FDA.reportPublic FDA data

NDC 51672-1259-01 - Clobetasol Propionate

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
51672-1259
Requested NDC
51672-1259-01
Package NDCs from labels
51672-1259-1, 51672-1259-2, 51672-1259-6, 51672-1259-3, 51672-1259-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-03-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clobetasol Propionate Gel, 0.05% Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Ointment USP, 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceutical Industries Ltd.2026-03-23HUMAN PRESCRIPTION DRUG LABEL
Clobetasol Propionate - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-01-31HUMAN PRESCRIPTION DRUG LABEL
Clobetasol Propionate - REMEDYREPACK INC.REMEDYREPACK INC.2022-07-13HUMAN PRESCRIPTION DRUG LABEL
Clobetasol Propionate - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-12-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1259-1Clobetasol Propionate15 g in 1 TUBEOINTMENT1511
51672-1259-1Clobetasol Propionate1 in 1 CARTONOINTMENT111
51672-1259-2Clobetasol Propionate1 in 1 CARTONOINTMENT111
51672-1259-2Clobetasol Propionate30 g in 1 TUBEOINTMENT3011
51672-1259-3Clobetasol Propionate1 in 1 CARTONOINTMENT111
51672-1259-3Clobetasol Propionate60 g in 1 TUBEOINTMENT6011
51672-1259-6Clobetasol Propionate45 g in 1 TUBEOINTMENT4511
51672-1259-6Clobetasol Propionate1 in 1 CARTONOINTMENT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1259CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]8Current NDC, Legacy NDC, 8 package rows20230519_4a761afb-a48a-4a5a-8700-ad93601a260f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1259-1GM - Gram51672-12591edafb20-ace9-4aff-91f0-96d63e5f6ba812012-07-24
51672-1259-2GM - Gram51672-1259560262b0-91c0-40f7-a77c-8ed40a1a421f12012-07-24
51672-1259-3GM - Gram51672-1259afdee0ff-9c78-4445-af03-d59f69c6bffb12012-07-24
51672-1259-6GM - Gram51672-1259de68aa96-175b-49c9-bf6c-612c034371b712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
chlorocresolINACTIVE INGREDIENT36W53O7109CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
petrolatumINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
sorbitan sesquioleateINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
white waxINACTIVE INGREDIENT7G1J5DA97FCLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, 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 8 of 48 · 941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEEncube Ethicals, Inc.8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf652026-04-21Adverse reactionsExact identifier
unii: 779619577M
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
unii: 4T6H12BN9U
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
unii: 4T6H12BN9U
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEA-S Medication Solutionsc26e6e8f-9670-48c5-917b-e73e5589579a2026-04-14Adverse reactionsExact identifier
unii: 779619577M
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
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
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
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT, 0.05%Preferred Pharmaceuticals Inc.087c5aee-d7fd-42ce-b213-14c8102928082026-03-30Adverse reactionsExact identifier
rxcui: 861448
unii: 779619577M
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
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
unii: 4T6H12BN9U
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.4a761afb-a48a-4a5a-8700-ad93601a260f2026-03-23Adverse reactionsExact identifier
application number: ANDA074249
application number: ANDA075279
application number: ANDA074248
ndc (package): 51672-1259-2
ndc (package): 51672-1258-1
ndc (package): 51672-1258-2
ndc (package): 51672-1259-1
ndc (package): 51672-1258-6
ndc (package): 51672-1294-3
ndc (package): 51672-1294-2
ndc (package): 51672-1259-3
ndc (package): 51672-1259-6
ndc (package): 51672-1294-1
ndc (package): 51672-1258-3
ndc (product): 51672-1259
ndc (product): 51672-1258
ndc (product): 51672-1294
ndc11 (package): 51672125901
rxcui: 861495
rxcui: 861448
rxcui: 861434
spl id: 4db5c318-4c64-4e2c-e063-6294a90aa7f9
spl set id: 4a761afb-a48a-4a5a-8700-ad93601a260f
unii: 779619577M

Reported adverse events (FAERS/openFDA)#

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