Mucus Relief DM

Product NDC: 0363-0533
11-digit product format: 003630533
Labeler code: 0363
Product ID: 0363-0533_4d721ae5-176b-419f-b29b-a6c138a656f7
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Walgreen Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-12-31
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 400 mg/1; mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-0533	0363-0533-11	D	Discontinued by firm		2026-10-21
excluded package	package	0363-0533	0363-0533-25	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 23 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0363-0533-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0533-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0533-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0533-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0533-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0533-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0533-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0533-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0533-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0533-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0533-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0533-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0533-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0533-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0533-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0533-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0533-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0533-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0533-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0533-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0533-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0533-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0533-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mucus Relief DM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/1
GUAIFENESIN	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1147685	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0533-01	Mucus Relief DM	1 in 1 CARTON	TABLET, FILM COATED	1	20
0363-0533-01	Mucus Relief DM	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	20
0363-0533-11	Mucus Relief DM	1 in 1 CARTON	TABLET, FILM COATED	1	20
0363-0533-11	Mucus Relief DM	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	20
0363-0533-25	Mucus Relief DM	1 in 1 CARTON	TABLET, FILM COATED	1	20
0363-0533-25	Mucus Relief DM	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	20
0363-0533-32	Mucus Relief DM	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	20
0363-0533-32	Mucus Relief DM	2 in 1 CARTON	TABLET, FILM COATED	2	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0533-01	EA - Each	0363-0533	cf265359-d038-4be1-b6b2-79f4b256d2f3	1	2015-04-03
0363-0533-11	EA - Each	0363-0533	4127c256-e923-41b2-9dcb-275131d05026	1	2015-04-03
0363-0533-25	EA - Each	0363-0533	5853103b-a2af-46dd-9a5b-5bc685885467	1	2017-11-06
0363-0533-32	EA - Each	0363-0533	adf468a2-38a4-4622-b10e-e902c4e2fefe	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0533	MUCUS RELIEF DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [WALGREEN COMPANY]	19	Current NDC, Legacy NDC, 8 package rows	20250510_cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 47 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	Warnings	Exact identifier application number: M012
NIGHTTIME CHERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	36924420-f514-4225-e063-6294a90a330c	2026-03-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS HEALTH CORP	4584d701-5a4e-e54e-e063-6394a90a38d6	2026-03-03	Warnings	Exact identifier application number: M012
foster and thrive nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Sportpharm LLC	7bdfd2ef-bb99-41f5-97ae-3a02c994bddd	2026-03-03	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	d27b5976-8cc0-4d99-96f6-9069b786affd	2026-03-03	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	A-S Medication Solutions	7f703c9c-2256-4524-9d31-c51919399d26	2026-03-03	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	f49f1e9a-07ac-443e-9df8-3281d5f35e78	2026-03-03	Warnings	Exact identifier application number: M012
berkley and jensen nasal	OXYMETAZOLINE HYDROCHLORIDE	BJWC	77cbe75d-4ed9-4a8b-91dc-1cc28af25508	2026-03-02	Warnings	Exact identifier application number: M012
childrens cold and cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Walgreen Company	6c7c950d-ed48-4428-9e9e-73684cabc699	2026-02-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Kroger Co.	116146db-719f-4c48-8a8a-1120ea62b0d5	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	1f737b76-14b5-618a-e063-6294a90a19c2	2026-02-27	Warnings	Exact identifier application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEF	DOXYLAMINE SUCCINATE	WALGREENS CO.	a3c7df98-4611-4b61-9c03-5e687364bf74	2026-02-27	Warnings	Exact identifier application number: M012
MEIJER Childrens Allergy Relief Chews	DIPHENHYDRAMINE HCL	MEIJER DISTRIBUTION INC	3368e081-a3b2-4c03-8bd1-05cc6af0391d	2026-02-27	Warnings	Exact identifier application number: M012
CVS PHARMACY Nighttime MS Flu Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	23cafaa1-34fe-4cef-960b-5f664ea32cb4	2026-02-27	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	402969c9-945c-44b7-b018-b62f427ce571	2026-02-26	Warnings	Exact identifier application number: M012
nasal original	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	d997f264-1b4a-4cca-a282-bd9645d55bfd	2026-02-26	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Fever Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	2a569e47-3f17-4fc7-83d6-a3dddfd4987e	2026-02-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	184059b7-9238-480e-be4a-ed105f13c19d	2026-02-25	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1147685	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet	PSN	cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa	20
1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD	cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa	20
1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY	cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0533-01	00363053301	1 BOTTLE, PLASTIC in 1 CARTON (0363-0533-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2005-12-31	0000-00-00	No	No	Current
0363-0533-11	00363053311	1 BOTTLE, PLASTIC in 1 CARTON (0363-0533-11) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2005-12-31	0000-00-00	No	No	Current
0363-0533-25	00363053325	1 BOTTLE in 1 CARTON (0363-0533-25) > 45 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2005-12-31	0000-00-00	No	No	Current
0363-0533-32	00363053332	2 BOTTLE, PLASTIC in 1 CARTON (0363-0533-32) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2005-12-31	0000-00-00	No	No	Current