FDA.reportPublic FDA data

dexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution

RxCUI
1303797
RxNorm name
dexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution
Display name
Dexbrompheniramine/Dextromethorphan/Phenylephrine (Oral Liquid)
Full name
dexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
1-10-5 mg/ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-07-21 06:56:15

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092012
Active start
092012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dexbrompheniramine maleate1 MG / 1 MLdexbrompheniraminedexbrompheniramine maleate
dextromethorphan hydrobromide10 MG / 1 MLdextromethorphandextromethorphan hydrobromide
phenylephrine hydrochloride5 MG / 1 MLphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dexbrompheniramine22696
dextromethorphan3289
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution1NAMES
RxNorm Namedexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution1NAMES
RxNorm Synonymdexbrompheniramine maleate 1 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 1 ML Oral Solution1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI13037971CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
52083-057-0152083-057SUPRESS A Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HClKramer NovisM012
65852-020-0165852-020SUPRESS A Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HClDextrum Laboratories, IncM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01252083-057SUPRESS A Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HClOTC MONOGRAPH DRUGKramer Novis

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
52083005701rxnav_ndcsyes
65852002001rxnav_ndcsyes
65852001401rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
ndc (package): 65852-020-01
ndc (product): 65852-020
ndc11 (package): 65852002001
rxcui: 1303797
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
ndc (package): 52083-057-01
ndc (product): 52083-057
ndc11 (package): 52083005701
rxcui: 1303797

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f0bec5f5-4d76-471e-9024-557eba848b93dexbrompheniramine maleate 1 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 1 mL Oral Solution [PSN] · dexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution [SCD] · dexbrompheniramine maleate 1 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 1 ML Oral Solution [SY]33SUPRESS A20250922
410c19f7-213d-cd99-e063-6294a90af5a3dexbrompheniramine maleate 1 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 1 mL Oral Solution [PSN] · dexbrompheniramine maleate 1 MG/ML / dextromethorphan hydrobromide 10 MG/ML / phenylephrine hydrochloride 5 MG/ML Oral Solution [SCD] · dexbrompheniramine maleate 1 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 1 ML Oral Solution [SY]31SUPRESS A20251013

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
410c19f7-213d-cd99-e063-6294a90af5a3SUPRESS ADextrum Laboratories, Inc20251013
402e779e-def2-131e-e063-6294a90a7efeSupress ADextrum Laboratories, Inc20251002
f0bec5f5-4d76-471e-9024-557eba848b93SUPRESS AKramer Novis20250922
f0bec5f5-4d76-471e-9024-557eba848b93SUPRESS AKramer Novis20171222
c530a5e5-7702-4e1b-8ec2-0dc0a7431c7dNational Council for Prescription Drug Programs20130213

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
ATCC05AXOther agents for treatment of hemorrhoids and anal fissures for topical useATC1-4phenylephrine
ATCR06ABSubstituted alkylaminesATC1-4dexbrompheniramine
ATCR01BASympathomimeticsATC1-4phenylephrine
ATCS01FBSympathomimetics excl. antiglaucoma preparationsATC1-4phenylephrine
ATCS01GASympathomimetics used as decongestantsATC1-4phenylephrine
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4phenylephrine
ATCR01AASympathomimetics, plainATC1-4phenylephrine
FDASPLN0000186105alpha-1 Adrenergic AgonistEPChas_epcphenylephrine
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine maleate
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine maleate
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1 MG/ML / 10 MG/ML / 5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymdexbrompheniramine maleate 1 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 1 mL Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary