Manages mild to moderate acute pain. Sold as Combogesic, Advil Dual Action With Acetaminophen. Every FDA application for this active ingredient: 2 branded and 10 generic.
As of Nov 15, 2026, FDA lists 12 applications for Acetaminophen; Ibuprofen (sold as Combogesic, Advil Dual Action With Acetaminophen), first approved Feb 28, 2020, with 0 new uses approved and 2 published complete response letters.
| Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.Caffeine, Hypoxia · Liverpool John Moores University | Phase 4 | Recruiting | Nov 13, 2026 |
| Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami | Phase 4 | Not yet recruiting | Nov 12, 2026 |
| Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain ManagementPelvic Organ Prolapse (POP), Postoperative Pain · Aditi Talkad | Phase 4 | Not yet recruiting | Oct 2, 2026 |
| Suzetrigine Versus Standard Analgesia After Skin Cancer SurgeryPostoperative Pain, Acute Pain · University of Minnesota | Phase 4 | Not yet recruiting | Sep 25, 2026 |
| Post-Vasectomy Pain StudyVasectomy, NSAIDs · Columbia University | Phase 1 | Recruiting | Sep 17, 2026 |
| Post-op Analgesia of Nail Unit ProceduresNail Diseases · University of Miami | Phase 4 | Not yet recruiting | Sep 15, 2026 |
| Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral PalsyCerebral Palsy, Postoperative Pain · Diskapi Yildirim Beyazit Education and Research Hospital | Not applicable | Recruiting | Sep 3, 2026 |
| Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)Breast Cancer, Aromatase Inhibitor · Ilsan Cha hospital | Not applicable | Recruiting | Aug 27, 2026 |
| Feb 28, 2020 | Advil Dual Action With AcetaminophenNDA 211733 · New combination | Haleon US Holdings | 3 | Marketed |
| Feb 28, 2023 | Acetaminophen And IbuprofenANDA 214836 | L Perrigo Co | 3 | Marketed |
| Mar 1, 2023 | CombogesicNDA 209471 · New combination | Aft Pharms US | 1 | Marketed |
| Jul 10, 2023 | Acetaminophen And IbuprofenANDA 216994 | Pharmazone | 0 | Marketed |
| Jul 13, 2023 | Acetaminophen And IbuprofenANDA 216592 | Granules | 3 | Marketed |
| Aug 1, 2023 | Acetaminophen And IbuprofenANDA 216999 | Bionpharma | 0 | Marketed |
| Mar 26, 2024 | Acetaminophen And IbuprofenANDA 218359 | Aurobindo Pharma Ltd | 2 | Marketed |
| Apr 26, 2024 | Acetaminophen And IbuprofenANDA 218311 | Glenmark Pharms Ltd | 0 | Marketed |
| Aug 23, 2024 | Acetaminophen And IbuprofenANDA 218247 | Dr Reddys | 0 | Marketed |
| Jan 17, 2025 | Acetaminophen And IbuprofenANDA 217241 | Strides Pharma | 0 | Discontinued |
| Dec 11, 2025 | Acetaminophen And IbuprofenANDA 220126 | Lnk Intl Inc | 0 | Marketed |
| Jan 2, 2026 | Acetaminophen And IbuprofenANDA 219053 | Taro | 0 | Marketed |
| Nov 6, 2020 | Combogesic (acetaminophen and ibuprofen)Facility Inspections | Approved |
| Dec 22, 2017 | NDA 209471Clinical, Statistical, Nonclinical | 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; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Strides Pharma
Taro