MUCUS RELIEF

Product NDC: 57896-794
11-digit product format: 578960794
Labeler code: 57896
Product ID: 57896-794_284e3828-f883-997b-e063-6394a90ac514
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Geri-Care Pharmaceuticals, Corp
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-01
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	57896-794	57896-794-03	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
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
bb72de5d-d3c0-42fc-ae52-a3ad95214af5	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
57896-794-01	2021-02-15	gc 794
57896-794-03	2021-02-15	gc 794
57896-794-06	2021-02-15	gc 794
57896-794-01	2021-01-29	gc 794
57896-794-03	2021-01-29	gc 794
57896-794-06	2021-01-29	gc 794

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57896-794-01	MUCUS RELIEF	100 in 1 BOTTLE	TABLET	100	7
57896-794-03	MUCUS RELIEF	30 in 1 BOTTLE	TABLET	30	7
57896-794-06	MUCUS RELIEF	60 in 1 BOTTLE	TABLET	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-794-01	EA - Each	57896-794	381f87a8-ebdd-4389-b7c5-565cac8683b1	1	2013-08-02
57896-794-06	EA - Each	57896-794	9cd46e8c-842e-43bc-84f6-792f6156e495	1	2018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-794	MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	7	Current NDC, Legacy NDC, 3 package rows	20241204_bb72de5d-d3c0-42fc-ae52-a3ad95214af5.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	3270f369-7a40-186d-e063-6394a90a8526	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe44d1ee-1e03-b74f-e053-6294a90a8bb4	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	31ac6883-ffcd-39de-e063-6294a90a52dd	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	325b41e1-f8d2-02ee-e063-6394a90aafff	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	326f1fd3-73ab-e515-e063-6294a90ab222	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6c85df30-a601-4de6-9fd6-818265d799ff	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7050b583-c09b-4457-9a9c-70c0923b62c0	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	27312ee4-d1f4-4a95-9c45-91fa5a01f5ba	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	37de53a7-5546-3804-e063-6294a90a0fb5	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	36b07e49-c72c-45e5-e063-6394a90a804a	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Clear and Cool Severe Congestion	OXYMETAZOLINE HCI	Reckitt Benckiser LLC	2ee95e17-bd94-d717-e063-6294a90a2173	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Sinus Pressure Severe Congestion	OXYMETAZOLINE HCI	Reckitt Benckiser LLC	2eeafd83-230c-af92-e063-6294a90a984e	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Congestion and Headache Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7017328-f8af-4601-9232-dc1104feaa0a	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain Headache and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	32375b12-75ed-d605-e063-6294a90ad004	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	07da45b5-d05e-41b1-b233-f7034d556a8d	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	ad4e0e4d-cc1f-4176-835f-3ba76564c634	2026-05-19	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	60daf6e2-ded8-44e6-bd8d-9d221384adde	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Childrens Mini Melts Cold and Flu	ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	401fe0a0-ec97-5248-e063-6394a90af27f	2026-05-19	Warnings	Exact identifier application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, Night	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	WALMART INC.	312ae879-1124-40a4-b2ba-3f3070840021	2026-05-19	Warnings	Exact identifier application number: M012
GOOD SENSE DAYTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2597e84c-18b4-41a9-8e6a-ff0c4c1f0612	2026-05-18	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	9ed5611f-4e1d-4f71-b430-a2a949bf7fe5	8
359601	guaifenesin 400 MG Oral Tablet	SCD	9ed5611f-4e1d-4f71-b430-a2a949bf7fe5	8
359601	guaiFENesin 400 MG Oral Tablet	PSN	bb72de5d-d3c0-42fc-ae52-a3ad95214af5	7
359601	guaifenesin 400 MG Oral Tablet	SCD	bb72de5d-d3c0-42fc-ae52-a3ad95214af5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-794-01	57896079401	100 TABLET in 1 BOTTLE (57896-794-01)	100 tablet	2012-01-01	0000-00-00	No	No	Current
57896-794-03	57896079403	30 TABLET in 1 BOTTLE (57896-794-03)	30 tablet	2012-01-01	0000-00-00	No	No	Current
57896-794-06	57896079406	60 TABLET in 1 BOTTLE (57896-794-06)	60 tablet	2018-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
gc 794	Bryant Ranch Prepack	2026-04-17	HUMAN OTC DRUG LABEL	8
gc 794	Geri-Care Pharmaceuticals, Corp	2024-12-02	HUMAN OTC DRUG LABEL	7