Home NDC 58809-187 VANACOF XP Cough / Chest Congestion
Product NDC 58809-187
11-digit product format 588090187
Labeler code 58809
Product ID 58809-187_47e37d77-7dd5-fa9d-e063-6294a90a0401
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-06
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 396; 18 mg/15mL; mg/15mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 VANACOF XP Cough / Chest Congestion
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 396 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 18 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671189 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 58809-187-08 VANACOF XP Cough / Chest Congestion 237 mL in 1 BOTTLE SOLUTION 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-187 VANACOF XP COUGH / CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [GM PHARMACEUTICALS, INC] 4 Current NDC, 1 package rows 20240119_0b3a8cc1-a49f-e1e5-e063-6394a90a1c06.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 Sample Exclude flag Status 58809-187-08 58809018708 237 mL in 1 BOTTLE (58809-187-08) 237 ml 2023-12-06 No No Current