MUCOSA

Product NDC: 49483-272
11-digit product format: 494830272
Labeler code: 49483
Product ID: 49483-272_092526a7-c2e1-4cb5-e063-6394a90ac509
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET
Route: ORAL
Labeler: TIME CAP LABORATORIES,INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-04-16
Substance: GUAIFENESIN
Active strength: 400 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: MUCOSA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
359601	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
d34ef2e8-adc2-48e5-a572-e354937daec6	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
49483-272-00	MUCOSA	100000 in 1 CARTON	TABLET	100000	5
49483-272-06	MUCOSA	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
49483-272-20	MUCOSA	200 in 1 BOTTLE	TABLET	200	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-272-06	EA - Each	49483-272	58558786-c85e-40fc-96a2-3b3579028fcd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
Povidones	INACTIVE INGREDIENT	FZ989GH94E	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCOSA (GUAIFENESIN) TABLET [AVPAK]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-272	MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]	5	Current NDC, Legacy NDC, 3 package rows	20231102_d34ef2e8-adc2-48e5-a572-e354937daec6.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 28 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7354f57c-0ecf-481f-9482-0040c90c4350	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE	Reckitt Benckiser LLC	e3aea6df-37a4-43c5-a192-a902cbff3f92	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	Reckitt Benckiser LLC	c7ab5201-8550-4bf4-957c-c8f049aeaa4a	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	771d7fd8-184f-48a3-90ed-e8f00159d97e	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX Childrens Stuffy Nose	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	de1c0abd-1644-4351-8106-e9df6ca5c142	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	19105007-0193-0764-e063-6294a90a01a4	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	34fd2458-9acd-cdf7-e063-6394a90a3d0a	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3a24b06c-00a6-c2ef-e063-6294a90a4d72	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	14be3ab0-d6ae-e342-e063-6294a90ab851	2026-05-18	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	d34ef2e8-adc2-48e5-a572-e354937daec6	5
359601	guaifenesin 400 MG Oral Tablet	SCD	d34ef2e8-adc2-48e5-a572-e354937daec6	5
359601	guaiFENesin 400 MG Oral Tablet	PSN	33f9c655-87f5-4cbb-889f-fbb3f376b09d	4
359601	guaifenesin 400 MG Oral Tablet	SCD	33f9c655-87f5-4cbb-889f-fbb3f376b09d	4
359601	guaiFENesin 400 MG Oral Tablet	PSN	73f68f97-ad3a-492b-a96d-304b464ffd03	1
359601	guaifenesin 400 MG Oral Tablet	SCD	73f68f97-ad3a-492b-a96d-304b464ffd03	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-272-00	49483027200	100000 TABLET in 1 CARTON (49483-272-00)	100000 tablet	2012-04-16	0000-00-00	No	No	Current
49483-272-06	49483027206	60 TABLET in 1 BOTTLE, PLASTIC (49483-272-06)	60 tablet	2012-04-16	0000-00-00	No	No	Current
49483-272-20	49483027220	200 TABLET in 1 BOTTLE (49483-272-20)	200 tablet	2023-09-15		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
272R Timely 49483-272 Guaifenesin 400 mg Tablets	TIME CAP LABORATORIES,INC	2023-11-02	HUMAN OTC DRUG LABEL	5
major 272R	Major Pharmaceuticals \| TIME CAP LABORATORIES, INC	2019-12-04	HUMAN OTC DRUG LABEL	5
Guaifenesin (Product contract packaged by Apace Packaging, LLC)	Apace Packaging, LLC \| Time Cap Laboratories, Inc.	2018-11-20	HUMAN OTC DRUG LABEL	2
Guaifenesin	AvPAK	2018-06-07	HUMAN OTC DRUG LABEL	3
MUCOSA - Unit Dose Services	Unit Dose Services	2017-07-19	HUMAN OTC DRUG LABEL	4
Mucus Relief 400mg	Clinical Solutions Wholesale	2013-11-20	HUMAN OTC DRUG LABEL	1