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Active ingredient

Naproxen

468 finished FDA listings contain Naproxen as their only active ingredient; 59 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
NAPROXEN, NAPROXEN SODIUM
Dosage forms
Capsule, Capsule, Liquid Filled, Suspension, Tablet, Tablet, Coated, Tablet, Delayed Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
170
Strengths listed
125 mg/5ml · 200 mg/1 · 220 mg/1 · 25 mg/ml · 250 mg/1 · 275 mg/1 · 375 mg/1 · 500 mg/1 · 550 mg/1 · 750 mg/1
Brand names in FDA listings
24/7 Life By 7-Eleven Naproxen Sodium, Aleve, Aleve Back And Muscle Pain, Aleve Caplets, Aleve Caplets - Easy Open Arthritis Cap, Aleve Caplets Easy Open Arthritis, Aleve Caplets Soft Grip Arthritis, Aleve Easy Open Arthritis, Aleve Easy Open Arthritis Cap, Aleve Gelcaps, Aleve Headache Pain, Aleve Liquid Gels, Aleve, Travel Basix, All Day Back And Muscle Pain Relief, All Day Pain Relief, All Day Relief, Amazon Basic Care Naproxen Sodium, Ana-Dent Pain Relief, Anadent, Artridol, Back And Muscle Pain, Basic Care Naproxen Sodium, Bayer Aleve, Belmora Flanax, Berkley And Jensen Naproxen Sodium, Betr Headache Pain Relief, Calmadol Pain Reliever, Care One Naproxen Sodium, Careall Naproxen, Careall Naproxen Sodium, Careone Naproxen Sodium, Dg Health Naproxen Sodium, Dr Simi All Day Pain Relief, Equaline Naproxen Sodium, Exchange Select Naproxen Sodium, First Aid Direct All Day Pain Relief, Flanax, Flanax Menstrual Pain Reliever, Flanax Pain Reliever/Fever Reducer, Foster And Thrive All Day Pain Relief, Good Sense Naproxen Sodium, Kirkland Signature Naproxen Sodium, Leader All Day Pain Relief, Lil Drug Store Pain Relief All Day, Medique At Home Mediproxen, Medique Mediproxen, Naprelan, Naproxen, Naproxen Back And Muscle Pain, Naproxen Caplets, Naproxen Caplets All Day Relief For Pain, Naproxen Headache Pain, Naproxen Oral Suspension, Naproxen Sodium, Naproxen Sodium (Nsaid) Fever Reducer/ Pain Reliever, Naproxen Sodium Back And Muscle Pain, Naproxen Sodium Back And Muscle Pain Caplets, Naproxen Sodium Caplets, Naproxen Sodium Headache Pain, Naproxen Sodium Headache Pain Caplets, Pain Relief, Proxen Np 660, Rapidol Naproxen, Rugby All Day Relief, Signature Care Naproxen Sodium, Topcare All Day Pain Relief, Topcare Back And Muscle Pain, Up And Up Naproxen Sodium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7258

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
NDA 018965ATNAHS PHARMA US1987-03-231
ANDA 074140GRANULES1993-12-2111
NDA 020204BAYER1994-01-1127
ANDA 074190HIKMA1994-03-301
NDA 020067ATNAHS PHARMA US1994-10-141
NDA 020353TWI PHARMS1996-01-0511
ANDA 074661PERRIGO1997-01-1357
ANDA 075168DR REDDYS LABS INC1998-07-2811
ANDA 075390AUROBINDO PHARMA USA2001-04-192
ANDA 075927AMNEAL PHARMS NY2001-12-1823
ANDA 075416ACTAVIS LABS FL INC2002-08-273
NDA 021920BIONPHARMA2006-02-1722
ANDA 078250GLENMARK PHARMS LTD2007-03-2829
ANDA 078314GLENMARK PHARMS LTD2007-04-274
ANDA 078486DR REDDYS LABS LTD2007-07-266
ANDA 079096AMNEAL PHARMS NY2008-12-1632
ANDA 091416MARKSANS PHARMA2011-02-1418
ANDA 090545MARKSANS PHARMA2011-03-1623
ANDA 091305INVAGEN PHARMS2011-08-249
ANDA 091432NUVO PHARMS INC2011-09-1911
ANDA 091353GRANULES INDIA2011-09-2019
ANDA 200629AUROBINDO PHARMA LTD2011-10-315
ANDA 200429AUROBINDO PHARMA2011-11-0811
ANDA 205497AUROBINDO PHARMA LTD2016-03-1812
ANDA 204872LNK INTL INC2017-01-2329
ANDA 208363PURACAP PHARM LLC2018-03-1514
ANDA 202807CATALENT2019-01-042
ANDA 212199SCIEGEN PHARMS2019-10-3016
ANDA 212517SCIEGEN PHARMS2020-02-2150
ANDA 212705AMNEAL2020-07-311
ANDA 211910NOVITIUM PHARMA2021-03-101
ANDA 215776HETERO LABS LTD III2022-06-071
ANDA 211065HETERO LABS LTD V2022-10-281
ANDA 214463PATHEON SOFTGELS2023-01-101
ANDA 218497NOVITIUM PHARMA2024-06-122
ANDA 216504AUROBINDO PHARMA2025-10-031

Official labeling on DailyMed

Showing the 12 most recent of 388 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.