Mucinex D

NDA 21585, held by Reckitt Benckiser. Guaifenesin; Pseudoephedrine Hydrochloride.

As of Nov 15, 2026, NDA 21585 (Mucinex D), held by Reckitt Benckiser, was first approved by FDA on Jun 22, 2004, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2004
Review: Standard
Supplements approved: 9
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 nasal congestion due to:
common cold
hay fever
upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jun 22, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Mucinex D600MG;60MG · tablet, extended release;oral	Guaifenesin; Pseudoephedrine Hydrochloride	OTCReference drug
Mucinex D1.2GM;120MG · tablet, extended release;oral	Guaifenesin; Pseudoephedrine Hydrochloride	OTCReference drug

All 10 submissions, including labeling and manufacturing supplements


Jul 8, 2024	Supplement 38Labeling · Standard review	Approved	Label Letter
Jul 13, 2017	Supplement 33Manufacturing · Standard review	Approved	Label Letter
May 22, 2014	Supplement 30Manufacturing	Approved	Letter
Aug 2, 2013	Supplement 29Manufacturing · Standard review	Approved	None posted
May 12, 2011	Supplement 26Manufacturing · Standard review	Approved	Letter
Dec 20, 2010	Supplement 25Manufacturing · Standard review	Approved	Letter
Sep 6, 2007	Supplement 12Manufacturing	Approved	Letter Label
Feb 23, 2005	Supplement 1Manufacturing · Standard review	Approved	Letter
Jan 24, 2005	Supplement 2Manufacturing · Standard review	Approved	Letter
Jun 22, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21585
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