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 5 of 45 · 883 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Drs. Pharmacy healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY55947cd9-ca25-0844-e063-6294a90a381f2026-07-01WarningsExact identifier
unii: 4T6H12BN9U
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 4T6H12BN9U
unii: 2KR89I4H1Y
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
unii: 4T6H12BN9U
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
unii: 4T6H12BN9U
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS Healing Balm Skin ProtectantPETROLATUMCVSdf711f93-71bd-4fbe-835c-50eaa9c15e072026-06-15WarningsExact identifier
unii: 4T6H12BN9U
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
unii: 4T6H12BN9U
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
unii: 4T6H12BN9U
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: 4T6H12BN9U
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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