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

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
MAXIMUM COUGH NIGHT
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2712157Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dffdfa2c-a52e-4606-9b07-c8993e499f09Available on FDA.report

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

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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

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