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 17 of 21 · 418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunmark Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC58f0b6d7-6072-40fd-ba72-b3ed688347912023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Signature Care Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands, LLC05a63929-fccd-2936-e063-6294a90aeac52023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.a75cac17-c0d1-403a-8a63-80b2d43e31692023-12-12Adverse reactionsExact identifier
unii: 779619577M
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.0d5ca826-d200-42d8-b9c7-d05ecabb6ab22023-12-08Warnings, Adverse reactionsExact identifier
unii: 779619577M
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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