Pediatric Advil, Infant'S Advil

NDA 20812, held by Haleon US Holdings. Ibuprofen.

As of Nov 14, 2026, NDA 20812 (Pediatric Advil, Infant'S Advil), held by Haleon US Holdings, was first approved by FDA on Jan 30, 1998, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1998
Review: Standard
Supplements approved: 19
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, headaches and toothaches

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Jan 12, 2000	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label
Jan 30, 1998	Original applicationNew dosage form · Standard review	Approved	Review

Products

2 strengths and forms


Pediatric Advil100MG/2.5ML · suspension/drops;oral	Ibuprofen	DiscontinuedReference drug
Infant'S Advil50MG/1.25ML · suspension/drops;oral	Ibuprofen	OTCReference drug

All 20 submissions, including labeling and manufacturing supplements


Jul 6, 2017	Supplement 24Labeling · Standard review	Approved	Letter Label
Mar 24, 2017	Supplement 23Labeling · Standard review	Approved	Label Letter
Feb 26, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 11, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 6, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 24, 2013	Supplement 19Manufacturing · Standard review	Approved	Label Letter
Apr 26, 2011	Supplement 17Labeling	Approved	Letter
May 19, 2009	Supplement 15Labeling · Standard review	Approved	Letter
Jun 11, 2008	Supplement 14Labeling · Standard review	Approved	Letter
Apr 4, 2006	Supplement 12Labeling · Standard review	Approved	Letter
Sep 10, 2004	Supplement 11Labeling · Standard review	Approved	Review Letter
Jun 28, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 2, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 7, 2000	Supplement 7Labeling · Standard review	Approved	Review
Feb 10, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 12, 2000	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label
Oct 14, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 19, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
May 19, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 30, 1998	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20812
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