Mucus Relief

Product NDC: 76162-004
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76162-004	76162-004-81	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
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 41 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Allergy	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DOLGENCORP, LLC	b55452e1-25d0-4db5-9621-83f21ec6c298	2026-04-06	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Strategic Sourcing Services LLC	c9fa8d93-d9d6-4206-a13d-32b9e7555e7f	2026-04-02	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	6aaed3fe-ce35-4533-aea4-80096ce8e57a	2026-04-02	Warnings	Exact identifier application number: M012
Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	19879fc8-4962-4c6e-87ed-b874d1d564af	2026-04-01	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Lidl US LLC	7227b330-590b-4731-8a58-e05a0233dd8a	2026-04-01	Warnings	Exact identifier application number: M012
SudoGest	CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	7cd8f7f3-c262-4f7c-bcaf-068be2c952f9	2026-04-01	Warnings	Exact identifier application number: M012
Sanatos Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	4c26be18-733a-e4a8-e063-6294a90a8b02	2026-04-01	Warnings	Exact identifier application number: M012
Sanatos Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	4c26c8bf-0143-ddca-e063-6294a90a3552	2026-04-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Method Pharmaceuticals, LLC	fe126254-6ee6-48c3-965c-96e4276a5314	2026-04-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief	GUAIFENESIN	AmerisourceBergen Drug Corp	200dddd9-e3ff-4cec-a164-d1c9a698f121	2026-03-31	Warnings	Exact identifier application number: M012
Head and Cold	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Hi-Tech Nutraceuticals, LLC	a39c772b-3cce-14cb-e053-2a95a90a733b	2026-03-31	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	44217a8c-7656-a0f6-e063-6294a90af2ad	2026-03-31	Warnings	Exact identifier application number: M012
Dr Kids Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	CalmCo LLC	3f156679-7a91-aff1-e063-6394a90a18f6	2026-03-31	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	A-S Medication Solutions	c26da6e0-ab1c-46c2-acf5-0074958c03cd	2026-03-31	Warnings	Exact identifier application number: M012
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Cardinal Health 110, LLC. DBA Leader	ba174fcc-da1e-420c-bf9c-179ad65c2848	2026-03-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Amerisource Bergen	8e0c6f8d-559c-45de-9362-1b713fd78a7a	2026-03-30	Warnings	Exact identifier application number: M012
Dr. Simi Daytime Cold and Flu	ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG	Farmacias De Similares TX LLC	4e448fd0-cb6b-b69b-e063-6394a90afde8	2026-03-30	Warnings	Exact identifier application number: M012
Dr. Simi Nighttime Cold and Flu	ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG	Farmacias De Similares TX LLC	4e5772ee-586c-6191-e063-6294a90a132d	2026-03-30	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HCL	HyVee Inc	75b19163-db1c-42fc-8bbb-364be16b9b2f	2026-03-30	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	a9f23c63-eeda-4de9-aec6-fe482f469e98	2026-03-27	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
76162-004-81	76162000481	2 BOTTLE in 1 CARTON (76162-004-81) > 200 TABLET in 1 BOTTLE	2 bottle	2014-12-23	2022-01-31	No	No	Current