FDA.reportPublic FDA data

chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet

RxCUI
1367227
RxNorm name
chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Display name
Chlorpheniramine/Phenylephrine (Oral Pill)
Full name
chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Term type
SCD
Status
Active
Strength
3.5-10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-27 06:56:13

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022013
Active start
022013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
chlorpheniramine maleate3.5 MG / 1 EACHchlorpheniraminechlorpheniramine maleate
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
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRchlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletNAMES
RxNorm Namechlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID69fd13a1-2b76-8574-e053-2a91aa0a27e7CODES
SPL_SET_ID8591003c-c2ec-df65-e053-2a91aa0a42fbCODES
RxCUI1367227CODES
MMSL_CODEBD30328CODES
MMSL_CODECD30328CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
58552-322-0158552-322PHENAGIL PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical CorpM012
58552-322-0258552-322PHENAGIL PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical CorpM012
58552-333-2058552-333Giltuss D Allergy and Congestion Chlorpheniramine maleate, Phenylephrine HClGil Pharmaceutical CorpM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01258552-322PHENAGIL PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEOTC MONOGRAPH DRUGGil Pharmaceutical Corp

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 7 matching rows.

NDC11, Source, Active table
NDC11SourceActive
58552031801rxnav_ndcsyes
58552032201rxnav_ndcsyes
58552032202rxnav_ndcsyes
58552033320rxnav_ndcsyes
58552033325rxnav_ndcsyes
58552033001rxnav_historical
66576032201rxnav_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
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72025-10-09WarningsExact identifier
ndc (package): 58552-322-02
ndc (package): 58552-322-01
ndc (product): 58552-322
ndc11 (package): 58552032201
ndc11 (package): 58552032202
rxcui: 1367227
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
ndc (package): 58552-333-20
ndc (product): 58552-333
ndc11 (package): 58552033325
ndc11 (package): 58552033320
rxcui: 1367227

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
69fd13a1-2b76-8574-e053-2a91aa0a27e7chlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral TabletPSN84131-Gil-Phenagil20251009
69fd13a1-2b76-8574-e053-2a91aa0a27e7chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD84131-Gil-Phenagil20251009
8591003c-c2ec-df65-e053-2a91aa0a42fbchlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD820251009
8591003c-c2ec-df65-e053-2a91aa0a42fbchlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral TabletPSN820251009
80200dc8-858e-43a4-965a-0ff7487046adchlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD1Relieve Allergy and Congestion with: PHENAGIL ® ANTIHISTAMINE AND NASAL DECONGESTANT DYE FREE PRESERVATIVE FREE SODIUM FREE SUGAR FREE20220613
80200dc8-858e-43a4-965a-0ff7487046adchlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral TabletPSN1Relieve Allergy and Congestion with: PHENAGIL ® ANTIHISTAMINE AND NASAL DECONGESTANT DYE FREE PRESERVATIVE FREE SODIUM FREE SUGAR FREE20220613

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
69fd13a1-2b76-8574-e053-2a91aa0a27e74131-Gil-PhenagilGil Pharmaceutical Corp | Syntho Pharmaceuticals Inc20251009
8591003c-c2ec-df65-e053-2a91aa0a42fbGil Pharmaceutical Corp20251009
8591003c-c2ec-df65-e053-2a91aa0a42fbGil Pharmaceutical Corp20250310
69fd13a1-2b76-8574-e053-2a91aa0a27e74131-Gil-PhenagilGil Pharmaceutical Corp | Syntho Pharmaceuticals Inc20241024
80200dc8-858e-43a4-965a-0ff7487046adRelieve Allergy and Congestion with: PHENAGIL ® ANTIHISTAMINE AND NASAL DECONGESTANT DYE FREE PRESERVATIVE FREE SODIUM FREE SUGAR FREESyntho Pharmaceuticals, Inc.20220613

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
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
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine maleate
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine maleate
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine maleate
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
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 maleate
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine maleate
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH3.5 MG / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD30328
CODESMMSL_CODECD30328
CODESRxCUI1367227
CODESSPL_SET_ID69fd13a1-2b76-8574-e053-2a91aa0a27e7
CODESSPL_SET_ID8591003c-c2ec-df65-e053-2a91aa0a42fb
NAMESPrescribable Synonymchlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral Tablet
NAMESRXNAV_STRchlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet
NAMESRxNorm Namechlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 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