Home NDC 65131-418 BRONCOCHEM
Product NDC 65131-418
11-digit product format 651310418
Labeler code 65131
Product ID 65131-418_d42910c8-7859-41af-ae13-a7e442b6924f
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate-Dextromethrophan HBr
Dosage form SYRUP
Route ORAL
Labeler LABORATORIO MAGANCEHM INTERNATIONAL SRL
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2017-05-01
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 2; 10 mg/10mL; mg/10mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 BRONCOCHEM
Brand name suffix KIDS ALLERGY CONTROL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE 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 V1Q0O9OJ9Z 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 636568 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 65131-418-09 BRONCOCHEMKIDS ALLERGY CONTROL 1 in 1 BOX SYRUP 1 1 65131-418-09 BRONCOCHEMKIDS ALLERGY CONTROL 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65131-418 BRONCOCHEM KIDS ALLERGY CONTROL (CHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBR) SYRUP [LABORATORIO MAGANCEHM INTERNATIONAL SRL] 1 Current NDC, Legacy NDC, 2 package rows 20170501_36574266-a6ca-443d-9e1d-85240aabe8a2.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65131-418-09 65131041809 1 BOTTLE, PLASTIC in 1 BOX (65131-418-09) / 120 mL in 1 BOTTLE, PLASTIC 2017-05-01 0000-00-00 No No Current