Guaifenesin

Product NDC: 0904-5154
11-digit product format: 009045154
Labeler code: 0904
Product ID: 0904-5154_9a9743de-1619-4d95-868f-d125b1d409e4
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-10-05
Substance: GUAIFENESIN
Active strength: 200 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Guaifenesin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	200 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
197741	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
aa662428-e61f-4e22-af4d-8cf63df68c99	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	Strength	SPL version
0904-5154-60	Guaifenesin	100 in 1 BOTTLE, PLASTIC	TABLET	100		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5154-60	EA - Each	0904-5154	0d39630a-f133-4d2c-bf29-7ec9c4ac5ca9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	13
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5154	GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]	25	Current NDC, Legacy NDC, 1 package rows	20250512_aa662428-e61f-4e22-af4d-8cf63df68c99.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 38 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vicks Sinex Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	cfd048c9-2f33-101d-e053-2995a90ad854	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	d0768332-7c24-7c30-e053-2a95a90a26d4	2026-04-22	Warnings	Exact identifier application number: M012
Histanaz	PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	3e87d0f3-f16c-5972-e063-6294a90acc8a	2026-04-22	Warnings	Exact identifier application number: M012
Good Sense Severe Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	L. Perrigo Company	d5faf89f-3641-4be1-8d43-35504f12fe8d	2026-04-22	Warnings	Exact identifier application number: M012
Multi-Symptom Cold childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd4	2026-04-22	Warnings	Exact identifier application number: M012
good sense nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	95f23049-e523-4c59-904c-b8e9ae82602c	2026-04-22	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	c07dad99-87b0-419b-9230-7c22a77ecf9e	2026-04-21	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Valu Merchandisers Company	83db90da-9155-4f6a-8209-44c87d14b696	2026-04-21	Warnings	Exact identifier application number: M012
Pain, Headache and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	613a2516-fc61-4bb4-bd44-ca6004548193	2026-04-21	Warnings	Exact identifier application number: M012
Dr. Simi Allergy Relief	DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4fe8bbe3-13c9-5458-e063-6294a90a9064	2026-04-20	Warnings	Exact identifier application number: M012
Cold and Flu Day and Night, Severe	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	58d722ef-db67-44ac-a295-dd10e1f5ca1d	2026-04-20	Warnings	Exact identifier application number: M012
Loratadine 10mg	LORATADINE	BETTER LIVING BRANDS, LLC	46d615dd-45d5-2dfc-e063-6394a90a5d42	2026-04-18	Warnings	Exact identifier application number: M012
Multi-Symptom Cold Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Valu Merchandisers Company	d0f896a6-5637-45ef-bf60-b343cbcdcf7e	2026-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Bryant Ranch Prepack	9ed5611f-4e1d-4f71-b430-a2a949bf7fe5	2026-04-17	Warnings	Exact identifier application number: M012
Multi-Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Valu Merchandisers Company	bf3158af-89ab-4b7c-9f39-0f316fbe9056	2026-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Bryant Ranch Prepack	761825bc-f835-4947-bfa0-2940f1dff5fb	2026-04-17	Warnings	Exact identifier application number: M012
equate cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	e83d14cc-9b90-40ce-a00a-2702d8a8968f	2026-04-17	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	0b34b5a3-98a2-4096-9d95-071bb5a63c86	2026-04-17	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Walgreen Company	1cd69ede-29c6-4216-95b7-b58fc96c084b	2026-04-16	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Valu Merchandisers Company	cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13	2026-04-16	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
197741	guaiFENesin 200 MG Oral Tablet	PSN	aa662428-e61f-4e22-af4d-8cf63df68c99	26
197741	guaifenesin 200 MG Oral Tablet	SCD	aa662428-e61f-4e22-af4d-8cf63df68c99	26
197741	guaiFENesin 200 MG Oral Tablet	PSN	15c87250-7c30-4565-b451-b87c6754a371	2
197741	guaiFENesin 200 MG Oral Tablet	PSN	9de5e639-d676-4379-9cb5-d99014ebca6c	2
197741	guaifenesin 200 MG Oral Tablet	SCD	15c87250-7c30-4565-b451-b87c6754a371	2
197741	guaifenesin 200 MG Oral Tablet	SCD	9de5e639-d676-4379-9cb5-d99014ebca6c	2
197741	guaiFENesin 200 MG Oral Tablet	PSN	bf32f7e3-2973-434a-a3c5-7e40bedf5f2a	1
197741	guaifenesin 200 MG Oral Tablet	SCD	bf32f7e3-2973-434a-a3c5-7e40bedf5f2a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5154-60	00904515460	100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60)	100 tablet	2009-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major 44-588	Major Pharmaceuticals \| LNK International, Inc.	2026-06-08	HUMAN OTC DRUG LABEL	27
Major 44-588	REMEDYREPACK INC.	2022-03-11	HUMAN OTC DRUG LABEL	4
Guaifenesin - Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-04-19	HUMAN OTC DRUG LABEL	2
Major 44-588	REMEDYREPACK INC.	2017-08-01	HUMAN OTC DRUG LABEL	2
Guaifenesin - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-03-01	HUMAN OTC DRUG LABEL	1