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		2026-10-27
excluded package	package	0363-0533	0363-0533-25	D	Discontinued by firm		2026-10-27

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 101 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b	2025-09-17	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories Inc	3effaf4b-28c3-6131-e063-6294a90a17ff	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	1872e1ff-2e08-c404-e063-6294a90afa14	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1323a67c-b9c5-038c-e063-6394a90a5e6b	2025-09-17	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f025ef6-79e7-e833-e063-6294a90ab501	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	186f8519-655d-bd21-e063-6294a90a16a8	2025-09-17	Warnings	Exact identifier application number: M012
AXIV NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	131f6314-c9a1-7af3-e063-6294a90abe6f	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - NightTime 48 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	1320e243-344f-98ed-e063-6294a90a0092	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE	VIVUNT PHARMA LLC	13245298-8b78-e177-e063-6294a90a6bec	2025-09-17	Warnings	Exact identifier application number: M012
GoodSense Tussin CF Multi-Symptom Cold, Raspberry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	3f05cf84-d485-7688-e063-6394a90ae740	2025-09-17	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	5d7466b4-fdb7-432b-880d-e7aa4a4acbda	2025-09-17	Warnings	Exact identifier application number: M012
allergy relief Childrens	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	e34d8bf5-e12e-453c-93ea-9c7988c4f13d	2025-09-16	Warnings	Exact identifier application number: M012
DayTime Cold Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f	2025-09-16	Warnings	Exact identifier application number: M012
DOMETUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Domel Laboratories	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	2025-09-16	Warnings	Exact identifier application number: M012
CareOne Severe Congestion Nasal	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	d1dba68b-c4e1-4afc-9aee-6a51341b89f5	2025-09-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	e69ef8dc-09d2-46de-aebf-ba735f4cc7ea	2025-09-16	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3ea9a1f2-75b3-c67a-e063-6294a90a8caf	2025-09-13	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3eab4cf9-6fdc-a6fb-e063-6394a90a8633	2025-09-13	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	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