Manages mild to moderate pain. Sold as Neopap, Tylenol, Injectapap, Acephen, Acetaminophen and 2 more. Every FDA application for this active ingredient: 11 branded and 29 generic.
As of Nov 13, 2026, FDA lists 40 applications for Acetaminophen (sold as Neopap, Tylenol, Injectapap and others), first approved Nov 7, 1968, with 1 new use approved and 13 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Acetaminophen | Part D | $127K | +1% | 554 |
| Acetaminophen (J0131) | Part B | $17K | +60% | 1,482 |
| Acetaminophen (J0136) | Part B | $6K | -95% | 423 |
| Acetaminophen (J0134) | Part B | $0K | -100% | 0 |
| Acetaminophen (J0137) | Part B | $0K | -100% | 0 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 7, 1968 | NeopapNDA 16401 · New dosage form | Polymedica | 2 | Discontinued |
| May 26, 1976 | TylenolNDA 17756 · New formulation or manufacturer | J And J Consumer Inc | 0 | Discontinued |
| Feb 9, 1978 | AcephenNDA 18060 · New formulation or manufacturer | Cosette | 56 | Discontinued |
| Apr 22, 1980 | Acetaminophen, Infants' FeverallNDA 18337 · New formulation or manufacturer | Taro | 14 | Marketed |
| Dec 1, 1986 | AcetaminophenANDA 70608 | Perrigo New York | 5 | Marketed |
| Apr 6, 1987 | AcetaminophenANDA 70607 | Perrigo New York | 5 | Marketed |
| May 12, 1987 | AcetaminophenANDA 71010 | Acino Prods | 0 | Discontinued |
| May 12, 1987 | AcetaminophenANDA 71011 | Acino Prods | 0 | Discontinued |
| Mar 27, 1992 | AcephenANDA 72218 | Cosette Pharms Nc | 1 | Discontinued |
| Mar 27, 1992 | AcephenANDA 72237 | Cosette Pharms Nc | 8 | Discontinued |
| Mar 27, 1992 | AcephenANDA 72344 | Cosette Pharms Nc | 6 | Discontinued |
| Jun 8, 1994 | TylenolNDA 19872 · New dosage form | Kenvue Brands | 30 | Marketed |
| Feb 25, 2000 | AcetaminophenANDA 75077 | Perrigo | 6 | Marketed |
| Mar 19, 2002 | AcetaminophenANDA 76200 | Ohm Labs | 13 | Marketed |
| Nov 18, 2009 | AcetaminophenANDA 90205 | Sun Pharm Inds Ltd | 2 | Discontinued |
| Nov 2, 2010 | OfirmevNDA 22450 · New formulation or manufacturer | Mallinckrodt Hosp | 6 | Discontinued |
| Dec 14, 2011 | AcetaminophenANDA 78569 | Sun Pharm Inds Ltd | 2 | Discontinued |
| Oct 28, 2015 | AcetaminophenNDA 204767 · New formulation or manufacturer | Fresenius Kabi USA | 3 | Marketed |
| Mar 22, 2016 | AcetaminophenANDA 204052 | Sandoz | 2 | Marketed |
| Jun 13, 2016 | AcetaminophenANDA 202605 | Hikma | 0 | Marketed |
| Nov 9, 2016 | AcetaminophenANDA 207229 | Aurobindo Pharma | 4 | Marketed |
| May 31, 2018 | AcetaminophenANDA 207035 | Heritage | 0 | Discontinued |
| Apr 16, 2019 | AcetaminophenANDA 211544 | Granules | 1 | Marketed |
| Aug 7, 2020 | AcetaminophenANDA 213255 | Mylan | 0 | Marketed |
| Oct 21, 2020 | AcetaminophenANDA 210969 | Eugia Pharma | 0 | Marketed |
| Jan 15, 2021 | AcetaminophenNDA 206610 · New formulation or manufacturer | Rising | 0 | Discontinued |
| Feb 18, 2021 | AcetaminophenNDA 204957 · New formulation or manufacturer | B Braun Medical | 0 | Marketed |
| Aug 25, 2021 | AcetaminophenANDA 215486 | Pharmazone | 0 | Marketed |
| Sep 17, 2021 | AcetaminophenANDA 214331 | Baxter Hlthcare Corp | 0 | Marketed |
| Jun 3, 2022 | AcetaminophenNDA 206968 · New formulation or manufacturer | Hikma | 1 | Marketed |
| Jul 27, 2022 | AcetaminophenANDA 216617 | Aspiro | 0 | Marketed |
| Oct 25, 2022 | AcetaminophenANDA 216467 | Zydus Pharms | 0 | Discontinued |
| Apr 18, 2023 | AcetaminophenANDA 205746 | Apotex | 0 | Marketed |
| May 3, 2023 | AcetaminophenANDA 215403 | Inforlife | 0 | Marketed |
| Apr 2, 2025 | AcetaminophenANDA 219215 | Gland | 0 | Marketed |
| Dec 5, 2025 | AcetaminophenANDA 219096 | Caplin | 0 | Marketed |
| — | AcetaminophenANDA 73106 | Able | 0 | Discontinued |
| — | AcetaminophenANDA 73107 | Able | 0 | Discontinued |
| — | AcetaminophenANDA 73108 | Able | 0 | Discontinued |
| — | InjectapapNDA 17785 | Ortho Mcneil Pharm | 0 | Discontinued |
| Letter | Product | Now |
|---|---|---|
| Dec 22, 2020 | AcetaminophenNonclinical, Product Quality, Identified Issue | Approved |
| Apr 24, 2020 | AcetaminophenFacility Inspections | Approved |
| Jun 6, 2019 | AcetaminophenFacility Inspections | Approved |
| Mar 27, 2019 | AcetaminophenFacility Inspections | Approved |
| Nov 9, 2018 | AcetaminophenNonclinical, Facility Inspections | Approved |
| Dec 6, 2017 | NDA 206610Nonclinical | Approved |
| Sep 28, 2017 | AcetaminophenFacility Inspections | Approved |
| Feb 1, 2017 | AcetaminophenNonclinical | Approved |
| Nov 15, 2016 | AcetaminophenNonclinical, Facility Inspections | Approved |
| Mar 10, 2016 | AcetaminophenNonclinical | Approved |
| Feb 27, 2015 | AcetaminophenNonclinical, Product Quality, Facility Inspections | Approved |
| Feb 27, 2015 | AcetaminophenNonclinical, Facility Inspections | Approved |
| Feb 10, 2010 | Ofirmev (acetaminophen)Facility Inspections, Labeling | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
Perrigo
Sandoz
Aurobindo Pharma
Apotex