Guaifenesin

Product NDC: 0904-5154
11-digit product format: 009045154
Labeler code: 0904
Product ID: 0904-5154_cec9f1e6-0f50-44af-866c-d87f8f8975d1
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: 2026-12-31
Current FDA listing: Yes

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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	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