FDA.reportPublic FDA data

betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar]

RxCUI
1716099
RxNorm name
betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar]
Display name
ENSTILAR (Topical)
Full name
betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar]
Term type
SBD
Status
Active
Strength
0.0643-0.005%
Dose form
Foam
Route
Topical
Updated
2026-10-21 00:29:26

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112015
Active start
112015
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
betamethasone dipropionate0.643 MG / 1 MLbetamethasonebetamethasone dipropionate
calcipotriene0.05 MG / 1 MLcalcipotrienecalcipotriene

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Foam346285

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
betamethasone1514
calcipotriene29365

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STREnstilar 0.005 % / 0.064 % Topical Foam1NAMES
RxNorm Namebetamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDd1193df2-d53f-4342-bd9d-d9cba7c897091CODES
RxCUI17160991CODES
MMSL_CODEBD305971CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50222-302-6050222-302ENSTILAR calcipotriene and betamethasone dipropionateLEO Pharma Inc.NDA207589
50222-302-6650222-302ENSTILAR calcipotriene and betamethasone dipropionateLEO Pharma Inc.NDA207589
50222-302-9150222-302ENSTILAR calcipotriene and betamethasone dipropionateLEO Pharma Inc.NDA207589

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA20758950222-302ENSTILAR calcipotriene and betamethasone dipropionateNDALEO Pharma Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
50222030260rxnav_ndcsyes
50222030266rxnav_ndcsyes
50222030291rxnav_ndcsyes

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
ENSTILARCALCIPOTRIENE AND BETAMETHASONE DIPROPIONATELEO Pharma Inc.d1193df2-d53f-4342-bd9d-d9cba7c897092021-10-18Warnings, Adverse reactionsExact identifier
ndc (package): 50222-302-91
ndc (package): 50222-302-66
ndc (package): 50222-302-60
ndc (product): 50222-302
ndc11 (package): 50222030291
ndc11 (package): 50222030260
ndc11 (package): 50222030266
rxcui: 1716099

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d1193df2-d53f-4342-bd9d-d9cba7c89709Enstilar 0.005 % / 0.064 % Topical Foam [PSN] · betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar] [SBD] · Enstilar (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical Foam [SY] · Enstilar 0.005 % / 0.064 % Topical Foam [SY]415These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 200620211018

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d1193df2-d53f-4342-bd9d-d9cba7c89709These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006LEO Pharma Inc. | LEO Laboratories Ltd.20211018

