Advil Cold And Sinus

NDA 19771, held by Haleon US Holdings. Ibuprofen; Pseudoephedrine Hydrochloride.

As of Nov 14, 2026, NDA 19771 (Advil Cold And Sinus), held by Haleon US Holdings, was first approved by FDA on Sep 19, 1989, with 23 approved supplements and 0 published complete response letters.

First approved: Sep 19, 1989
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

USES temporarily relieves these symptoms associated with the common cold or flu:

headache
fever
sinus pressure
nasal congestion
minor body aches and pains

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Sep 19, 1989	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Advil Cold And Sinus200MG;30MG · tablet;oral	Ibuprofen; Pseudoephedrine Hydrochloride	OTCReference drug

All 24 submissions, including labeling and manufacturing supplements


Nov 19, 2021	Supplement 45Labeling · Standard review	Approved	Letter Label
Mar 23, 2017	Supplement 40Labeling · Standard review	Approved	Letter Label
Sep 2, 2010	Supplement 36Labeling	Approved	Letter
May 19, 2009	Supplement 32Labeling · Standard review	Approved	Letter
Jun 20, 2008	Supplement 31Labeling · Standard review	Approved	Letter
Apr 17, 2006	Supplement 26Labeling · Standard review	Approved	Letter
Feb 23, 2006	Supplement 28Labeling · Standard review	Approved	Letter
Oct 17, 2003	Supplement 22Labeling · Standard review	Approved	Letter
Aug 2, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
May 23, 2001	Supplement 20Labeling · Standard review	Approved	Label
May 14, 2001	Supplement 18Labeling · Standard review	Approved	None posted
Jan 18, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 28, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 31, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 1, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 3, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 15, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 13, 1994	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 21, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 11, 1994	Supplement 8Labeling · Standard review	Approved	None posted
May 28, 1992	Supplement 4Labeling	Approved	None posted
Sep 4, 1991	Supplement 7Labeling	Approved	None posted
Oct 17, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 19, 1989	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 19771
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