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 56 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Seacall Nasal Spray.	NASAL SPRAY	Guangdong Quadrant Ecological Technology Co., Ltd.	1f12618b-7461-fb47-e063-6294a90af753	2026-01-23	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecf7d210-102c-4053-81f6-67116de6cf7b	2026-01-23	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	44f9255b-0bf9-4573-ac9c-410acb515bc2	2026-01-23	Warnings	Exact identifier application number: M012
Daytime cold and flu non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Meijer Distribution Inc	29caa3a7-7fe6-4134-a9b0-49bdb9280ca7	2026-01-23	Warnings	Exact identifier application number: M012
good neighbor pharmacy night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7	2026-01-23	Warnings	Exact identifier application number: M012
RAYO ACTIVE ICE	MENTHOL, CAMPHOR	Quimicas Handal de Centroamerica SA de CV	09e4a36b-020a-c5b1-e063-6394a90a3e31	2026-01-22	Warnings	Exact identifier application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc.	f466fc0e-3384-4884-832e-99bf1fdcf899	2026-01-21	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR GUAIFENESIN	Strategic Sourcing Services LLC	84750bfb-9e94-40a3-b731-21799f5e4fd1	2026-01-20	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Amerisource Bergen	0b58990f-2246-408e-9365-51f56bb6766c	2026-01-20	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	a8460fc9-2d08-4e5f-8dd3-5135ecda5923	2026-01-20	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Family Dollar Services Inc	0a651316-623e-41eb-ab3a-641f5d807425	2026-01-20	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu	WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	Walgreens	579c47c8-6366-4785-9680-d3986ce9641d	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold	WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD	Walgreens	dd61c9d3-0b70-450e-9525-282710b383cc	2026-01-19	Warnings	Exact identifier application number: M012
Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	48bf7422-38ef-d4b4-e063-6294a90aa3ab	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	fc670515-a820-4ea7-8786-8ae710798b31	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	WALGREENS	9dece7b1-00b1-2499-e053-2a95a90a0be3	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	2dba2bec-e0e3-4910-89c5-ebc093e05bec	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	ca3c1eb4-6099-5e5f-e053-2995a90ab61b	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	fe6dff90-18f1-491e-84b9-cc74bb1831ba	2026-01-19	Warnings	Exact identifier application number: M012
Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens Company	ec8c73d5-b190-432a-92c6-68ea0fc86ea6	2026-01-19	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