Home NDC 76457-004 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.
DailyMed Product Concepts# 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# 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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# 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