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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018989 | HALEON US HOLDINGS | 1984-05-18 | 14 |
| ANDA 071265 | ADAPTIS | 1986-10-15 | 3 |
| ANDA 071268 | CONTRACT PHARMACAL | 1986-10-15 | 7 |
| ANDA 072096 | PERRIGO | 1987-12-08 | 68 |
| NDA 020402 | HALEON US HOLDINGS | 1995-04-20 | 10 |
| NDA 020516 | KENVUE BRANDS | 1995-06-16 | 4 |
| NDA 020589 | HALEON US HOLDINGS | 1996-06-27 | 7 |
| ANDA 075217 | L PERRIGO CO | 1998-12-16 | 31 |
| ANDA 074937 | PERRIGO | 1998-12-22 | 85 |
| ANDA 075139 | LNK | 1999-03-01 | 26 |
| ANDA 075010 | LNK | 1999-03-01 | 53 |
| ANDA 075682 | DR REDDYS | 2001-11-14 | 32 |
| ANDA 076359 | PERRIGO | 2004-01-16 | 37 |
| ANDA 077349 | PERRIGO R AND D | 2005-06-21 | 23 |
| ANDA 078558 | AMNEAL PHARMS NY | 2007-06-18 | 21 |
| ANDA 078329 | STRIDES PHARMA | 2009-02-05 | 43 |
| ANDA 078682 | BIONPHARMA | 2009-03-24 | 60 |
| ANDA 079205 | MARKSANS PHARMA | 2009-06-26 | 28 |
| ANDA 079174 | GRANULES INDIA | 2010-12-10 | 77 |
| ANDA 090796 | MARKSANS PHARMA | 2010-12-21 | 40 |
| ANDA 091239 | MARKSANS PHARMA | 2011-02-01 | 19 |
| ANDA 091237 | MARKSANS PHARMA | 2011-02-08 | 14 |
| ANDA 079129 | STRIDES PHARMA | 2011-03-28 | 21 |
| ANDA 091355 | STRIDES PHARMA | 2011-04-04 | 4 |
| ANDA 202300 | AMNEAL PHARMS | 2011-12-23 | 4 |
| ANDA 091625 | GRANULES | 2015-09-15 | 51 |
| ANDA 206568 | HUMANWELL PURACAP | 2016-06-21 | 44 |
| ANDA 203599 | SOFGEN PHARMS | 2016-09-07 | 5 |
| ANDA 202312 | GRANULES | 2016-10-07 | 34 |
| ANDA 202413 | SHANDONG XINHUA | 2016-11-23 | 54 |
| ANDA 207095 | SHANDONG XINHUA | 2017-05-05 | 9 |
| ANDA 209207 | SUN PHARMA CANADA | 2017-06-27 | 9 |
| ANDA 208865 | AUROBINDO PHARMA | 2017-11-08 | 6 |
| ANDA 204469 | ONESOURCE | 2018-03-28 | 7 |
| ANDA 209179 | AUROBINDO PHARMA LTD | 2018-04-17 | 12 |
| ANDA 207753 | AUROBINDO PHARMA LTD | 2018-06-29 | 8 |
| ANDA 210149 | GUARDIAN DRUG | 2018-08-17 | 14 |
| ANDA 210755 | GUARDIAN DRUG | 2018-09-26 | 5 |
| ANDA 210602 | ANNORA PHARMA | 2018-11-23 | 40 |
| ANDA 213794 | AUROBINDO PHARMA LTD | 2020-05-08 | 47 |
Showing 40 of 73 applications.
Official labeling on DailyMed
- IBUPROFEN TABLET, FILM COATED [AMAZON.COM SERVICES LLC] · version 3 · 2026-09-11
- IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] · version 5 · 2026-09-10
- IBUPROFEN TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-10
- IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [RITE AID CORPORATION] · version 8 · 2026-09-10
- IBUPROFEN MINIS (IBUPROFEN) CAPSULE, LIQUID FILLED [THE KROGER CO.] · version 7 · 2026-09-10
- IBUPROFEN CAPSULE, LIQUID FILLED [THE KROGER CO.] · version 9 · 2026-09-10
- IBUPROFEN CAPSULE, LIQUID FILLED [GOODSENSE] · version 2 · 2026-09-10
- IBUPROFEN TABLET, COATED [LIDL US LLC] · version 5 · 2026-09-10
- IBUPROFEN TABLET [MAJOR PHARMACEUTICALS] · version 30 · 2026-09-07
- IBUPROFEN TABLET, FILM COATED [DIRECT_RX] · version 4 · 2026-09-07
- IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC] · version 7 · 2026-09-04
- IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC] · version 4 · 2026-09-04
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.