FDA.reportPublic FDA data

dimaphen dm

Product NDC
0904-6463
11-digit product format
009046463
Labeler code
0904
Product ID
0904-6463_ae06d085-220b-4bc6-8239-3917ee97d9ac
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-09-11
Marketing end
2026-11-30
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 10; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
dimaphen dm

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1090463

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6463-20dimaphen dm118 mL in 1 BOTTLESOLUTION1186
0904-6463-20dimaphen dm1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6463-20ML - Milliliter0904-6463c5139294-a0e9-4687-bc5f-503556c4b2bf12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RDIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6463DIMAPHEN DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20241119_67072a38-1ae7-4e59-bfed-71db0d93215d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN67072a38-1ae7-4e59-bfed-71db0d93215d6
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD67072a38-1ae7-4e59-bfed-71db0d93215d6
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY67072a38-1ae7-4e59-bfed-71db0d93215d6
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY67072a38-1ae7-4e59-bfed-71db0d93215d6
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNda148c1d-e394-4367-83e0-533469501b302
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDda148c1d-e394-4367-83e0-533469501b302
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSYda148c1d-e394-4367-83e0-533469501b302
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYda148c1d-e394-4367-83e0-533469501b302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6463-20009046463201 BOTTLE in 1 CARTON (0904-6463-20) / 118 mL in 1 BOTTLE1 bottle2006-09-112026-11-30NoNoCurrent