Home NDC 58809-999 VANACOF
Product NDC 58809-999
11-digit product format 588090999
Labeler code 58809
Product ID 58809-999_412140cc-b107-571d-e063-6394a90a27cd
Type HUMAN OTC DRUG
Nonproprietary name Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-04-22
Substance CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg/5mL DEXCHLORPHENIRAMINE MALEATE 1 mg/5mL PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 69QQ58998Y Internal UNII lookup B10YD955QW Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369424 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 58809-999-01 VANACOF 473 mL in 1 BOTTLE LIQUID 473 13 58809-999-02 VANACOF 15 mL in 1 BOTTLE LIQUID 15 13 58809-999-02 VANACOF 12 in 1 TRAY LIQUID 12 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Chlophedianol Hydrochloride ACTIVE INGREDIENT 69QQ58998Y VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Dexchlorpheniramine Maleate ACTIVE INGREDIENT B10YD955QW VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Pseudoephedrine Hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Chlophedianol ACTIVE MOIETY 42C50P12AP VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Dexchlorpheniramine ACTIVE MOIETY 3Q9Q0B929N VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Glycerin INACTIVE INGREDIENT PDC6A3C0OX VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Sorbitol INACTIVE INGREDIENT 506T60A25R VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4 Water INACTIVE INGREDIENT 059QF0KO0R VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-999 VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 12 Current NDC, Legacy NDC, 3 package rows 20240502_cf3886ab-62b3-497a-a587-18cbfbaf3634.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 Marketing end Sample Exclude flag Status 58809-999-01 58809099901 473 mL in 1 BOTTLE (58809-999-01) 473 ml 2008-04-22 0000-00-00 No No Current 58809-999-02 58809099902 12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE 12 bottle 2008-04-22 0000-00-00 No No Current