Active ingredient
Acetaminophen
1,103 finished FDA listings contain Acetaminophen as their only active ingredient; 2,399 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ACETAMINOPHEN
- Dosage forms
- Bar, Chewable, Capsule, Capsule, Coated, Capsule, Gelatin Coated, Capsule, Liquid Filled, Chewable Gel, Gel, Granule, For Solution, Injection, Injection, Solution, Liquid, Powder, Solution, Strip, Suppository, Suspension, Syrup, Tablet, Tablet, Chewable, Tablet, Coated, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release, Tablet, Orally Disintegrating
- Routes
- Intravenous, Oral, Rectal
- Manufacturers / labelers
- 314
- Strengths listed
- .5 g/24g · .5 g/g · 10 mg/ml · 1000 mg/100ml · 1000 mg/30ml · 120 mg/1 · 160 mg/1 · 160 mg/5ml · 250 mg/1 · 325 mg/1 · 325 mg/10.15ml · 500 mg/.95g · 500 mg/1 · 500 mg/15ml · 650 mg/1 · 650 mg/20.3ml · 675 mg/15ml · 80 mg/1 · 960 mg/30ml
- Brand names in FDA listings (first 80 of 339, A–Z)
- 365 Whole Foods Market Acetaminophen, 8 Hour Arthritis Pain, 8 Hour Pain Relief, 8 Hr Arthritis Pain, 8 Hr Arthritis Pain Relief, 8 Hr Muscle Aches And Pain, 8 Hr Pain Relief, 8hr Arthritis Pain, 8hr Arthritis Pain Relief, 8hr Muscle Aches And Pain, 8hr Muscle Aches And Pain Relief, 8hr Pain Relief, Acetaminophen, Acetaminophen (Red), Acetaminophen 325 Mg, Acetaminophen 325mg, Acetaminophen 325mg Rs, Acetaminophen 500 Mg, Acetaminophen 500mg Es, Acetaminophen 650mg, Acetaminophen Caplets, Acetaminophen Easy Tabs Extra Strength, Acetaminophen Extended-Release, Acetaminophen Extended-Release Tablets, 650 Mg, Acetaminophen Extra Strength, Acetaminophen For Children, Acetaminophen Gelcaps, Acetaminophen Gelcaps Extra Strength, Acetaminophen Pain Reliever Fever Reducer, Acetaminophen Regular Strength, Acetaminophen Solution, Adwe Childrens Pain Fever, Adwe Feverx Acetaminophen Caplets, 500 Mg Extra Strength, Aerotab Non-Aspirin, Amazon Basic Care Acetaminophen, Amazon Basics Acetaminophen, Apap, Aphen, Arthritis Pain, Arthritis Pain Acetaminophen, Arthritis Pain Relief, Arthritis Pain Reliever, Atamel Forte, Aurophen Extra Strength For Adults, Aurophen Regular Strength, Bactimicina Childrens Pain And Fever, Basic Care Acetaminophen, Basic Care Childrens Pain And Fever, Basic Care Infants Pain And Fever, Berkley And Jensen Acetaminophen, Berkley And Jensen Pain Relief, Berkley And Jensen Rapid Release Acetaminophen, Better Living Brands Childrens Fever And Pain Reliver, Cabinet Pain Reliever And Fever Reducer Refill Acetaminophen, Calmour Childrens Acetaminophen Strips Chewable, Care One Arthritis Pain Relief, Careall Acetaminophen, Careall Acetaminophen Extra Strength, Careall Non Aspirin Extra Strength, Careone 8 Hour Pain Relief, Careone Acetaminophen, Careone Childrens Acetaminophen, Careone Infants Acetaminophen, Cetafen, Cetafen Extra, Chewable Acetaminophen Childrens, Children Acetaminophen, Children Acetaminophen Oral Solution, Children Pain And Fever Reliever, Children Pain And Fever Reliver, Childrens Acetaminophen, Childrens Acetaminophen Dye Free Grape, Childrens Acetaminophen Oral Liquid Grape Flavor, Childrens Acetaminophen Oral Suspension, Childrens Chewable Acetaminophen, Childrens Chewables, Childrens Fever Reducer And Pain Reliever, Childrens Mapap, Childrens Pain And Fever, Childrens Pain And Fever Cherry Flavor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 161
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 018337 | TARO | 1980-04-22 | 3 |
| ANDA 070608 | PERRIGO NEW YORK | 1986-12-01 | 2 |
| ANDA 070607 | PERRIGO NEW YORK | 1987-04-06 | 8 |
| NDA 019872 | KENVUE BRANDS | 1994-06-08 | 2 |
| ANDA 075077 | PERRIGO | 2000-02-25 | 30 |
| ANDA 076200 | OHM LABS | 2002-03-19 | 1 |
| ANDA 078569 | SUN PHARM INDS LTD | 2011-12-14 | 2 |
| NDA 204767 | FRESENIUS KABI USA | 2015-10-28 | 1 |
| ANDA 204052 | SANDOZ | 2016-03-22 | 3 |
| ANDA 202605 | HIKMA | 2016-06-13 | 4 |
| ANDA 207229 | AUROBINDO PHARMA | 2016-11-09 | 12 |
| ANDA 211544 | GRANULES | 2019-04-16 | 60 |
| ANDA 213255 | MYLAN | 2020-08-07 | 1 |
| ANDA 210969 | EUGIA PHARMA | 2020-10-21 | 3 |
| NDA 204957 | B BRAUN MEDICAL | 2021-02-18 | 4 |
| ANDA 215486 | MARKSANS PHARMA | 2021-08-25 | 20 |
| ANDA 214331 | BAXTER HLTHCARE CORP | 2021-09-17 | 2 |
| NDA 206968 | HIKMA | 2022-06-03 | 1 |
| ANDA 216617 | ASPIRO | 2022-07-27 | 1 |
| ANDA 215403 | INFORLIFE | 2023-05-03 | 1 |
| ANDA 219215 | GLAND | 2025-04-02 | 3 |
| ANDA 219096 | CAPLIN | 2025-12-05 | 2 |
Official labeling on DailyMed
- PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [RITE AID CORPORATION] · version 26 · 2026-09-11
- INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY] · version 7 · 2026-09-10
- PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [DOLGENCORP, LLC] · version 13 · 2026-09-10
- ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC] · version 18 · 2026-09-10
- CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION] · version 4 · 2026-09-10
- ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [CVS PHARMACY] · version 18 · 2026-09-10
- UP AND UP CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [TARGET CORPORATION] · version 2 · 2026-09-10
- PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN COMPANY] · version 26 · 2026-09-10
- CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) TABLET, CHEWABLE [FSA STORE INC.] · version 2 · 2026-09-10
- PENTREXCILINA (ACETAMINOPHEN) SUSPENSION [OPMX LLC] · version 1 · 2026-09-07
- DESENFRIOL-ITO PLUS (ACETAMINOPHEN) SUSPENSION [OPMX LLC] · version 1 · 2026-09-07
- MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX] · version 1 · 2026-09-07
Showing the 12 most recent of 1,035 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.