Home NDC 51316-513 childrens cold cough
Product NDC 51316-513
11-digit product format 513160513
Labeler code 51316
Product ID 51316-513_8d51f095-2003-4ade-9ad8-e9c2aa4b7c20
Type HUMAN OTC DRUG
Nonproprietary name brompheniramine maleate, dextromethorphan hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-17
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 2; 10 mg/10mL; mg/10mL
Pharmacologic classes 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 childrens cold cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 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 2683421 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 51316-513-26 childrens cold cough 118 mL in 1 BOTTLE SOLUTION 118 2 51316-513-26 childrens cold cough 1 in 1 CARTON SOLUTION 1 2 51316-513-34 childrens cold cough 237 mL in 1 BOTTLE SOLUTION 237 2 51316-513-34 childrens cold cough 1 in 1 CARTON SOLUTION 1 2
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 51316-513-26 51316051326 1 BOTTLE in 1 CARTON (51316-513-26) / 118 mL in 1 BOTTLE 1 bottle 2025-06-17 No No Current 51316-513-34 51316051334 1 BOTTLE in 1 CARTON (51316-513-34) / 237 mL in 1 BOTTLE 1 bottle 2025-06-17 No No Current