Home NDC 58809-189 VANACOF CP Allergy / Cough
Product NDC 58809-189
11-digit product format 588090189
Labeler code 58809
Product ID 58809-189_41209869-f054-7352-e063-6294a90aa5ab
Type HUMAN OTC DRUG
Nonproprietary name Chlophedianol HCl, Pyrilamine Maleate
Dosage form SOLUTION
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-06
Substance CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength 12.5; 25 mg/15mL; mg/15mL
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 VANACOF CP Allergy / Cough
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg/15mL PYRILAMINE MALEATE 25 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 69QQ58998Y Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2672917 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 58809-189-08 VANACOF CP Allergy / Cough 237 mL in 1 BOTTLE SOLUTION 237 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-189 VANACOF CP ALLERGY / COUGH (CHLOPHEDIANOL HCL, PYRILAMINE MALEATE) SOLUTION [GM PHARMACEUTICALS, INC] 5 Current NDC, 1 package rows 20241011_0bdea30a-39da-6611-e063-6394a90aa4cf.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 123 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 58809-189-08 58809018908 237 mL in 1 BOTTLE (58809-189-08) 237 ml 2023-12-06 No No Current