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC05AACorticosteroidsATC1-4betamethasone
ATCS03BACorticosteroidsATC1-4betamethasone
ATCS02BACorticosteroidsATC1-4betamethasone
ATCR01ADCorticosteroidsATC1-4betamethasone
ATCA07EACorticosteroids acting locallyATC1-4betamethasone
ATCS01BACorticosteroids, plainATC1-4betamethasone
ATCD07ACCorticosteroids, potent (group III)ATC1-4betamethasone
ATCD07XCCorticosteroids, potent, other combinationsATC1-4betamethasone
ATCS01CBCorticosteroids/antiinfectives/mydriatics in combinationATC1-4betamethasone
ATCR03BAGlucocorticoidsATC1-4betamethasone
ATCH02ABGlucocorticoidsATC1-4betamethasone
ATCD05AXOther antipsoriatics for topical useATC1-4calcipotriene
FDASPLD014807Vitamin DCHEMhas_chemical_structurecalcipotriene
FDASPLN0000175576CorticosteroidEPChas_epcbetamethasone
FDASPLN0000175849Vitamin D AnalogEPChas_epccalcipotriene
FDASPLN0000175450Corticosteroid Hormone Receptor AgonistsMOAhas_moabetamethasone
MEDRTD001623BetamethasoneCHEMhas_ingredientbetamethasone dipropionate
MEDRTD001623BetamethasoneCHEMhas_ingredientbetamethasone
MEDRTD002117CalcitriolCHEMhas_ingredientcalcipotriene
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatbetamethasone
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatbetamethasone dipropionate
MEDRTD012628Dermatitis, SeborrheicDISEASEmay_treatbetamethasone dipropionate
MEDRTD012628Dermatitis, SeborrheicDISEASEmay_treatbetamethasone
MEDRTD004342Drug HypersensitivityDISEASEci_withbetamethasone
MEDRTD004342Drug HypersensitivityDISEASEci_withcalcipotriene
MEDRTD004342Drug HypersensitivityDISEASEci_withbetamethasone dipropionate
MEDRTD005148Facial DermatosesDISEASEmay_treatbetamethasone
MEDRTD005148Facial DermatosesDISEASEmay_treatbetamethasone dipropionate
MEDRTD005533Foot DermatosesDISEASEmay_treatbetamethasone
MEDRTD005533Foot DermatosesDISEASEmay_treatbetamethasone dipropionate
MEDRTD006229Hand DermatosesDISEASEmay_treatbetamethasone dipropionate
MEDRTD006229Hand DermatosesDISEASEmay_treatbetamethasone
MEDRTD006934HypercalcemiaDISEASEci_withcalcipotriene
MEDRTD007249InflammationDISEASEmay_treatbetamethasone dipropionate
MEDRTD007249InflammationDISEASEmay_treatbetamethasone
MEDRTD007868Leg DermatosesDISEASEmay_treatbetamethasone dipropionate
MEDRTD007868Leg DermatosesDISEASEmay_treatbetamethasone
MEDRTD009181MycosesDISEASEci_withbetamethasone
MEDRTD009181MycosesDISEASEci_withbetamethasone dipropionate
MEDRTD011538Pruritus AniDISEASEmay_treatbetamethasone
MEDRTD011538Pruritus AniDISEASEmay_treatbetamethasone dipropionate
MEDRTD011565PsoriasisDISEASEmay_treatbetamethasone
MEDRTD011565PsoriasisDISEASEmay_treatcalcipotriene
MEDRTD011565PsoriasisDISEASEmay_treatbetamethasone dipropionate
MEDRTD016553Purpura, Thrombocytopenic, IdiopathicDISEASEci_withbetamethasone
MEDRTD016553Purpura, Thrombocytopenic, IdiopathicDISEASEci_withbetamethasone dipropionate
MEDRTD012536Scalp DermatosesDISEASEmay_treatbetamethasone
MEDRTD012536Scalp DermatosesDISEASEmay_treatbetamethasone dipropionate
MEDRTN0000000163Enzyme InteractionsMOAhas_moacalcipotriene
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moabetamethasone
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moabetamethasone dipropionate
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moabetamethasone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moabetamethasone dipropionate
MEDRTN0000008297Antipruritic ActivityPEhas_pebetamethasone dipropionate
MEDRTN0000008297Antipruritic ActivityPEhas_pebetamethasone
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pebetamethasone dipropionate
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pebetamethasone
MEDRTN0000009928Decreased Cellular MigrationPEhas_pebetamethasone
MEDRTN0000009928Decreased Cellular MigrationPEhas_pebetamethasone dipropionate
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pebetamethasone dipropionate
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pebetamethasone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pebetamethasone dipropionate
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pebetamethasone
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pebetamethasone
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pebetamethasone dipropionate
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pebetamethasone
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pebetamethasone dipropionate
MEDRTN0000008841Decreased Protein SynthesisPEhas_pebetamethasone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pebetamethasone dipropionate
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pebetamethasone dipropionate
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pebetamethasone
MEDRTN0000009933Increased Vitamin Uptake and ModificationPEhas_pecalcipotriene
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pebetamethasone dipropionate
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pebetamethasone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.643 MG/ML (expressed as betamethasone dipropionate) / 0.05 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA207589
NAMESPrescribable SynonymEnstilar 0.005 % / 0.064 % Topical Foam
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon