FDA.reportPublic FDA data

NDC 51672-1297-01 - 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
51672-1297
Requested NDC
51672-1297-01
Package NDCs from labels
51672-1297-1, 51672-1297-2, 51672-1297-3, 51672-1297-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-08-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CETETH-20 - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-08-22HUMAN PRESCRIPTION DRUG LABEL
Clobetasol Propionate - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2018-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1297-1Clobetasol Propionate1 in 1 CARTONCREAM18
51672-1297-1Clobetasol Propionate15 g in 1 TUBECREAM158
51672-1297-2Clobetasol Propionate30 g in 1 TUBECREAM308
51672-1297-2Clobetasol Propionate1 in 1 CARTONCREAM18
51672-1297-3Clobetasol Propionate1 in 1 CARTONCREAM18
51672-1297-3Clobetasol Propionate60 g in 1 TUBECREAM608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1297CLOBETASOL PROPIONATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 6 package rows20250524_91571297-03ad-441e-8ec6-f78c21fbe5e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1297-1GM - Gram51672-129713c4a332-82bb-4378-8e47-07fa1531072412012-07-24
51672-1297-2GM - Gram51672-12978b73fd3a-5f27-42a6-b7a7-d890778268dc12012-07-24
51672-1297-3GM - Gram51672-129722738d19-9474-4df3-a835-4c697a57478e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteth-20INACTIVE INGREDIENTI835H2IHHXCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
imidureaINACTIVE INGREDIENTM629807ATLCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., 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 9 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
clobetasol propionateCLOBETASOL PROPIONATEBryant Ranch Prepack40c3b94f-a61c-4fc1-a411-5bf4e3fe67912025-10-21Warnings, Adverse reactionsExact identifier
unii: 779619577M
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
Clobetasol PropionateCLOBETASOL PROPIONATELupin Pharmaceuticals, Inc.0a267001-0bff-471c-8852-808e6e3ea37c2025-10-14Adverse reactionsExact identifier
unii: 779619577M
Clobetasol PropionateCLOBETASOL PROPIONATELupin Pharmaceuticals, Inc.93f3763f-9f2f-4e81-bf6c-db35af45cd642025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 779619577M
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepackf0ca99cd-6c54-44f8-a9b3-432e93fc5d592025-10-08Adverse reactionsExact identifier
unii: 779619577M
Clobetasol Propionate (emollient)CLOBETASOL PROPIONATEThe J. Molner Company LLC26ccb1d8-c466-e238-e063-6394a90a00692025-10-02Warnings, Adverse reactionsExact identifier
rxcui: 1992281
unii: 779619577M
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack9856b731-0676-405d-817c-de385cbd08a32025-09-30Adverse reactionsExact identifier
unii: 779619577M
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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