Mucus Relief

Product NDC: 76162-004
Requested package NDC: 76162-004-01
11-digit product format: 761620004
Labeler code: 76162
Product ID: 76162-004_bf64ce65-6978-4634-bd02-ab1389acf47d
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin 400mg
Dosage form: TABLET
Route: ORAL
Labeler: TopCo Associates, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-23
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: Mucus Relief
Brand name suffix: Immediate Release
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
7d91c6ab-d161-42b9-b353-0aa8f59619f8	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
76162-004-01	Mucus ReliefImmediate Release	100 in 1 BOTTLE	TABLET	100	7
76162-004-81	Mucus ReliefImmediate Release	2 in 1 CARTON	TABLET	2	7
76162-004-81	Mucus ReliefImmediate Release	200 in 1 BOTTLE	TABLET	200	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-004	MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN 400MG) TABLET [TOPCO ASSOCIATES, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20231108_7d91c6ab-d161-42b9-b353-0aa8f59619f8.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 89 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Complete	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	15b3de6c-7ccc-408b-8789-d0e2f21a8835	2025-11-12	Warnings	Exact identifier application number: M012
PRESGEN PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE	KRAMER NOVIS	12fb91e5-6059-4b3a-a2de-762aa51a25b7	2025-11-12	Warnings	Exact identifier application number: M012
Sorbugen	DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE	Kramer Novis	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	2025-11-12	Warnings	Exact identifier application number: M012
DESGEN DM	DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL	Kramer Novis	6ab47174-e1fd-47ce-8788-06b7cdad5218	2025-11-12	Warnings	Exact identifier application number: M012
Presgen	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Kramer Novis	edad7a86-0d27-4a98-85b2-4b6725904f28	2025-11-12	Warnings	Exact identifier application number: M012
TUSICOF	DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE	Kramer Novis	e966b75c-4bb4-4216-8247-baada8f5d759	2025-11-12	Warnings	Exact identifier application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	52327ed0-ea49-4d1c-b928-20ab381be9f2	2025-11-11	Warnings	Exact identifier application number: M012
TOPCO Childrens Cough Relief	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Topco Associates, LLC	ee0f5627-5104-4990-88ee-2fb46965bc1e	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Childrens Cold and Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates, LLC	8931d4ca-c599-49be-87e1-8c0598f38b77	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	01c517e5-d693-4926-9eb5-4b894a2f6917	2025-11-11	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435b4a2a-d6bf-ec25-e063-6294a90a3f06	2025-11-11	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435e6387-1ee0-c20f-e063-6294a90adac5	2025-11-11	Warnings	Exact identifier application number: M012
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b	2025-11-10	Warnings	Exact identifier application number: M012
TOPCARE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	Topco Associates, LLC	b5e15dd1-6e99-411c-9183-8a4265eae404	2025-11-08	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	103de130-ef12-4c58-bbcf-234b3f3b2cbf	2025-11-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	2b3fbab9-92b5-42a7-b27b-ff46350ce055	2025-11-07	Warnings	Exact identifier application number: M012
Robitussin Day and Night Maximum Strength Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b43d8fbd-1977-4465-aa64-79e7b7f54e09	2025-11-07	Warnings	Exact identifier application number: M012
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	093649a4-f968-49bd-83af-bb7e0f448ecf	2025-11-07	Warnings	Exact identifier application number: M012
TARGET Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	bfc91c71-0506-4e94-8bfe-dc9e4bf959da	2025-11-07	Warnings	Exact identifier application number: M012
CHILDRENS COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	H E B	08f4785a-c628-4e9b-9412-b2a817f9be60	2025-11-07	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	7d91c6ab-d161-42b9-b353-0aa8f59619f8	7
359601	guaifenesin 400 MG Oral Tablet	SCD	7d91c6ab-d161-42b9-b353-0aa8f59619f8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76162-004-01	76162000401	100 TABLET in 1 BOTTLE (76162-004-01)	100 tablet	2014-12-23	0000-00-00	No	No	Current