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 148 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Cold XL3 Xtra	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	da5b31dd-becd-471a-9392-d0ee4b8f9539	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	MIDWAY IMPORTING INC.	58252f15-485c-3061-e053-2a91aa0a2320	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Midway Importing, Inc.	e41b9beb-e274-5c02-e053-2995a90ad0f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	38e70a28-eff2-4a48-b829-8cd68e80beef	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Midway Importing Inc.	c2c8bd26-bbf1-c2e6-e053-2995a90a86a7	2024-10-17	Warnings	Exact identifier application number: M012
Antiflu Des Cough and Flu	ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE	Productos Farmaceuticos, S.A. de C.V.	dcf3897a-a793-6df7-e053-2995a90a25f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	ec6aef90-ece1-4fe6-e053-2995a90a9310	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Cold, Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	c8eebe64-00bf-436d-a9fc-1623401bebfa	2024-10-16	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	4f42c8d2-0538-4bcd-aac0-e26103a30499	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	9ac3e24a-d18a-48fc-8005-55393085d57b	2024-10-16	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	45471fdd-c4cd-46ad-a932-aa37327e8a41	2024-10-16	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8cb15a8d-c836-4167-bc6b-dd20a34076e8	2024-10-16	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f4497e56-c69d-4ae9-bd81-80bf2ee1b17f	2024-10-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	8256c1fb-683d-56ab-e053-2a91aa0ac197	2024-10-15	Warnings	Exact identifier application number: M012
SINUS SEVRE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f9586e3-a8b4-4060-e053-2995a90aa068	2024-10-15	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95715f-63dc-6086-e053-2a95a90adb0c	2024-10-15	Warnings	Exact identifier application number: M012
Allergy MultiSymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	a61636e9-8fe2-8419-e053-2a95a90a011c	2024-10-15	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95b2e8-dea4-ef59-e053-2a95a90a0bcb	2024-10-15	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	d2dcbc7c-e66c-4922-83df-c706a37bf334	2024-10-15	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC. (	9f958d97-8dcf-332d-e053-2995a90a0a65	2024-10-15	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