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 3 of 48 · 941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepackd6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae22026-08-07Adverse reactionsExact identifier
rxcui: 861448
unii: 779619577M
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack032f1f4e-1f1c-409a-8fac-6449ee543caa2026-08-07Adverse reactionsExact identifier
rxcui: 861448
unii: 779619577M
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
unii: 4T6H12BN9U
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack3dcc49e7-a4f8-44cf-9405-2786bdc910cb2026-08-06Adverse reactionsExact identifier
rxcui: 861448
unii: 779619577M
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
unii: 4T6H12BN9U
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
unii: 4T6H12BN9U
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
unii: 4T6H12BN9U
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
unii: 4T6H12BN9U
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
unii: 4T6H12BN9U
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
unii: 4T6H12BN9U
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
unii: 4T6H12BN9U
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
unii: 4T6H12BN9U
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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