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 2 of 56 · 1,104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%Bryant Ranch Prepack29113d5e-1570-4fc5-9ce6-a00230e4377e2026-08-27Adverse reactionsExact identifier
unii: 779619577M
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack60f65ee3-b972-4e58-97fe-0c0ab14b9b482026-08-26Adverse reactionsExact identifier
unii: 779619577M
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack7c71c9a8-9c76-4de4-982f-42eb54b7689c2026-08-25Adverse reactionsExact identifier
unii: 779619577M
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack4d9b83e8-593e-4add-ac1d-c8eea25761bc2026-08-25Adverse reactionsExact identifier
unii: 779619577M
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepackfa0e3c04-4b45-4aca-8b59-7df2ec3963e72026-08-25Adverse reactionsExact identifier
unii: 779619577M
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack09717dc5-eef3-4f50-a346-f91d7e86fec92026-08-25Adverse reactionsExact identifier
unii: 779619577M
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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