Mucinex DM — Tablet, Extended Release

Overview

Brand name

Mucinex DM

Generic name

Guaifenesin and Dextromethorphan Hydrobromide

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

NDA · NDA

Labeler

A-S Medication Solutions

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

4

NDC product codes

9

Packages

24

Data completeness

83% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Dextromethorphan Hydrobromide	30 mg/1	1094538	View
Dextromethorphan Hydrobromide	60 mg/1	1094538	View
Guaifenesin	1200 mg/1	359601	View
Guaifenesin	600 mg/1	359601	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Extended Release

Route of administration

Oral

Presentations

33

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Decreased Respiratory Secretion Viscosity [PE]	PE	All 52 members
Expectorant [EPC]	EPC	All 48 members
Increased Respiratory Secretions [PE]	PE	All 48 members
Sigma-1 Agonist [EPC]	EPC	All 44 members
Sigma-1 Receptor Agonists [MoA]	MoA	All 44 members
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]	EPC	All 44 members
Uncompetitive NMDA Receptor Antagonists [MoA]	MoA	All 44 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

021620

Application type

NDA · New Drug Application

Approval date

April 29, 2004

Sponsor

RECKITT BENCKISER

Products on application

2

Submissions recorded

14

Products approved under application 021620.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
021620-001	MUCINEX DM	TABLET, EXTENDED RELEASE		DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	Over-the-counter	—	RLD RS
021620-002	MUCINEX DM	TABLET, EXTENDED RELEASE		DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	Over-the-counter	—	RLD

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 021620.
Type	No.	Action	Status	Date	Review
Supplement	45	Labeling	Approved	August 6, 2024	Standard
Supplement	43	Labeling	Approved	February 19, 2021	Standard
Supplement	40	Manufacturing (CMC)	Approved	January 31, 2020	N/A
Supplement	39	Manufacturing (CMC)	Approved	January 3, 2019	N/A
Supplement	38	Manufacturing (CMC)	Approved	July 13, 2017	Standard
Supplement	37	Manufacturing (CMC)	Approved	April 7, 2015	Standard
Supplement	36	Manufacturing (CMC)	Approved	September 5, 2014	Standard
Supplement	31	Manufacturing (CMC)	Approved	May 12, 2011	Standard
Supplement	29	Manufacturing (CMC)	Approved	March 11, 2011	Standard
Supplement	21	Manufacturing (CMC)	Approved	April 3, 2009	N/A
Supplement	11	Manufacturing (CMC)	Approved	September 6, 2007	N/A
Supplement	5	Manufacturing (CMC)	Approved	January 26, 2006	Standard
Supplement	1	Manufacturing (CMC)	Approved	January 24, 2005	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	April 29, 2004	Standard

Review documents

0 · Supplement · August 8, 2024
0 · Supplement · August 8, 2024
0 · Supplement · February 23, 2021
0 · Supplement · February 23, 2021
0 · Supplement · August 13, 2020
0 · Supplement · February 1, 2019
0 · Supplement · December 4, 2017
0 · Supplement · December 1, 2017
0 · Supplement · March 7, 2014
0 · Supplement · March 7, 2014
0 · Supplement · April 9, 2009
0 · Supplement · September 7, 2007
0 · Supplement · September 7, 2007
0 · Supplement · January 30, 2006
0 · Original application · October 6, 2005
0 · Supplement · January 26, 2005
0 · Original application · May 4, 2004
0 · Original application · May 3, 2004

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260527). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260527 HUMAN OTC DRUG · 20260226 HUMAN OTC DRUG · 20230727 HUMAN OTC DRUG · 20230316

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Active ingredients (in each extended-release bi-layer tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant

Dosage and Administration

openFDA Drug Labeling

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours children under 12 years of age: do not use

Warnings

openFDA Drug Labeling

Warnings Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg Active ingredients (in each extended-release tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6549 NDC: 50090-6549-0 14 TABLET, EXTENDED RELEASE in a BLISTER PACK / 24 in a CARTON

Adverse event reports

Source: openFDA FAERS

202,963

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: GUAIFENESIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class III	April 29, 2015	Reckitt Benckiser LLC	Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch	Terminated

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-1077-0	50090-1077	A-S Medication Solutions	1 BLISTER PACK in 1 CARTON (50090-1077-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	November 28, 2014
50090-1078-0	50090-1078	A-S Medication Solutions	2 BLISTER PACK in 1 CARTON (50090-1078-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	November 28, 2014
50090-6549-0	50090-6549	A-S Medication Solutions	24 BLISTER PACK in 1 CARTON (50090-6549-0) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	July 11, 2023
66715-9724-1	66715-9724	Lil' Drug Store Products, Inc.	1 POUCH in 1 CARTON (66715-9724-1) / 2 TABLET, EXTENDED RELEASE in 1 POUCH	May 10, 2010
67751-171-01	67751-171	Navajo Manufacturing Company Inc.	1 POUCH in 1 CARTON (67751-171-01) / 2 TABLET, EXTENDED RELEASE in 1 POUCH	September 23, 2016
63824-056-32	63824-056	Reckitt Benckiser LLC	1 BLISTER PACK in 1 CARTON (63824-056-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-056-34	63824-056	Reckitt Benckiser LLC	2 BLISTER PACK in 1 CARTON (63824-056-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-056-36	63824-056	Reckitt Benckiser LLC	1 BLISTER PACK in 1 CARTON (63824-056-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-056-69	63824-056	Reckitt Benckiser LLC	3 BLISTER PACK in 1 CARTON (63824-056-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-056-72	63824-056	Reckitt Benckiser LLC	2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)	June 26, 2012
63824-056-74	63824-056	Reckitt Benckiser LLC	24 POUCH in 1 CARTON (63824-056-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73)	June 26, 2012
63824-056-80	63824-056	Reckitt Benckiser LLC	2 BLISTER PACK in 1 CARTON (63824-056-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	May 1, 2024
63824-072-02	63824-072	Reckitt Benckiser LLC	1 POUCH in 1 CARTON (63824-072-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH	August 1, 2021
63824-072-07	63824-072	Reckitt Benckiser LLC	1 BLISTER PACK in 1 CARTON (63824-072-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-072-35	63824-072	Reckitt Benckiser LLC	1 BLISTER PACK in 1 CARTON (63824-072-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-072-36	63824-072	Reckitt Benckiser LLC	2 BLISTER PACK in 1 CARTON (63824-072-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-072-46	63824-072	Reckitt Benckiser LLC	3 BLISTER PACK in 1 CARTON (63824-072-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-072-48	63824-072	Reckitt Benckiser LLC	4 BLISTER PACK in 1 CARTON (63824-072-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	June 26, 2012
63824-072-56	63824-072	Reckitt Benckiser LLC	4 BLISTER PACK in 1 CARTON (63824-072-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	July 1, 2021
85237-1650-1	85237-1650	Select Consumer Group	2 TABLET, EXTENDED RELEASE in 1 POUCH (85237-1650-1)	December 27, 2025
85237-1650-3	85237-1650	Select Consumer Group	20 POUCH in 1 CARTON (85237-1650-3) / 2 TABLET, EXTENDED RELEASE in 1 POUCH	December 24, 2025
85766-176-20	85766-176	Sportpharm LLC	1 BLISTER PACK in 1 CARTON (85766-176-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	February 27, 2026
85766-176-40	85766-176	Sportpharm LLC	2 BLISTER PACK in 1 CARTON (85766-176-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	February 27, 2026
85766-176-60	85766-176	Sportpharm LLC	3 BLISTER PACK in 1 CARTON (85766-176-60) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	February 27, 2026
50090-1077	50090-1077	A-S Medication Solutions	—	June 26, 2012
50090-1078	50090-1078	A-S Medication Solutions	—	June 26, 2012
50090-6549	50090-6549	A-S Medication Solutions	—	June 26, 2012
66715-9724	66715-9724	Lil' Drug Store Products, Inc.	—	May 10, 2010
67751-171	67751-171	Navajo Manufacturing Company Inc.	—	September 23, 2016
63824-056	63824-056	Reckitt Benckiser LLC	—	June 26, 2012
63824-072	63824-072	Reckitt Benckiser LLC	—	June 26, 2012
85237-1650	85237-1650	Select Consumer Group	—	June 26, 2012
85766-176	85766-176	Sportpharm LLC	—	June 26, 2012

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts
Enforcement	FDA	Recall records

Generated September 25, 2026 · 12 sections on this page.