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		2026-10-21

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 117 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	87ebb4d9-78d7-1c87-e053-2a95a90adb7d	2025-03-27	Warnings	Exact identifier application number: M012
REVASOL CHILDRENS ALLERGY	DIPHENHYDRAMINE HCL	Rnv LLC	3143137f-ef42-5358-e063-6394a90a8ed1	2025-03-26	Warnings	Exact identifier application number: M012
Rompe Pecho SF FLU	DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Efficient Laboratories Inc	bc10695a-9664-4ce3-82bb-820da06129fa	2025-03-26	Warnings	Exact identifier application number: M012
SUPRESS-PE Pediatric	GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	a474171d-5c29-4a80-9d37-00613796211a	2025-03-26	Warnings	Exact identifier application number: M012
Guaifenesin DM	DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN	Innovida Pharmaeutique Corporation	dd3f806b-2470-4055-94e1-18adac811025	2025-03-25	Warnings	Exact identifier application number: M012
Foster and Thrive childrens cold cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	38b710e3-1d01-4ff4-a6b6-44936f277f49	2025-03-25	Warnings	Exact identifier application number: M012
Revasol Tussin DM Max with Honey	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Rnv LLC	30da9255-c93a-84d6-e063-6394a90a7c2a	2025-03-21	Warnings	Exact identifier application number: M012
REVASOL NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Rnv LLC	30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9	2025-03-21	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Exact identifier application number: M012
Rompe Tos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cc932d-b412-0710-e063-6394a90a87f6	2025-03-19	Warnings	Exact identifier application number: M012
Rompe Tos X Adults	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05abb2db-d22e-90b5-e063-6294a90ace3f	2025-03-19	Warnings	Exact identifier application number: M012
Sinus Head Congestion	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	30a07773-bd6f-b9f2-e063-6394a90ab8aa	2025-03-18	Warnings	Exact identifier application number: M012
Halls Sugar Free Black Cherry	MENTHOL	Mondelez Global LLC	bd2a311a-bf0c-4365-af9b-76675c243b22	2025-03-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	TARGET CORPORATION	fbca9627-5e12-048a-e053-6294a90a6e0f	2025-03-15	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	DOLGENCORP, INC.	0655688e-7c42-507f-e063-6294a90ae498	2025-03-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	1b8d5494-1fcf-4cd0-acc0-34f17d577bd7	2025-03-14	Warnings	Exact identifier application number: M012
Ultra Concentrated Daytime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	300b2357-933b-fe9a-e063-6294a90aa4b9	2025-03-11	Warnings	Exact identifier application number: M012
Ultra Concentrated Nighttime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	PuraCap Pharmaceutical LLC	300bf27f-744f-7366-e063-6394a90acbcb	2025-03-11	Warnings	Exact identifier application number: M012
Daytime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	300c7c7b-ea0b-3650-e063-6294a90a65e8	2025-03-11	Warnings	Exact identifier application number: M012
Rompe Pecho Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	EFFICIENT LABORATORIES INC	2ec319a8-92bf-4552-86dd-37cbce18980f	2025-03-11	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