FDA.reportPublic FDA data

NDC 51672-1350-08 - 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
51672-1350
Requested NDC
51672-1350-08
Package NDCs from labels
51672-1350-4, 51672-1350-8, 51672-1350-08
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DIMETHICONE - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL
Clobetasol Propionate - REMEDYREPACK INC.REMEDYREPACK INC.2022-03-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1350-4Clobetasol Propionate1 in 1 CARTONLOTION18
51672-1350-4Clobetasol Propionate59 mL in 1 BOTTLELOTION598
51672-1350-8Clobetasol Propionate1 in 1 CARTONLOTION18
51672-1350-8Clobetasol Propionate118 mL in 1 BOTTLELOTION1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1350CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 4 package rows20241222_d4c73fb0-9675-4c41-a8bd-dd4cb2db1169.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1350-4ML - Milliliter51672-1350e9248315-e443-4d7e-9300-43846b6e7d3312013-02-13
51672-1350-8ML - Milliliter51672-13500472f0f0-2b18-46ba-b4a0-860547739af512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clobetasol propionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)INACTIVE INGREDIENTZ135WT9208CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPCLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]3
white waxINACTIVE INGREDIENT7G1J5DA97FCLOBETASOL PROPIONATE LOTION [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 5 of 55 · 1,093 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
unii: 92RU3N3Y1O
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
unii: 92RU3N3Y1O
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
unii: 92RU3N3Y1O
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
unii: 92RU3N3Y1O
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
unii: 92RU3N3Y1O
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.a83d212b-a970-4ee7-8431-fead6b2e7f9d2026-07-17Warnings, Adverse reactionsExact identifier
unii: 779619577M
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Clobetasol PropionateCLOBETASOL PROPIONATEAvKAREa86241e0-3187-e468-e053-2995a90a1ae52026-07-15Adverse reactionsExact identifier
unii: 779619577M
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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