FDA.reportPublic FDA data

NDC 51672-1292-01 - Hydrocortisone Valerate

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
51672-1292
Requested NDC
51672-1292-01
Package NDCs from labels
51672-1292-1, 51672-1292-6, 51672-1292-3, 51672-1292-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceuticals Industries Ltd.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Valerate Cream USP, 0.2% Hydrocortisone Valerate Ointment USP, 0.2%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceuticals Industries Ltd.2025-07-07HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Valerate - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-10-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1292-1Hydrocortisone Valerate1 in 1 CARTONOINTMENT17
51672-1292-1Hydrocortisone Valerate15 g in 1 TUBEOINTMENT157
51672-1292-3Hydrocortisone Valerate1 in 1 CARTONOINTMENT17
51672-1292-3Hydrocortisone Valerate60 g in 1 TUBEOINTMENT607
51672-1292-6Hydrocortisone Valerate1 in 1 CARTONOINTMENT17
51672-1292-6Hydrocortisone Valerate45 g in 1 TUBEOINTMENT457

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1292HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20230129_a9011d6f-6808-48a7-ab6b-df8d40540570.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1292-1GM - Gram51672-1292407b7efb-fe7c-4d99-b7a1-5e52ec45574b12012-07-24
51672-1292-3GM - Gram51672-1292cd408db5-0798-493d-ab8e-b8d9e784a62612012-07-24
51672-1292-6GM - Gram51672-12926849bc3e-4fba-4583-8d73-42a0e921641812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrocortisone ValerateACTIVE INGREDIENT68717P8FUZHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type b (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTHHT01ZNK31HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27EHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
steareth-100INACTIVE INGREDIENT4OH5W9UM87HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
HYDROCORTISONE VALERATEACTIVE INGREDIENT68717P8FUZHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
STEARETH-100INACTIVE INGREDIENT4OH5W9UM87HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1

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 7 of 45 · 883 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
unii: 4T6H12BN9U
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
unii: 4T6H12BN9U
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
unii: T5L8T28FGP
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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