FDA.reportPublic FDA data

NDC 51672-4083-01 - Hydrocortisone Butyrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-4083
Requested NDC
51672-4083-01
Package NDCs from labels
51672-4083-5, 51672-4083-7, 51672-4083-1, 51672-4083-2, 51672-4083-6, 51672-4083-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Butyrate Ointment, 0.1% Hydrocortisone Butyrate Cream USP, 0.1% Hydrocortisone Butyrate Topical Solution, 0.1%Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4083-1Hydrocortisone Butyrate15 g in 1 TUBEOINTMENT155
51672-4083-1Hydrocortisone Butyrate1 in 1 CARTONOINTMENT15
51672-4083-2Hydrocortisone Butyrate1 in 1 CARTONOINTMENT15
51672-4083-2Hydrocortisone Butyrate30 g in 1 TUBEOINTMENT305
51672-4083-5Hydrocortisone Butyrate5 g in 1 TUBEOINTMENT55
51672-4083-6Hydrocortisone Butyrate45 g in 1 TUBEOINTMENT455
51672-4083-6Hydrocortisone Butyrate1 in 1 CARTONOINTMENT15
51672-4083-7Hydrocortisone Butyrate1 in 1 CARTONOINTMENT15
51672-4083-7Hydrocortisone Butyrate10 g in 1 TUBEOINTMENT105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4083HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 9 package rows20210409_51176835-598d-4da7-8a00-6bd36f52aa82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4083-1GM - Gram51672-4083efb8d4d9-57f2-4954-890a-9738be50e6ed12012-07-24
51672-4083-6GM - Gram51672-4083146e42f8-c9cd-4fa2-b41a-089bcca3cb9912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrocortisone ButyrateACTIVE INGREDIENT05RMF7YPWNHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
anhydrous trisodium citrateINACTIVE INGREDIENTRS7A450LGAHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
butylparabenINACTIVE INGREDIENT3QPI1U3FV8HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteth-20INACTIVE INGREDIENTI835H2IHHXHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
isopropyl alcoholINACTIVE INGREDIENTND2M416302HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
light mineral oilINACTIVE INGREDIENTN6K5787QVPHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3

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 21 of 93 · 1,855 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
unii: ND2M416302
PetroleumWHITE PETROLATUMPerrigo Direct, Ince11470b2-80d6-4008-b87e-eb6aeadfce742026-02-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Vitamin A DLANOLIN, PETROLATUMMeijer, Inc.adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec2026-02-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Petroleum Skin ProtectantWHITE PETROLATUMMeijer, Inc.af293cc0-ccd5-42a6-861b-c19fa6ffd06a2026-02-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Healing for BabiesPETROLATUMMeijer, Inc.09878fe0-0890-4af3-a3f6-d2890041e9f82026-02-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
HealingPETROLATUMMeijer, Inc.8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c12026-02-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Pure petroleumWHITE PETROLATUMTarget Corporation5237c7f2-7135-4558-a758-4fc2a232172f2026-02-18Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMTarget Corporation3e620e4f-9e29-9e39-e063-6394a90adeda2026-02-18Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Isopropyl AlcoholISOPROPYL ALCOHOLTarget Corporationb5455e53-2b86-48e7-a479-664f6601bab72026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLTarget Corporation4db7c9cb-021d-463a-9ff6-91ae42f0311d2026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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