Home NDC 58809-190 VanaCof 2
Product NDC 58809-190
11-digit product format 588090190
Labeler code 58809
Product ID 58809-190_47e37a4b-be9d-3c99-e063-6394a90ac7c7
Type HUMAN OTC DRUG
Nonproprietary name Chlophedianol HCl, Dexchlorpheniramine Maleate
Dosage form SOLUTION
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-14
Substance DEXCHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE
Active strength 1; 12.5 mg/5mL; mg/5mL
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 2
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXCHLORPHENIRAMINE MALEATE 1 mg/5mL CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B10YD955QW Internal UNII lookup 69QQ58998Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671454 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 58809-190-16 VanaCof 2 473 mL in 1 BOTTLE SOLUTION 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-190 VANACOF 2 (CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE) SOLUTION [GM PHARMACEUTICALS, INC] 4 Current NDC, 1 package rows 20240202_0c7c6756-abb2-c10c-e063-6394a90a9863.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 58809-190-16 58809019016 473 mL in 1 BOTTLE (58809-190-16) 473 ml 2023-12-14 No No Current