FDA.reportPublic FDA data

NDC 51672-1306-03 - 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
51672-1306-03
Package NDCs from labels
51672-1306-1, 51672-1306-6, 51672-1306-3, 51672-1306-03
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 30 of 53 · 1,047 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: E4GA8884NN
XtraCare Creamy Petroleum JellyPETROLATUMRejoice International6b765967-aead-4f6d-98ee-fac381a40a6e2025-02-11WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum JellyPETROLATUMRejoice Internationaldf367223-b004-42ac-ab3d-23809ebef1b02025-02-11WarningsExact identifier
unii: 4T6H12BN9U
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d22bedb-9f9d-8421-e053-2a95a90acf4a2025-02-10WarningsExact identifier
unii: E4GA8884NN
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d23e5da-4806-8ccc-e053-2995a90a19012025-02-10WarningsExact identifier
unii: E4GA8884NN
PrimeGINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.Newton Laboratories, Inc.9b40f630-0b91-9816-e053-2a95a90a16ec2025-02-10WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM105ACID PHOS, AGNUS CASTUS, CHINA OFF, DAMIANA, IKSHUGANDHA, USTILAGO, PHOSPHOROUSBestmade Natural Products2d8bc5e4-23c7-a3ec-e063-6394a90a280b2025-02-07WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM118ANACARDIUM ORI, ARSENIC ALB, AURUM MUR, KALI BROM, LYCOPODIUM, NATRUM CARB, NATRUM SULPH, PHOSPHORIC ACIDBestmade Natural Products2d90b08b-b65d-7d11-e063-6294a90a50922025-02-07WarningsExact identifier
unii: E4GA8884NN
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Phosphoricum Acidum Kit RefillPHOSPHORIC ACIDWashington Homeopathic Products099254bb-7923-8887-e063-6294a90a2f2e2025-01-28WarningsExact identifier
unii: E4GA8884NN
Geri-Gentle petrolatumWHITE PETROLATUMGeri-gentle corporation0adfbb9e-173c-925a-e063-6394a90aeb5d2025-01-25WarningsExact identifier
unii: 4T6H12BN9U
Endopan HPACETICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, BRYONIA (ALBA), CHROMIUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, SYZYGIUM JAMBOLANUM, THUJA OCCIDENTALIS, URANIUM NITRICUMEnergique, Inc.2bc69a24-c24c-4d12-92bb-7c073edf90dc2025-01-24WarningsExact identifier
unii: E4GA8884NN
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
unii: 4T6H12BN9U
Royal Creamy Petroleum Jelly Cocoa ButterPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Careaca24d5e-42ee-1606-e053-2a95a90ab4e62025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Royal Creamy Petroleum JellyPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Carea903becc-443d-284b-e053-2a95a90a6c752025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Pharmacys Prescription Petroleum JellyPETROLATUMAmerican Consumer Products Corpc4d29ecb-bb00-cb0b-e053-2995a90a37ef2025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
unii: 4T6H12BN9U
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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