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 7 of 48 · 941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
unii: 4T6H12BN9U
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
unii: 4T6H12BN9U
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: 4T6H12BN9U
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
unii: 4T6H12BN9U
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
unii: 4T6H12BN9U
Clobetasol PropionateCLOBETASOL PROPIONATETorrent Pharmaceuticals Limited6f930298-e410-4bfb-8c3f-456a1f55f4a92026-05-08Adverse reactionsExact identifier
rxcui: 861495
unii: 779619577M
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 4T6H12BN9U
unii: 2KR89I4H1Y
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
WELL AT WALGREENS BABY ADVANCED HEALINGPETROLATUMWALGREEN COMPANY75067953-4cd8-4fcb-b7b7-dd0d2200642d2026-05-05WarningsExact identifier
unii: 4T6H12BN9U
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
unii: 4T6H12BN9U
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
unii: 4T6H12BN9U
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEGolden State Medical Supply, Inc.04180cdf-c63a-d524-e063-6394a90a2d062026-04-23Adverse reactionsExact identifier
unii: 779619577M
Clobetasol Propionate (emollient)CLOBETASOL PROPIONATEBryant Ranch Prepackcb0bc057-d6ab-4eea-af7a-01661ae9b5172026-04-23Warnings, Adverse reactionsExact identifier
unii: 779619577M

Reported adverse events (FAERS/openFDA)#

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