Home NDC 51316-578 Childrens Cold and Cough
Product NDC 51316-578
11-digit product format 513160578
Labeler code 51316
Product ID 51316-578_341dde12-06f5-4baf-9ce1-38f4ee5f95f1
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine maleate, Dextromethorphan, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler CVS
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-17
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 10; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090463 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 51316-578-03 Childrens Cold and Cough 1 in 1 CARTON LIQUID 1 3 51316-578-03 Childrens Cold and Cough 118 mL in 1 BOTTLE LIQUID 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-578 CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCL) LIQUID [CVS] 2 Current NDC, 2 package rows 20250119_2bc3eae8-ffe6-bc96-e063-6394a90a2283.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 73 of 178 · 3,551 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 51316-578-03 51316057803 1 BOTTLE in 1 CARTON (51316-578-03) / 118 mL in 1 BOTTLE 1 bottle 2025-01-17 No No Current