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 13 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tukol Max Action Cold and Flu Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	cf0987a3-2c1d-4f40-8551-df9a8e08cd3d	2026-08-03	Warnings	Exact identifier application number: M012
Pressure, Pain and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	7d42e164-86e9-4baa-a389-3271cf99920e	2026-08-03	Warnings	Exact identifier application number: M012
DG Health Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp Inc	ed754d5c-74e1-4dee-a5c5-10ccec1b81db	2026-08-03	Warnings	Exact identifier application number: M012
RIGHT REMEDIES Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Strive Pharmaceuticals Inc.	51c4dcfb-8725-d547-e063-6394a90ac04c	2026-07-31	Warnings	Exact identifier application number: M012
Stona for Children	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Sato Pharmaceutical Co., Ltd.	18f3d694-9dff-407e-a264-916dbd201f9a	2026-07-31	Warnings	Exact identifier application number: M012
Stonarhini	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE	Sato Pharmaceutical Co., Ltd.	cc353280-0b4c-418c-93fe-850125955009	2026-07-31	Warnings	Exact identifier application number: M012
cold and flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Meijer Distribution Inc	5519e918-71cb-4430-ae57-e03cd5ac6002	2026-07-31	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	9819522f-f3db-4cb8-9680-423114ace2f6	2026-07-31	Warnings	Exact identifier application number: M012
Sinus Relief Daytime, Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	352b89b5-6995-4873-a103-e8f89074fdc9	2026-07-30	Warnings	Exact identifier application number: M012
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer Distribution Inc	f1e83e43-011c-4470-bd55-fb2818a9fc84	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
TOPCARE NITE TIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	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