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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.

ApplicationSponsorOriginal approvalListings
ANDA 074514ACTAVIS ELIZABETH1996-03-2611
ANDA 075219TEVA1998-08-065
ANDA 075185CARLSBAD1998-11-1357
ANDA 075229RUBICON RESEARCH1998-11-2011
ANDA 075463RISING1999-07-263
ANDA 075492VPNA2000-02-116
ANDA 075281AUROBINDO PHARMA USA2002-02-128
ANDA 076201DEXCEL LTD2002-11-064
ANDA 076561AMICI PHARMA2004-03-185
NDA 021234IBSA2007-01-3113
ANDA 077863UNIQUE2007-06-0815
NDA 022122HALEON US HOLDINGS2007-10-172
NDA 022202COSETTE2009-06-164
ANDA 090066UNIQUE2010-12-0114
ANDA 203818SUN PHARMA CANADA2014-11-2610
ANDA 204132LUPIN2015-08-208
ANDA 206493ACTAVIS MID ATLANTIC2015-12-023
ANDA 205878NOVEL LABS INC2015-12-092
ANDA 208077AMNEAL PHARMS2016-03-1819
ANDA 206298SUN PHARMA CANADA2016-04-288
ANDA 206116AMNEAL PHARMS2016-09-0212
ANDA 208301GLENMARK PHARMS LTD2016-09-139
ANDA 210893PADAGIS ISRAEL2018-07-276
ANDA 209903CIPLA2018-08-037
ANDA 204306AUROLIFE PHARMA LLC2019-05-0613
ANDA 211253PERRIGO PHARMA INTL2019-05-1640
ANDA 210078ONESOURCE2019-12-035
ANDA 210986ENCUBE2020-01-2732
ANDA 215585INGENUS PHARMS LLC2021-10-085
ANDA 207714APOTEX2022-05-065
ANDA 215750UMEDICA2022-05-117
ANDA 212351ALEMBIC2022-07-2710
ANDA 208021LUPIN PHARMS2022-09-217
ANDA 216275INGENUS PHARMS LLC2022-09-237
ANDA 208098SUN PHARMA CANADA2022-09-293
ANDA 212506ALEMBIC2022-11-295
ANDA 213040AUROLIFE PHARMA LLC2023-02-038
ANDA 215787SENORES PHARMS2023-03-1515
ANDA 216548RUBICON RESEARCH2023-05-1110
ANDA 219945UMEDICA2025-11-053

Showing 40 of 59 applications.

Official labeling on DailyMed

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.