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		2026-10-16

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 66 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premier Value	COUGH DROPS CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2de803-900d-02f4-e063-6394a90a84cc	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS HONEY LEMON SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2307f3a7-f6e7-8a5d-e063-6394a90ab7eb	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2e8fbe-c1c3-79b1-e063-6394a90a4d73	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS HONEY LEMON	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2dfcc3-e599-3102-e063-6394a90ad54a	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2ead3c-b4d5-ee8f-e063-6294a90a3c39	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f42644-045b-c4b3-e063-6294a90a48fd	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS VANILLA HONEY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f45499-bf14-03e4-e063-6394a90a535c	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f3ddcc-9d4e-f1b1-e063-6294a90ac86f	2025-12-29	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a5551-4989-d8fe-e063-6394a90aeabf	2025-12-29	Warnings	Exact identifier application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f2acaa-2cc8-a999-e063-6294a90a15ce	2025-12-29	Warnings	Exact identifier application number: M012
Leader Throat Soothing Drops Creamy Strawberry	THROAT SOOTHING CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26a92ecc-6a9c-b569-e063-6394a90a8bcb	2025-12-29	Warnings	Exact identifier application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	a5ceab90-6885-4f3a-b001-97679e03c01b	2025-12-29	Warnings	Exact identifier application number: M012
Goodmeds Non-Drowsy Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	32482083-3f51-41f4-8d20-bedf143e066d	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	77c16288-68c4-476c-995f-86f505663270	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	fe457e6d-422d-496c-bcb9-33594f3c42ff	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel Diabetic	DEXTROMETHORPHAN, GUAIFENESIN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	66b3c094-809e-4d2c-bc15-46563de685cb	2025-12-29	Warnings	Exact identifier application number: M012
Fortify	MENTHOL	Natures Formulae Health Products Ltd.	781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd	2025-12-29	Warnings	Exact identifier application number: M012
Safetussin PM Nighttime Cough relief	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kramer Laboratories	33dd2245-9abd-4b32-ac76-0f45a54c0f33	2025-12-29	Warnings	Exact identifier application number: M012
Winco Foods Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	WinCo Foods, LLC	f54eb60d-c602-1272-e053-2995a90aa95a	2025-12-28	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad4d74a8-a762-4378-9016-f7c83421073e	2025-12-26	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