Children'S Advil, Children'S Advil-Flavored

NDA 20589, held by Haleon US Holdings. Ibuprofen.

As of Nov 13, 2026, NDA 20589 (Children'S Advil, Children'S Advil-Flavored), held by Haleon US Holdings, was first approved by FDA on Jun 27, 1996, with 27 approved supplements and 0 published complete response letters.

First approved: Jun 27, 1996
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

USES temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Jun 27, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Products

2 strengths and forms


Children'S Advil100MG/5ML · suspension;oral	Ibuprofen	OTC
Children'S Advil-Flavored100MG/5ML · suspension;oral	Ibuprofen	OTC

All 28 submissions, including labeling and manufacturing supplements


Jun 26, 2026	Supplement 44Labeling · Standard review	Approved	Letter Label
May 1, 2026	Supplement 43Labeling · Standard review	Approved	Letter
Sep 20, 2022	Supplement 39Manufacturing	Approved	Letter Label
Aug 30, 2018	Supplement 37Labeling · Standard review	Approved	Label
Jun 21, 2017	Supplement 35Labeling · Standard review	Approved	Label Letter
Mar 23, 2017	Supplement 34Labeling · Standard review	Approved	Letter Label
Jul 28, 2016	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 20, 2013	Supplement 29Manufacturing · Standard review	Approved	Label Letter
Jun 12, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 7, 2012	Supplement 31Manufacturing · Standard review	Approved	None posted
Sep 4, 2012	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 2, 2010	Supplement 26Labeling · Standard review	Approved	Letter
May 19, 2009	Supplement 24Labeling · Standard review	Approved	Letter
Jun 11, 2008	Supplement 23Labeling · Standard review	Approved	Letter
Dec 7, 2005	Supplement 19Labeling · Standard review	Approved	Letter
Mar 18, 2005	Supplement 17Labeling · Standard review	Approved	Letter Label
Nov 14, 2002	Supplement 15Labeling · Standard review	Approved	None posted
Sep 17, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 2, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 2, 2001	Supplement 13Manufacturing · Standard review	Approved	Label
Aug 25, 2000	Supplement 9Labeling · Standard review	Approved	None posted
Jul 14, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 30, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 17, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 14, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
May 5, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 7, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 27, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Identifiers

Application: NDA 20589
Drugs@FDA: Overview at FDA
Company: Haleon US Holdings

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