FDA.reportPublic FDA data

BRONCOCHEM

Product NDC
65131-035
11-digit product format
651310035
Labeler code
65131
Product ID
65131-035_5c804db7-1a93-4b7c-9c07-11cd3e80e246
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
2024-02-09
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength
15; 6 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 HYDROBROMIDE15 mg/5mL
PYRILAMINE MALEATE6 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, R35D29L3ZA
Rxcui2679777

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-035-80BRONCOCHEMMAXIMUM COUGH NIGHT120 mL in 1 BOTTLE, PLASTICSYRUP1203
65131-035-80BRONCOCHEMMAXIMUM COUGH NIGHT1 in 1 BOXSYRUP13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-035BRONCOCHEM MAXIMUM COUGH NIGHT (DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]3Current NDC, 2 package rows20240423_1a3ed214-e09b-4266-b68b-39e7c3127d26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679777dextromethorphan hydrobromide 15 MG / pyrilamine maleate 6 MG in 5 mL Oral SolutionPSN1a3ed214-e09b-4266-b68b-39e7c3127d263
2679777dextromethorphan hydrobromide 3 MG/ML / pyrilamine maleate 1.2 MG/ML Oral SolutionSCD1a3ed214-e09b-4266-b68b-39e7c3127d263
2679777dextromethorphan hydrobromide 15 MG / pyrilamine maleate 6 MG per 5 ML Oral SolutionSY1a3ed214-e09b-4266-b68b-39e7c3127d263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65131-035-80651310035801 BOTTLE, PLASTIC in 1 BOX (65131-035-80) / 120 mL in 1 BOTTLE, PLASTIC2024-02-09NoNoCurrent