SIMPEX Guaifenesin

Product NDC: 76457-004
11-digit product format: 764570004
Labeler code: 76457
Product ID: 76457-004_0b586737-4616-db6e-e063-6294a90a6135
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET
Route: ORAL
Labeler: Simpex Pharma Pvt. Ltd
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-09
Substance: GUAIFENESIN
Active strength: 400 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

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: SIMPEX Guaifenesin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 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
359601	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
1594f9d6-0c48-42bf-b76b-d621f215179a	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
76457-004-00	SIMPEX Guaifenesin	100 in 1 CARTON	TABLET	100		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76457-004	SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]	5	Current NDC, Legacy NDC, 1 package rows	20231201_1594f9d6-0c48-42bf-b76b-d621f215179a.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 156 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exchange Select Nasal	OXYMETAZOLINE HCL	Army & Air Force Exchange Service	40d2090d-c332-4dcb-9f43-5ee467e7b3d1	2024-08-27	Warnings	Exact identifier application number: M012
Signature Care Nasal Decongestant	OXYMETAZOLINE HCL	Safeway	23f0a5b3-59ae-4eb3-9b7d-e6a492060337	2024-08-27	Warnings	Exact identifier application number: M012
DG Health Nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	debcda99-c605-4941-b873-9e4dbae27483	2024-08-27	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Nasal	OXYMETAZOLINE HCL	Amerisource Bergen	d374d697-2b57-4558-a20b-d3d89aea82d7	2024-08-27	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Meijer Distribution Inc	3984cbc3-b60c-40a7-bc3a-7d1f600503ac	2024-08-27	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	e6e51821-03ae-4ec3-82a9-b4a8feacd996	2024-08-27	Warnings	Exact identifier application number: M012
Pyrilamine Maleate and Dextromethorphan Hydrobromide	PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	Westminster Pharmaceuticals, LLC	dd068449-9d24-41e6-8a6e-f69c9fe263f2	2024-08-26	Warnings	Exact identifier application number: M012
basic care nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	a154e500-2b45-4242-a26c-9530849f99df	2024-08-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0c0cf76f-2dd3-45ef-e063-6394a90a9fef	2024-08-22	Warnings	Exact identifier application number: M012
Day Cold and Flu and Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	TARGET CORPORATION	08ee56d1-b11d-3e36-e063-6294a90acd5f	2024-08-22	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE	TARGET CORPORATION	0fc523ce-55a7-6384-e063-6394a90aad3f	2024-08-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreens	8045aef9-22bc-4146-b494-dbb1ffef06df	2024-08-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5a2053d4-9c0d-4613-9cf5-0067173f3730	2024-08-16	Warnings	Exact identifier application number: M012
QUALITY CHOICE Long Acting Cough Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Marketing Association, Inc.	f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c	2024-08-16	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Padagis Israel Pharmaceuticals Ltd	458594e1-8d99-4de3-8923-2fd8ce2fc406	2024-08-16	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	54e0d57e-1f48-45e2-86b3-0e50775996f4	2024-08-15	Warnings	Exact identifier application number: M012
SanaTos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	1fc1408c-c540-39ab-e063-6394a90aa477	2024-08-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	489645ad-d7da-5f52-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6c949602-e0c8-40ce-8fb3-5147f406fa04	2024-08-14	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	3dbdf020-ca17-1197-e054-00144ff8d46c	2024-08-13	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
359601	guaiFENesin 400 MG Oral Tablet	PSN	1594f9d6-0c48-42bf-b76b-d621f215179a	5
359601	guaifenesin 400 MG Oral Tablet	SCD	1594f9d6-0c48-42bf-b76b-d621f215179a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76457-004-00	76457000400	100 TABLET in 1 CARTON (76457-004-00)	100 tablet	2018-02-09	0000-00-00	No	No	Current