NDA 211733, held by Haleon US Holdings. Acetaminophen; Ibuprofen.
As of Nov 13, 2026, NDA 211733 (Advil Dual Action With Acetaminophen), held by Haleon US Holdings, was first approved by FDA on Feb 28, 2020, with 3 approved supplements and 0 published complete response letters.
Uses Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2020 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Advil Dual Action With Acetaminophen250MG;125MG · tablet;oral | Acetaminophen; Ibuprofen | OTCReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jan 25, 2022 | Supplement 4Labeling · Standard review | Approved | |
| Jan 10, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Feb 28, 2020 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
