MUCOSA DM

Product NDC: 49483-280
Requested package NDC: 49483-280-00
11-digit product format: 494830280
Labeler code: 49483
Product ID: 49483-280_2d9cef2f-22cd-ed8e-e063-6394a90ad8a8
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN DEXTROMETHORPHAN
Dosage form: TABLET
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-04-17
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: 2026-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	Warnings	Exact identifier application number: M012

Additional Listing Data#

Finished product: Yes
Brand name base: MUCOSA DM
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
9D2RTI9KYH	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
62c1f4aa-6571-414c-9a58-31e107b7db97	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49483-280-00	2025-02-10	C162847	48780-1	2cef2736-9887-d83d-e063-dadaa90ab31f	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-06	2025-02-10	C162847	48780-1	2cef2736-9887-d83d-e063-dadaa90ab31f	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-20	2025-02-10	C162847	48780-1	2cef2736-9887-d83d-e063-dadaa90ab31f	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-00	2025-01-30	C162847	48780-1	2cef2736-9887-d83d-e063-dadaa90ab31f	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-06	2025-01-30	C162847	48780-1	2cef2736-9887-d83d-e063-dadaa90ab31f	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-20	2025-01-30	C162847	48780-1	2cef2736-9887-d83d-e063-dadaa90ab31f	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-280-00	MUCOSA DM	100000 in 1 CARTON	TABLET	100000	4
49483-280-06	MUCOSA DM	60 in 1 BOTTLE, PLASTIC	TABLET	60	4
49483-280-20	MUCOSA DM	200 in 1 BOTTLE	TABLET	200	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-280-06	EA - Each	49483-280	b93edcce-7cd8-4ba1-886f-a2dfc6db3b3c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]	1000
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-280	MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN) TABLET [TIME CAP LABORATORIES, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250212_62c1f4aa-6571-414c-9a58-31e107b7db97.zip

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	62c1f4aa-6571-414c-9a58-31e107b7db97	4
1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD	62c1f4aa-6571-414c-9a58-31e107b7db97	4
1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY	62c1f4aa-6571-414c-9a58-31e107b7db97	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-280-00	49483028000	100000 TABLET in 1 CARTON (49483-280-00)	100000 tablet	2018-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets	TIME CAP LABORATORIES, INC.	2025-02-08	HUMAN OTC DRUG LABEL	4
MUCUS RELIEF DM - MAJOR PHARMACEUTICALS INC \| TIME CAP LABORATORIES, INC	MAJOR PHARMACEUTICALS INC \| TIME CAP LABORATORIES, INC	2019-10-07	HUMAN OTC DRUG LABEL	2
IBU ® Tablets	Bryant Ranch Prepack	2014-06-13	HUMAN OTC DRUG LABEL	1000