Home NDC 0904-7531 childrens cold and cough
Product NDC 0904-7531
11-digit product format 009047531
Labeler code 0904
Product ID 0904-7531_b0d700aa-e478-46f1-b0fa-6040d78305a3
Type HUMAN OTC DRUG
Nonproprietary name brompheniramine maleate, dextromethorphan hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-10
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 and cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7531-20 childrens cold and cough 1 in 1 CARTON SOLUTION 1 2 0904-7531-20 childrens cold and cough 118 mL in 1 BOTTLE SOLUTION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7531 CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS] 2 Current NDC, 2 package rows 20250315_614880db-478f-468a-8aa2-5ea483cbcfcd.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 0904-7531-20 00904753120 1 BOTTLE in 1 CARTON (0904-7531-20) / 118 mL in 1 BOTTLE 1 bottle 2025-03-10 No No Current