Advil Allergy And Congestion Relief, Advil Multi-Symptom Cold & Flu

NDA 22113, held by Haleon US Holdings. Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride.

As of Nov 13, 2026, NDA 22113 (Advil Allergy And Congestion Relief, Advil Multi-Symptom Cold & Flu), held by Haleon US Holdings, was first approved by FDA on Dec 21, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 21, 2011
Review: Standard
Supplements approved: 8
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 minor body aches and pains nasal congestion runny nose sinus pressure sneezing reduces swelling of the nasal passages temporarily restores freer breathing through the nose

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Apr 28, 2017	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 21, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter

Products

2 strengths and forms


Advil Allergy And Congestion Relief4MG;200MG;10MG · tablet;oral	Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride	OTCReference drug
Advil Multi-Symptom Cold & Flu4MG;200MG;10MG · tablet;oral	Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride	OTCReference drug

All 9 submissions, including labeling and manufacturing supplements


Nov 23, 2021	Supplement 11Labeling · Standard review	Approved	Label Letter
Sep 6, 2019	Supplement 8Labeling · Standard review	Approved	Label Letter
Jul 9, 2019	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 25, 2019	Supplement 5Labeling · Standard review	Approved	Letter Label
Feb 26, 2018	Supplement 4Labeling · Standard review	Approved	Label Letter
Feb 26, 2018	Supplement 3Labeling · Standard review	Approved	Label Letter
Apr 28, 2017	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 24, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Dec 21, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 22113
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