Home NDC 65131-116 BRONCOCHEM
Product NDC 65131-116
11-digit product format 651310116
Labeler code 65131
Product ID 65131-116_383c518a-2d0c-4346-894c-9e089094d612
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl
Dosage form SYRUP
Route ORAL
Labeler LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-12-30
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 250; 4; 13.33; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL
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 EXPECTORANT II
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/10mL CHLORPHENIRAMINE MALEATE 4 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 13.33 mg/10mL GUAIFENESIN 200 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1743369 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 65131-116-87 BRONCOCHEMEXPECTORANT II 1 in 1 BOX SYRUP 1 2 65131-116-87 BRONCOCHEMEXPECTORANT II 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65131-116 BRONCOCHEM EXPECTORANT II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 2 Current NDC, Legacy NDC, 2 package rows 20161230_d0426469-9dd1-4bd1-b81e-69d33187daa2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRONCOCHEM EXPECTORANT II ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL LABORATORIO MAGNACHEM INTERNATIONAL SRL d0426469-9dd1-4bd1-b81e-69d33187daa2 2016-12-19 Warnings Exact identifier ndc (product): 65131-116
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1743369 acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution PSN d0426469-9dd1-4bd1-b81e-69d33187daa2 2 1743369 acetaminophen 25 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution SCD d0426469-9dd1-4bd1-b81e-69d33187daa2 2 1743369 acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution SY d0426469-9dd1-4bd1-b81e-69d33187daa2 2 1743369 APAP 25 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution SY d0426469-9dd1-4bd1-b81e-69d33187daa2 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65131-116-87 65131011687 1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) / 120 mL in 1 BOTTLE, PLASTIC 2016-12-30 0000-00-00 No No Current