FDA.reportPublic FDA data

NDC 51672-1306-01 - Alclometasone dipropionate

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
51672-1306
Requested NDC
51672-1306-01
Package NDCs from labels
51672-1306-1, 51672-1306-6, 51672-1306-3, 51672-1306-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alclometasone Dipropionate Cream USP, 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1306-1Alclometasone dipropionate1 in 1 CARTONCREAM18
51672-1306-1Alclometasone dipropionate15 g in 1 TUBECREAM158
51672-1306-3Alclometasone dipropionate1 in 1 CARTONCREAM18
51672-1306-3Alclometasone dipropionate60 g in 1 TUBECREAM608
51672-1306-6Alclometasone dipropionate1 in 1 CARTONCREAM18
51672-1306-6Alclometasone dipropionate45 g in 1 TUBECREAM458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1306ALCLOMETASONE DIPROPIONATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 6 package rows20250406_3e688309-880a-4890-bf00-90afd19084f6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1306-1GM - Gram51672-1306e34439b7-f57c-447f-bb87-7b7768d05f8f12012-07-24
51672-1306-3GM - Gram51672-13063dd20574-f5c1-46b9-a0d9-f367fbfc630312012-07-24
51672-1306-6GM - Gram51672-1306b4b75d89-ff90-49b6-ae25-b9b2a536532512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Alclometasone dipropionateACTIVE INGREDIENTS56PQL4N1VALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
AlclometasoneACTIVE MOIETY136H45TB7BALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Ceteth-20INACTIVE INGREDIENTI835H2IHHXALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
chlorocresolINACTIVE INGREDIENT36W53O7109ALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4ALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Peg-100 StearateINACTIVE INGREDIENTYD01N1999RALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
phosphoric acidINACTIVE INGREDIENTE4GA8884NNALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YALCLOMETASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RALCLOMETASONE DIPROPIONATE 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 42 of 53 · 1,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
unii: 4T6H12BN9U
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Diathesis V 2GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, CYSTEINUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, BARYTA CARBONICA, FUMARICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORICUM ACIDUM, PHOSPHORUSBioActive Nutritional, Inc.1f389621-b22b-4d6c-9c28-93292eb4eebf2024-02-13WarningsExact identifier
unii: E4GA8884NN
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
unii: 4T6H12BN9U
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
unii: 4T6H12BN9U
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
unii: 4T6H12BN9U
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
unii: 4T6H12BN9U
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
unii: 4T6H12BN9U
EA EIGHT HR LIP SHEER TINTSOXYBENZONE, PADIMATE O, PETROLATUMREVLONb671d630-2b71-66d2-e053-2a95a90a84612024-01-12WarningsExact identifier
unii: 4T6H12BN9U
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: E4GA8884NN
B13 CELL SALT COMPLEXALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENSApex Energetics Inc.bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d2024-01-08WarningsExact identifier
unii: E4GA8884NN
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: E4GA8884NN
B06 Stress ResistanceAVENA SATIVA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COFFEA CRUDA, ENGLISH OAK, ESCHSCHOLTZIA CALIFORNICA, EUROPEAN HORNBEAM, FICUS CARICA, HUMULUS LUPULUS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, KALI PHOSPHORICUM, KALI SILICATUM, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PYRENEES STAR OF BETHLEHEM, ROCKROSE, SUS SCROFA PARASYMPATHETIC NERVE, PINEAL GLAND, SYMPATHETIC NERVE, VALERIANA OFFICINALIS, VERBENA OFFICINALIS, ZINCUM VALERIANICUMApex Energetics Inc.baeb5252-49b5-149c-e053-2995a90a20002024-01-08WarningsExact identifier
unii: E4GA8884NN
B02 ADRENAL PEPACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUMApex Energetics Inc.bad63b2e-63b4-ee97-e053-2a95a90a82e42024-01-08WarningsExact identifier
unii: E4GA8884NN
E08 BIOCLOCK REGULATORBETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINEApex Energetics Inc.bf77d8e4-cf1c-447f-e053-2995a90a8c6f2024-01-08WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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