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 4 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Clobetasol PropionateCLOBETASOL PROPIONATETorrent Pharmaceuticals Limited6f930298-e410-4bfb-8c3f-456a1f55f4a92026-05-08Adverse reactionsExact identifier
unii: 779619577M
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
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
rxcui: 1992281
unii: 779619577M
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEEncube Ethicals, Inc.8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf652026-04-21Adverse reactionsExact identifier
unii: 779619577M
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
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
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT, 0.05%Preferred Pharmaceuticals Inc.087c5aee-d7fd-42ce-b213-14c8102928082026-03-30Adverse reactionsExact identifier
unii: 779619577M
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.4a761afb-a48a-4a5a-8700-ad93601a260f2026-03-23Adverse reactionsExact identifier
unii: 779619577M
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEMicro Labs Limited85aea21d-c4ff-4558-b416-516fa93bea1f2026-03-16Adverse reactionsExact identifier
unii: 779619577M

Reported adverse events (FAERS/openFDA)#

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