BRONCOCHEM

Product NDC
65131-418
11-digit product format
651310418
Labeler code
65131
Product ID
65131-418_d42910c8-7859-41af-ae13-a7e442b6924f
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate-Dextromethrophan HBr
Dosage form
SYRUP
Route
ORAL
Labeler
LABORATORIO MAGANCEHM INTERNATIONAL SRL
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-05-01
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 10 mg/10mL; mg/10mL
Pharmacologic classes
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]
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
KIDS ALLERGY CONTROL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 9D2RTI9KYH
Rxcui636568

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-418-09BRONCOCHEMKIDS ALLERGY CONTROL1 in 1 BOXSYRUP11
65131-418-09BRONCOCHEMKIDS ALLERGY CONTROL120 mL in 1 BOTTLE, PLASTICSYRUP1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-418BRONCOCHEM KIDS ALLERGY CONTROL (CHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBR) SYRUP [LABORATORIO MAGANCEHM INTERNATIONAL SRL]1Current NDC, Legacy NDC, 2 package rows20170501_36574266-a6ca-443d-9e1d-85240aabe8a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636568chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral SolutionPSN36574266-a6ca-443d-9e1d-85240aabe8a21
636568chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD36574266-a6ca-443d-9e1d-85240aabe8a21
636568chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG per 5 ML Oral SolutionSY36574266-a6ca-443d-9e1d-85240aabe8a21
636568chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 ML Oral SolutionSY36574266-a6ca-443d-9e1d-85240aabe8a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65131-418-09651310418091 BOTTLE, PLASTIC in 1 BOX (65131-418-09) / 120 mL in 1 BOTTLE, PLASTIC2017-05-010000-00-00NoNoCurrent