Home NDC 71610-434 Guaifenesin 200mg
Product NDC 71610-434
11-digit product format 716100434
Labeler code 71610
Product ID 71610-434_2b4b8161-b037-f244-e063-6294a90ae372
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-01
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 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 200mg
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-434-18 Guaifenesin 200mg 3000 in 1 BOTTLE TABLET 3000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-434 GUAIFENESIN 200MG (GUAIFENESIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20250112_45ac210a-8c54-4469-8e10-e6fe52b89cb5.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 73 of 178 · 3,550 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 71610-434-18 71610043418 3000 TABLET in 1 BOTTLE (71610-434-18) 3000 tablet 2020-06-16 0000-00-00 No No Current