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Active ingredient

Ibuprofen

1,146 finished FDA listings contain Ibuprofen as their only active ingredient; 192 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN SODIUM
Dosage forms
Capsule, Capsule, Liquid Filled, Injection, Liquid, Solution, Suspension, Suspension/ Drops, Tablet, Tablet, Chewable, Tablet, Coated, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
283
Strengths listed
10 mg/ml · 100 mg/1 · 100 mg/100ml · 100 mg/10ml · 100 mg/5ml · 200 mg/1 · 200 mg/1000mg · 200 mg/10ml · 200 mg/1201 · 256 mg/1 · 300 mg/1 · 400 mg/1 · 50 mg/1.25ml · 600 mg/1 · 800 mg/1 · 800 mg/200ml · 800 mg/8ml
Brand names in FDA listings (first 80 of 164, A–Z)
365 Whole Foods Market Ibuprofen, Advil, Advil Liqui-Gels, Advil Liquigel, Advil Liquigels, Advil Menstrual Pain, Advil Migraine, Aerotab Ibuprofen, Amazon Basic Care Ibuprofen, Assured Ibuprofen, Basic Care Childrens Ibuprofen, Basic Care Ibuprofen, Basic Care Infants Ibuprofen, Berkley And Jensen Ibuprofen, Betr Pain Relief, Betr Remedies Ibuprofen, Cabinet Pain Reliever And Fever Reducer, Caldolor, Care One Ibuprofen, Care One Ibuprofen Childrens, Careall Ibuprofen, Careone Childrens Ibuprofen, Careone Ibuprofen, Childrens Advil, Childrens Flanax Oral, Childrens Ibuprofen, Childrens Ibuprofen 100, Childrens Ibuprofen 100 Dye Free, Childrens Ibuprofen 572, Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Bubblegum Dye Free, Childrens Ibuprofen Fruit, Childrens Ibuprofen Grape, Childrens Ibuprofen Oral Suspension, Childrens Ibuprofen Oral Suspension Dye Free, Childrens Ibuprofen Oral Suspension Original Berry Flavor, Childrens Ibuprofen Oral Suspension, Bubble Gum, Childrens Ibuprofen Oral Suspension, Dye Free, Childrens Motrin, Circle K Ibuprofen, Concentrated Ibuprofen Infants, Counteract Ib, Cvs Ibuprofen, Dg Health Childrens Ibuprofen, Dg Health Ibuprofen, Direct Safety Ibuprofen, Dolex Children, Dolex Flex, Dover Addaprin, Dye Free Childrens Ibuprofen, Dye Free Ibuprofen, Dye-Free Ibuprofen, Dye-Free Ibuprofen 200, Dye-Free Pain Relief, Equaline Childrens Ibuprofen, Equaline Ibuprofen, Equaline Ibuprofen Childrens, Equate Ibuprofen, Equate Ibuprofen Childrens, Fast Pain Relief, Flex-Prin, Foster And Thrive Childrens Ibuprofen Ib, Foster And Thrive Ibuprofen, Foster And Thrive Infants Ibuprofen, Good Neighbor Pharmacy Childrens Ibuprofen, Good Neighbor Pharmacy Ibuprofen, Good Neighbor Pharmacy Ibuprofen Childrens, Good Remedies Ibuprofen 200 Mg, Good Sense Childrens Ibuprofen, Good Sense Ibuprofen, Good Sense Ibuprofen Childrens, Good Sense Ibuprofen Infants, Good Sense Infants Ibuprofen, Goodmeds Ibuprofen 200mg, Goodnow Pain Relief, Green Guard Ibupro Relief, Green Guard Ibuprofen Relief, Henry Schein Ibuprofen, Ibu

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 5640

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 018989HALEON US HOLDINGS1984-05-1814
ANDA 071265ADAPTIS1986-10-153
ANDA 071268CONTRACT PHARMACAL1986-10-157
ANDA 072096PERRIGO1987-12-0868
NDA 020402HALEON US HOLDINGS1995-04-2010
NDA 020516KENVUE BRANDS1995-06-164
NDA 020589HALEON US HOLDINGS1996-06-277
ANDA 075217L PERRIGO CO1998-12-1631
ANDA 074937PERRIGO1998-12-2285
ANDA 075139LNK1999-03-0126
ANDA 075010LNK1999-03-0153
ANDA 075682DR REDDYS2001-11-1432
ANDA 076359PERRIGO2004-01-1637
ANDA 077349PERRIGO R AND D2005-06-2123
ANDA 078558AMNEAL PHARMS NY2007-06-1821
ANDA 078329STRIDES PHARMA2009-02-0543
ANDA 078682BIONPHARMA2009-03-2460
ANDA 079205MARKSANS PHARMA2009-06-2628
ANDA 079174GRANULES INDIA2010-12-1077
ANDA 090796MARKSANS PHARMA2010-12-2140
ANDA 091239MARKSANS PHARMA2011-02-0119
ANDA 091237MARKSANS PHARMA2011-02-0814
ANDA 079129STRIDES PHARMA2011-03-2821
ANDA 091355STRIDES PHARMA2011-04-044
ANDA 202300AMNEAL PHARMS2011-12-234
ANDA 091625GRANULES2015-09-1551
ANDA 206568HUMANWELL PURACAP2016-06-2144
ANDA 203599SOFGEN PHARMS2016-09-075
ANDA 202312GRANULES2016-10-0734
ANDA 202413SHANDONG XINHUA2016-11-2354
ANDA 207095SHANDONG XINHUA2017-05-059
ANDA 209207SUN PHARMA CANADA2017-06-279
ANDA 208865AUROBINDO PHARMA2017-11-086
ANDA 204469ONESOURCE2018-03-287
ANDA 209179AUROBINDO PHARMA LTD2018-04-1712
ANDA 207753AUROBINDO PHARMA LTD2018-06-298
ANDA 210149GUARDIAN DRUG2018-08-1714
ANDA 210755GUARDIAN DRUG2018-09-265
ANDA 210602ANNORA PHARMA2018-11-2340
ANDA 213794AUROBINDO PHARMA LTD2020-05-0847

Showing 40 of 73 applications.

Official labeling on DailyMed

Showing the 12 most recent of 986 labels.

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