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 4 of 48 · 941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
iShancare Hemorrhoid and Fissure CreamISHANCARE HEMORRHOID CREAMShenzhen Ishan Technology Co., Ltd570775ce-a1ed-e57d-e063-6394a90aeeff2026-07-20WarningsExact identifier
unii: 4T6H12BN9U
Ma Ying Long Musk HemorrhoidsPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.af466f21-c4bc-3b89-e053-2995a90a49f22026-07-20WarningsExact identifier
unii: 4T6H12BN9U
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.a83d212b-a970-4ee7-8431-fead6b2e7f9d2026-07-17Warnings, Adverse reactionsExact identifier
unii: 779619577M
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Clobetasol PropionateCLOBETASOL PROPIONATEAvKAREa86241e0-3187-e468-e053-2995a90a1ae52026-07-15Adverse reactionsExact identifier
rxcui: 861495
unii: 779619577M
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
unii: 4T6H12BN9U
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
unii: 4T6H12BN9U
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.d8f560c8-e223-46f0-8afb-b418f2b6399c2026-07-14Warnings, Adverse reactionsExact identifier
unii: 779619577M
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Encube Ethicals, Inc.1f076779-3f76-47d5-99f0-9b0b2d3f5fac2026-07-09Adverse reactionsExact identifier
rxcui: 861448
unii: 779619577M
HOMWIS CreamHOMWIS CREAMShenzhen Ishan Technology Co., Ltd51aeec61-bddd-fea1-e063-6394a90a2e0b2026-07-09WarningsExact identifier
unii: 4T6H12BN9U
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
unii: 4T6H12BN9U
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.91e7bf57-d236-4b9b-8241-e71e5e93617a2026-07-09Warnings, Adverse reactionsExact identifier
unii: 779619577M
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%Encube Ethicals, Inc.bcb76b4b-194d-4cb3-b3ed-26b911df1a112026-07-09Adverse reactionsExact identifier
rxcui: 861495
unii: 779619577M
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
unii: 4T6H12BN9U
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
unii: 4T6H12BN9U
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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