FDA.reportPublic FDA data

NDC 51672-4074-01 - 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
51672-4074
Requested NDC
51672-4074-01
Package NDCs from labels
51672-4074-5, 51672-4074-7, 51672-4074-1, 51672-4074-2, 51672-4074-6, 51672-4074-01
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
51672-4074-1Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-1Hydrocortisone Butyrate15 g in 1 TUBECREAM155
51672-4074-2Hydrocortisone Butyrate30 g in 1 TUBECREAM305
51672-4074-2Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-5Hydrocortisone Butyrate5 g in 1 TUBECREAM55
51672-4074-6Hydrocortisone Butyrate45 g in 1 TUBECREAM455
51672-4074-6Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-7Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-7Hydrocortisone Butyrate10 g in 1 TUBECREAM105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4074HYDROCORTISONE 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
51672-4074-1GM - Gram51672-4074e175c1af-8333-4d53-bdc8-9d48bb0de46f12012-07-24
51672-4074-6GM - Gram51672-40744eeceb59-6e4f-4111-8f59-ee88a7b420e912012-07-24

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 85 of 92 · 1,840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
unii: ND2M416302
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
unii: T5L8T28FGP
Family WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
TheraPlus PlusPHENYLEPHRINE HCIZhejiang Jingwei Pharmaceutical Co., Ltd.edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d2023-10-25WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
unii: 4T6H12BN9U
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
unii: ND2M416302
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Preps SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd65c8f4de-6516-4caa-a458-228b7b4f6f782023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad 70 Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltdaf84e47f-01d6-d24e-e053-2a95a90a7edd2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad Non-SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd9b835128-194a-4527-abd5-c507ca94b1972023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltda4d1f759-7f35-d277-e053-2a95a90abc8c2023-10-23WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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