Children'S Advil Cold

NDA 21373, held by Haleon US Holdings. Ibuprofen; Pseudoephedrine Hydrochloride.

As of Nov 14, 2026, NDA 21373 (Children'S Advil Cold), held by Haleon US Holdings, was first approved by FDA on Apr 18, 2002, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 18, 2002
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 18, 2002	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Children'S Advil Cold100MG/5ML;15MG/5ML · suspension;oral	Ibuprofen; Pseudoephedrine Hydrochloride	OTC

All 9 submissions, including labeling and manufacturing supplements


Mar 24, 2017	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 7, 2012	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 24, 2010	Supplement 11Labeling	Approved	Letter
May 19, 2009	Supplement 9Labeling · Standard review	Approved	Letter
Dec 3, 2008	Supplement 8Labeling · Standard review	Approved	Letter
Apr 4, 2006	Supplement 5Labeling · Standard review	Approved	Letter
Jan 12, 2005	Supplement 3Labeling · Standard review	Approved	Letter
Mar 25, 2003	Supplement 1Labeling · Standard review	Approved	Letter
Apr 18, 2002	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 21373
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