Home NDC 10135-789 Guaifenesin 200mg
Product NDC 10135-789
11-digit product format 101350789
Labeler code 10135
Product ID 10135-789_437e388b-2293-0064-e063-6394a90add05
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
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 10135-789-01 Guaifenesin 200mg 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-789 GUAIFENESIN 200MG (GUAIFENESIN) TABLET [MARLEX PHARMACEUTICALS INC] 1 Current NDC, 1 package rows 20240319_13b8f480-d1ac-d70c-e063-6394a90ab4f4.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10135-789-01 10135078901 100 TABLET in 1 BOTTLE (10135-789-01) 100 tablet 2024-03-01 No No Current