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 29 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER	ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS	MEDWISE LIFESCIENCES INC.	51d52ce4-98c4-2b9b-e063-6294a90ade44	2026-05-15	Warnings	Exact identifier application number: M012
Curewell Tussin DM	DEXTROMETHORPHAN, GUAIFENESIN	RMT HEALTH LLC	4fe9ad93-cdc4-b4df-e063-6294a90a90ae	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Orchard Cherry	MENTHOL	Melaleuca, Inc.	6049842c-d763-4a91-a225-976ed74e1693	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Honey Lemon	MENTHOL	Melaleuca, Inc.	84ac3489-9d64-401f-ab78-715af4de5440	2026-05-15	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	51e03b5b-b05a-07c1-e063-6394a90ab201	2026-05-15	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/Daytime	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Rite Aid Corporation	38d73a1e-ac78-4f67-9291-bb48ab80306e	2026-05-15	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALMART INC.	071615ba-f50a-4d2a-a358-43140bccce72	2026-05-14	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	d4bcfabb-a054-4f53-8dc9-d361a03558b8	2026-05-14	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	4444c05a-eba6-4633-b86f-34f455699fa9	2026-05-14	Warnings	Exact identifier application number: M012
Topcare Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	a88e5b8e-e6dd-4a1c-9628-5861d3205bdb	2026-05-14	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	69b24c67-cf4b-46d7-a44b-d1917cc876b1	2026-05-14	Warnings	Exact identifier application number: M012
GILTUSS DIABETIC EX	GILTUSS DIABETIC EX	Gil Pharmaceutical Corp	ab7915e7-323a-4fe1-887a-a3bd3f0aac98	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Maximum Strength Expectorant	GILTUSS EX MAXIMUM STRENGTH EXPECTORANT	Gil Pharmaceutical Corp	950db1ca-6936-47f8-a112-e3594d4c922c	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GILTUSS EX EXPECTORANT	Gil Pharmaceutical Corp	3b363fb9-c4d3-446f-927c-f705ffc715b5	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss HBP EX Expectorant	GILTUSS HBP EX EXPECTORANT	Gil Pharmaceutical Corp	31bd6356-27cf-4188-8fd5-9cd9392021ca	2026-05-13	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