Mucinex

NDA 21282, held by Reckitt Benckiser. Guaifenesin.

As of Nov 14, 2026, NDA 21282 (Mucinex), held by Reckitt Benckiser, was first approved by FDA on Jul 12, 2002, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2002
Review: Standard
Supplements approved: 18
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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jul 12, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Mucinex600MG · tablet, extended release;oral	Guaifenesin	OTCReference drug
Mucinex1.2GM · tablet, extended release;oral	Guaifenesin	OTCReference drug

All 19 submissions, including labeling and manufacturing supplements


Aug 30, 2024	Supplement 55Labeling · Standard review	Approved	Label Letter
Feb 19, 2021	Supplement 54Labeling · Standard review	Approved	Label Letter
Apr 2, 2020	Supplement 51Manufacturing	Approved	Letter
Oct 27, 2017	Supplement 49Manufacturing	Approved	Label
Jul 3, 2017	Supplement 48Manufacturing · Standard review	Approved	Label Letter
Oct 19, 2015	Supplement 46Manufacturing · Standard review	Approved	Letter
Mar 9, 2015	Supplement 45Manufacturing · Standard review	Approved	Letter
Sep 10, 2014	Supplement 44Manufacturing · Standard review	Approved	Letter
May 22, 2014	Supplement 43Manufacturing · Standard review	Approved	Letter
May 12, 2011	Supplement 37Manufacturing · Standard review	Approved	Letter
Mar 11, 2011	Supplement 35Manufacturing · Standard review	Approved	Letter
Nov 24, 2009	Supplement 31Manufacturing	Approved	Label Letter
Apr 3, 2009	Supplement 29Manufacturing · Standard review	Approved	Letter
Aug 20, 2008	Supplement 25Manufacturing	Approved	Letter
Sep 6, 2007	Supplement 21Manufacturing	Approved	Letter Label
Nov 14, 2006	Supplement 16Labeling · Standard review	Approved	Letter
Aug 23, 2006	Supplement 11Manufacturing	Approved	Letter
Dec 18, 2002	Supplement 1Manufacturing · Standard review	Approved	Letter
Jul 12, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21282
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