MUCOSA DM

Product NDC: 49483-280
Requested package NDC: 49483-280-20
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-280	49483-280-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-280	49483-280-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-280	49483-280-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	20 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, Related label table
NDC	Effective	Related label
49483-280-00	2025-02-10	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-06	2025-02-10	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-20	2025-02-10	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-00	2025-01-30	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-06	2025-01-30	280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-20	2025-01-30	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

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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy Relief	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	d64fe757-9948-4727-b5dd-1f8e4e4763e2	2026-09-10	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	3856c1e4-814f-85c4-e063-6394a90ab8a8	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	f4328b44-cdfa-41aa-e053-2995a90a2728	2026-09-08	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	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	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	Sample	Exclude flag	Status
49483-280-20	49483028020	200 TABLET in 1 BOTTLE (49483-280-20)	200 tablet	2023-09-15	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