Relieves occasional sleeplessness. NDA 21394, held by Haleon US Holdings. Diphenhydramine Citrate; Ibuprofen.
As of Nov 14, 2026, NDA 21394 (Advil Pm), held by Haleon US Holdings, was first approved by FDA on Dec 21, 2005, with 13 approved supplements and 0 published complete response letters.
Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2005 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Advil Pm38MG;200MG · tablet;oral | Diphenhydramine Citrate; Ibuprofen | OTCReference drug |
| Feb 21, 2023 | Supplement 33Labeling · Standard review | Approved | |
| Jan 10, 2022 | Supplement 32Labeling · Standard review | Approved | |
| Oct 2, 2018 | Supplement 26Labeling · Standard review | Approved | |
| Apr 18, 2018 | Supplement 25Labeling · Standard review | Approved | |
| Jul 21, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Mar 30, 2017 | Supplement 21Labeling · Standard review | Approved | |
| Mar 15, 2016 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 7, 2015 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jan 5, 2015 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 25, 2011 | Supplement 14Labeling · Standard review | Approved | |
| Sep 1, 2010 | Supplement 15Labeling · Standard review | Approved | |
| May 19, 2009 | Supplement 12Labeling · Standard review | Approved | |
| Jun 11, 2008 | Supplement 10Labeling · Standard review | Approved | |
| Dec 21, 2005 | 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
