FDA.reportPublic FDA data

chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet

RxCUI
1593105
RxNorm name
chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Display name
Chlorpheniramine/Dextromethorphan/Phenylephrine (Oral Pill)
Full name
chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Term type
SCD
Status
Active
Strength
4-10-10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-15 14:49:23

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122014
Active start
122014
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
chlorpheniramine maleate4 MG / 1 EACHchlorpheniraminechlorpheniramine maleate
dextromethorphan hydrobromide10 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
phenylephrine hydrochloride10 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
chlorpheniramine2400
dextromethorphan3289
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRchlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
RxNorm Namechlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID07cd07a1-d84c-4a91-8fa6-5eb58dd239911CODES
RxCUI15931051CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0485-0240-010485-0240ED-A-HIST DM CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
00485024001rxnav_ndcsyes
58605011101rxnav_ndcsyes
66576024001rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ED-A-HIST DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.07cd07a1-d84c-4a91-8fa6-5eb58dd239912026-03-04WarningsExact identifier
ndc (package): 0485-0240-01
ndc (product): 0485-0240
ndc11 (package): 00485024001
rxcui: 1593105

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
07cd07a1-d84c-4a91-8fa6-5eb58dd23991chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]27ED-A-HIST DM TABLETS20260304
ca13b8c2-022b-4eab-a573-8e4a65e33130chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]21ED A-HIST DM TABLETS20221103

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
07cd07a1-d84c-4a91-8fa6-5eb58dd23991ED-A-HIST DM TABLETSEDWARDS PHARMACEUTICALS, INC.20260304
07cd07a1-d84c-4a91-8fa6-5eb58dd23991ED-A-HIST DM TABLETSEDWARDS PHARMACEUTICALS, INC.20251106
ca13b8c2-022b-4eab-a573-8e4a65e33130ED A-HIST DM TABLETSSyntho Pharmaceuticals, Inc.20221103

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 alkylaminesATC1-4chlorpheniramine
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
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcchlorpheniramine
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine maleate
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine maleate
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine maleate
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine maleate
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine maleate
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine maleate
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH4 MG / 10 MG / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4033890
NAMESPrescribable Synonymchlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File