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 2 of 45 · 883 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 4T6H12BN9U
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: T5L8T28FGP
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: GR686LBA74
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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