Home NDC 76162-099 topcare childrens cold cough
Product NDC 76162-099
11-digit product format 761620099
Labeler code 76162
Product ID 76162-099_59d16f9e-d90f-4d4d-b5fa-54e2c5dcf159
Type HUMAN OTC DRUG
Nonproprietary name brompheniramine maleate, dextromethorphan hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-12
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 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 topcare childrens cold cough
Listing expiration 2026-12-31 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 76162-099-26 topcare childrens cold cough 118 mL in 1 BOTTLE SOLUTION 118 2 76162-099-26 topcare 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 98 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 76162-099-26 76162009926 1 BOTTLE in 1 CARTON (76162-099-26) / 118 mL in 1 BOTTLE 1 bottle 2025-06-12 No No Current