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 51 of 92 · 1,840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7d0e8-12b4-e410-e053-2a95a90a7f302025-08-21WarningsExact identifier
unii: ND2M416302
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edaff0ca-f305-71a4-e053-2a95a90a5dca2025-08-18WarningsExact identifier
unii: ND2M416302
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edb4a43a-5b55-3404-e053-2a95a90ada272025-08-18WarningsExact identifier
unii: ND2M416302
MedPride Vitamin A and DWHITE PETROLATUMShield Line LLC360085ae-29fc-41c9-9875-c902f197a8712025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Petrolatum with Cocoa ButterPETROLATUMShield line LLC3e9c68e5-8983-1a18-e054-00144ff8d46c2025-08-18WarningsExact identifier
unii: 4T6H12BN9U
MedprideWHITE PETROLATUMShield Line LLC0c4201e1-54f5-4d44-a31a-89aaa511d6b52025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Baby Petrolatum JellyPETROLATUMShield Line LLC3e9cf8bf-929b-45bf-e054-00144ff8d46c2025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Linen Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.3890a5df-0d91-1391-e063-6294a90a204c2025-08-17WarningsExact identifier
unii: ND2M416302
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.36c1bfc0-fd96-a058-e063-6294a90a93b32025-08-17WarningsExact identifier
unii: ND2M416302
Dark 6-Pack Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC3c9425a7-4eb9-1a63-e063-6294a90a49a42025-08-17WarningsExact identifier
unii: ND2M416302
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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