Bromfed DM

Product NDC
60432-837
11-digit product format
604320837
Labeler code
60432
Product ID
60432-837_96641a48-5450-44bb-a1ab-25d0cf05f2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA088811
Marketing category
ANDA
Marketing start
2010-06-15
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-837-04ML - Milliliter60432-837dd90841a-bf1d-43d6-a161-ef1dec1be26a12012-07-24
60432-837-16ML - Milliliter60432-83798c39b24-f8ba-4a18-b1cd-bafa9d4d020b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Brompheniramine MaleateACTIVE INGREDIENTIXA7C9ZN03BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
BrompheniramineACTIVE MOIETYH57G17P2FNBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
DextromethorphanACTIVE MOIETY7355X3ROTSBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
PseudoephedrineACTIVE MOIETY7CUC9DDI9FBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
AlcoholINACTIVE INGREDIENT3K9958V90MBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOABROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RBROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]7
Brompheniramine MaleateACTIVE INGREDIENTIXA7C9ZN03BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
BrompheniramineACTIVE MOIETYH57G17P2FNBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
DextromethorphanACTIVE MOIETY7355X3ROTSBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOABROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
raw sugarINACTIVE INGREDIENT8M707QY5GHBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RBROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-837BROMFED DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]12Legacy NDC20210112_e241d83e-996c-494d-b3fe-97f1ef4809ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358993Bromfed DM 2 MG / 10 MG / 30 MG in 5 mL Oral SolutionPSNccdf22f3-171f-4c19-8273-fefa140d19691
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSNccdf22f3-171f-4c19-8273-fefa140d19691
1358993brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution [Bromfed DM]SBDccdf22f3-171f-4c19-8273-fefa140d19691
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCDccdf22f3-171f-4c19-8273-fefa140d19691
1358993Bromfed DM (brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 30 MG) per 5 ML Oral SolutionSYccdf22f3-171f-4c19-8273-fefa140d19691
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSYccdf22f3-171f-4c19-8273-fefa140d19691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-837-0460432083704118 mL in 1 BOTTLE, PLASTIC (60432-837-04) 118 ml2010-06-150000-00-00NoNoCurrent
60432-837-1660432083716473 mL in 1 BOTTLE, PLASTIC (60432-837-16) 473 ml2010-06-150000-00-00NoNoCurrent