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 138 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	89dc1423-d097-47a8-9025-eab5381cca26	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	10f9627b-edda-422a-b01f-7066f9c98335	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	17c3fe42-3c40-4405-80b7-b3f9e4aa8376	2024-11-11	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	1dd36aa7-f085-4350-8cf2-f9fa29b583e4	2024-11-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7f9f1d0-7498-461c-b4e8-4c92cf3feae8	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	bd079f5d-0a38-40e6-9661-e8236c88a24d	2024-11-11	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	PAI Holdings, LLC dba PAI Pharma	ff970fff-d1a3-4322-83b4-34e361431a1c	2024-11-11	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	e1118592-30ac-4505-9f38-c6d395c4cf5b	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	624b8029-9fdb-4908-a13b-f9dd75030120	2024-11-11	Warnings	Exact identifier application number: M012
Biofreeze Colorless	MENTHOL	A-S Medication Solutions	cc1cba14-da40-4d7d-b522-b5c648798e96	2024-11-11	Warnings	Exact identifier application number: M012
foster and thrive nighttime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	298b7754-d0d8-496d-9949-4c346cb11e34	2024-11-11	Warnings	Exact identifier application number: M012
leader tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	b418c10c-528b-4395-944e-af959b639ec2	2024-11-10	Warnings	Exact identifier application number: M012
equaline adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	f7c753f8-4b12-4797-a599-736d597bc1bc	2024-11-10	Warnings	Exact identifier application number: M012
foster and thrive adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Strategic Sourcing Services LLC	f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7	2024-11-10	Warnings	Exact identifier application number: M012
dg health adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	81f12484-ddf7-49c6-b530-3a81d62ab40d	2024-11-10	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Retail Business Services, LLC	230fa1ea-ae7c-425e-8447-79a90c96ae9e	2024-11-10	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	L. Perrigo Company	cb8a1d81-b1a3-4217-b157-9e5d398f202d	2024-11-09	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Acme United Corporation	5e31b1ff-291f-7b8c-e053-2a91aa0aedbc	2024-11-09	Warnings	Exact identifier application number: M012
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	55fffc1d-8449-4c28-a391-c6f60dd85622	2024-11-09	Warnings	Exact identifier application number: M012
Poly-Vent IR	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	ce0d8c45-446a-4df4-a36b-5000ba69d30d	2024-11-09	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