FDA.reportPublic FDA data

BRONCOCHEM

Product NDC
65131-110
11-digit product format
651310110
Labeler code
65131
Product ID
65131-110_daa4b9dd-bc1f-429e-a32b-613f1b6987e8
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE
Dosage form
SYRUP
Route
ORAL
Labeler
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-21
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength
30; 50 mg/5mL; mg/5mL
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 NIGHT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL
PYRILAMINE MALEATE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, R35D29L3ZA
Rxcui2712157

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-110-35BRONCOCHEMMAXIMUM COUGH NIGHT120 mL in 1 BOTTLE, PLASTICSYRUP1201
65131-110-35BRONCOCHEMMAXIMUM COUGH NIGHT1 in 1 BOXSYRUP11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-110BRONCOCHEM MAXIMUM COUGH NIGHT (DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1Current NDC, 2 package rows20250421_dffdfa2c-a52e-4606-9b07-c8993e499f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712157dextromethorphan HBr 30 MG / pyrilamine maleate 50 MG in 5 mL Oral SolutionPSNdffdfa2c-a52e-4606-9b07-c8993e499f091
2712157dextromethorphan hydrobromide 6 MG/ML / pyrilamine maleate 10 MG/ML Oral SolutionSCDdffdfa2c-a52e-4606-9b07-c8993e499f091
2712157dextromethorphan HBr 30 MG / pyrilamine maleate 50 MG per 5 ML Oral SolutionSYdffdfa2c-a52e-4606-9b07-c8993e499f091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65131-110-35651310110351 BOTTLE, PLASTIC in 1 BOX (65131-110-35) / 120 mL in 1 BOTTLE, PLASTIC2025-04-21NoNoCurrent