Home NDC 65131-091 BRONCOCHEM
Product NDC 65131-091
11-digit product format 651310091
Labeler code 65131
Product ID 65131-091_b4e75d5f-2f1c-4ea0-84f2-705fd4631199
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HBr-GYAIFENESIN
Dosage form SYRUP
Route ORAL
Labeler LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2016-12-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 30; 200 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 Additional Listing Data#
Finished product Yes
Brand name base BRONCOCHEM
Brand name suffix MAXIMUM COUGH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL GUAIFENESIN 200 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234473 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 65131-091-08 BRONCOCHEMMAXIMUM COUGH 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 3 65131-091-08 BRONCOCHEMMAXIMUM COUGH 1 in 1 BOX SYRUP 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65131-091 BRONCOCHEM MAXIMUM COUGH (DEXTROMETHORPHAN HBR-GYAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 3 Current NDC, Legacy NDC, 2 package rows 20161230_8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65.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 65131-091-08 65131009108 1 BOTTLE, PLASTIC in 1 BOX (65131-091-08) / 120 mL in 1 BOTTLE, PLASTIC 2016-12-30 0000-00-00 No No Current