Mucinex Dm

NDA 21620, held by Reckitt Benckiser. Dextromethorphan Hydrobromide; Guaifenesin.

As of Nov 15, 2026, NDA 21620 (Mucinex Dm), held by Reckitt Benckiser, was first approved by FDA on Apr 29, 2004, with 13 approved supplements and 0 published complete response letters.

First approved: Apr 29, 2004
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Apr 29, 2004	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Mucinex Dm60MG;1.2GM · tablet, extended release;oral	Dextromethorphan Hydrobromide; Guaifenesin	OTCReference drug
Mucinex Dm30MG;600MG · tablet, extended release;oral	Dextromethorphan Hydrobromide; Guaifenesin	OTCReference drug

All 14 submissions, including labeling and manufacturing supplements


Aug 6, 2024	Supplement 45Labeling · Standard review	Approved	Letter Label
Feb 19, 2021	Supplement 43Labeling · Standard review	Approved	Label Letter
Jan 31, 2020	Supplement 40Manufacturing	Approved	Letter
Jan 3, 2019	Supplement 39Manufacturing	Approved	Letter
Jul 13, 2017	Supplement 38Manufacturing · Standard review	Approved	Label Letter
Apr 7, 2015	Supplement 37Manufacturing · Standard review	Approved	None posted
Sep 5, 2014	Supplement 36Manufacturing · Standard review	Approved	None posted
May 12, 2011	Supplement 31Manufacturing · Standard review	Approved	Letter
Mar 11, 2011	Supplement 29Manufacturing · Standard review	Approved	Letter
Apr 3, 2009	Supplement 21Manufacturing	Approved	Letter
Sep 6, 2007	Supplement 11Manufacturing	Approved	Letter Label
Jan 26, 2006	Supplement 5Manufacturing · Standard review	Approved	Letter
Jan 24, 2005	Supplement 1Manufacturing · Standard review	Approved	Letter
Apr 29, 2004	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21620
Drugs@FDA: Overview at FDA
Company: Reckitt Benckiser LLC

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