Home NDC 65131-101 BRONCOCHEM
Product NDC 65131-101
11-digit product format 651310101
Labeler code 65131
Product ID 65131-101_bc97a4b6-6711-4824-a25e-647c89553306
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate
Dosage form TABLET, COATED
Route ORAL
Labeler LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application C200263
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-01-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength 325; 20; 10; 4 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 COLD AND FLU CAPLETS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 CHLORPHENIRAMINE MALEATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2709229 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 65131-101-11 BRONCOCHEMCOLD AND FLU CAPLETS 50 in 1 BOX TABLET, COATED 50 1 65131-101-11 BRONCOCHEMCOLD AND FLU CAPLETS 2 in 1 POUCH TABLET, COATED 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65131-101 BRONCOCHEM COLD AND FLU CAPLETS (ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE) TABLET, COATED [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 Current NDC, 2 package rows 20250327_6fa52bb3-ac22-4df1-b31b-41c00181c67d.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 · 2 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 65131-101-11 65131010111 50 POUCH in 1 BOX (65131-101-11) / 2 TABLET, COATED in 1 POUCH 50 pouch 2025-04-21 No No Current