077863 | UNIQUE | 2007-06-08 | 15 |
| NDA 022122 | HALEON US HOLDINGS | 2007-10-17 | 2 |
| NDA 022202 | COSETTE | 2009-06-16 | 4 |
| ANDA 090066 | UNIQUE | 2010-12-01 | 14 |
| ANDA 203818 | SUN PHARMA CANADA | 2014-11-26 | 10 |
| ANDA 204132 | LUPIN | 2015-08-20 | 8 |
| ANDA 206493 | ACTAVIS MID ATLANTIC | 2015-12-02 | 3 |
| ANDA 205878 | NOVEL LABS INC | 2015-12-09 | 2 |
| ANDA 208077 | AMNEAL PHARMS | 2016-03-18 | 19 |
| ANDA 206298 | SUN PHARMA CANADA | 2016-04-28 | 8 |
| ANDA 206116 | AMNEAL PHARMS | 2016-09-02 | 12 |
| ANDA 208301 | GLENMARK PHARMS LTD | 2016-09-13 | 9 |
| ANDA 210893 | PADAGIS ISRAEL | 2018-07-27 | 6 |
| ANDA 209903 | CIPLA | 2018-08-03 | 7 |
| ANDA 204306 | AUROLIFE PHARMA LLC | 2019-05-06 | 13 |
| ANDA 211253 | PERRIGO PHARMA INTL | 2019-05-16 | 40 |
| ANDA 210078 | ONESOURCE | 2019-12-03 | 5 |
| ANDA 210986 | ENCUBE | 2020-01-27 | 32 |
| ANDA 215585 | INGENUS PHARMS LLC | 2021-10-08 | 5 |
| ANDA 207714 | APOTEX | 2022-05-06 | 5 |
| ANDA 215750 | UMEDICA | 2022-05-11 | 7 |
| ANDA 212351 | ALEMBIC | 2022-07-27 | 10 |
| ANDA 208021 | LUPIN PHARMS | 2022-09-21 | 7 |
| ANDA 216275 | INGENUS PHARMS LLC | 2022-09-23 | 7 |
| ANDA 208098 | SUN PHARMA CANADA | 2022-09-29 | 3 |
| ANDA 212506 | ALEMBIC | 2022-11-29 | 5 |
| ANDA 213040 | AUROLIFE PHARMA LLC | 2023-02-03 | 8 |
| ANDA 215787 | SENORES PHARMS | 2023-03-15 | 15 |
| ANDA 216548 | RUBICON RESEARCH | 2023-05-11 | 10 |
| ANDA 219945 | UMEDICA | 2025-11-05 | 3 |
Showing 40 of 59 applications.
Official labeling on DailyMed
- DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL) GEL [ALEMBIC PHARMACEUTICALS INC.] · version 14 · 2026-09-11
- DICLOFENAC SODIUM TABLET, DELAYED RELEASE [NORTHWIND HEALTH COMPANY, LLC] · version 1 · 2026-09-07
- ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [ASSERTIO SPECIALTY PHARMACEUTICALS LLC] · version 1 · 2026-09-07
- DICLOFENAC SODIUM TABLET, DELAYED RELEASE [NORTHWIND HEALTH COMPANY, LLC] · version 2 · 2026-09-07
- DICLOFENAC SODIUM TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-09-04
- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] · version 12 · 2026-09-03
- DICLOFENAC (DICLOFENAC SODIUM) GEL [YYBA CORP] · version 1 · 2026-09-02
- DICLOFENAC EPOLAMINE SYSTEM [SPORTPHARM LLC] · version 1 · 2026-08-26
- AMAZON BASIC CARE ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL [AMAZON.COM SERVICES LLC] · version 3 · 2026-08-21
- DICLOFENAC SODIUM TABLET, DELAYED RELEASE [SPORTPHARM LLC] · version 5 · 2026-08-19
- DICLOFENAC SODIUM GEL [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-17
- DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] · version 24 · 2026-08-14
Showing the 12 most recent of 409 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.