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 51 of 53 · 1,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HPNPBERBERIS VULGARIS, CHELIDONIUM MAJUS, KREOSOTUM, NATRUM SULPHURICUM, ORYCTOLAGUS CUNICULUS KIDNEY, ORYCTOLAGUS CUNICULUS PANCREATIN, PHOSPHORICUM ACIDUM, SYZYGIUM JAMBOLANUM, VACCINIUM MYRTILLUSSeroyal USA525694c5-4215-6e87-e054-00144ff8d46c2021-07-22WarningsExact identifier
unii: E4GA8884NN
Passiflora PlexPASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUMSeroyal USA0eabdf34-4d4c-3282-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: E4GA8884NN
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Alclometasone DipropionateALCLOMETASONE DIPROPIONATEGlenmark Pharmaceuticals Inc., USA63e635e0-65d8-4b30-9f2a-ab16deba90bd2021-04-05Adverse reactionsExact identifier
rxcui: 855474
unii: S56PQL4N1V
CAND-EXLYCOPODIUM,NUX VOMICA,BORAX,ASAFOETIDA,NUX MOSCHATA,GENTIANA LUTEA,KREOSOTUM,CALCAREA CARBONICA,SEPIA,PHOSPHORIC ACID,ECHINACEA,PULSATILLA,BAPTISIA,WHITE MANUFACTURING INC. DBA MICRO WEST4d650a1d-c6b5-410e-9e59-3753a373cc222021-01-21WarningsExact identifier
unii: E4GA8884NN
TOTAL ANDRO BALCHOLESTERINUM, DAMIANA, DNA, HYPOTHALAMUS, LECITHIN, PHOSPHORICUM AC, SABALWhite Manufacturing Inc. DBA Micro-Weste0716657-b579-4183-baf6-8d554f9bf1bb2021-01-21WarningsExact identifier
unii: E4GA8884NN
Yin-Yang BalanceADAMAS, AGARICUS MUSC, AGNUS, ALETRIS, ANGELICA SIN, ARG NIT, ARNICA, AVENA, BARYTA, GRAPHITES, KALI BROM, KREOSOTUM, LYCOPODIUM, OCIMUM SANC, PHOSPHORICUM AC, SELENIUM, SEPIA, THUJA OCC.NET Remediesd132b179-01fd-44b6-b3e2-39ffc6d864852021-01-19WarningsExact identifier
unii: E4GA8884NN
WaterACONITUM NAP, ARSENICUM ALB, BORAX, CALC PHOS, GELSENIUM, LYCOPODIUM, PHOSPHORICUM AC, PICRICUM AC, PLUMB MET, SOLIDAGONET Remedies3dc6fdf6-781c-4dec-9aab-a2237fc60c532021-01-19WarningsExact identifier
unii: E4GA8884NN
FireAPIL MEL, BAPTISIA, BARYTA CARB, HAMAMELIS, KALI BROM, KALI PHOS, LACHESIS, LILIUM, PETROLEUM, PHOSPHORICUM AC, SPIGELIA ANTH, SULPHUR, VERATRUM VIRNET Remedies684d7ff2-b241-4c4e-9a16-14c9adfc260f2021-01-19WarningsExact identifier
unii: E4GA8884NN
LibidoDAMIANA, GALIUM, GLANDULA SUPRARENALIS, HEPAR, HYPOPHYSIS, KOREAN GINSENG, NUPHAR, ORCHITINUM, PHOSPHORICUM AC, POPULUS TREM, TESTOSTERONE.ProBlen74669ed9-05c7-410c-95b4-985b92e000bf2021-01-15WarningsExact identifier
unii: E4GA8884NN
Naturasil Cherry AngiomasPHOSPHORICUM ACIDUMNature's Innovationb512f00e-7b3e-4c7b-a0e6-ebffd84b231f2021-01-14WarningsExact identifier
unii: E4GA8884NN
Naturasil Bite ReliefPHOSPHORICUM ACIDUMNature's Innovation, Inc.4a355788-ea13-4323-a55c-d3b1dab8251e2021-01-14WarningsExact identifier
unii: E4GA8884NN
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Naturasil AcnePHOSPHORIC ACIDNature's Innovation, Inc.586619ab-1dfa-4d5c-b886-fedf5eb4c9da2021-01-14WarningsExact identifier
unii: E4GA8884NN
Prime of LifeAGNUS, ALLIUM SATIVUM, AMBRA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., AVENA, BAPTISIA, BARYTA CARB., BRYONIA, CANTHARIS, LACHESIS, LYCOPODIUM, NUX VOM., PHOSPHORICUM AC., PULSATILLA, RUTA, SABAL, SELENIUM, ZINC. MET., GINKGONewton Laboratories, Inc.99751ba5-77c2-2e89-e053-2a95a90a12692020-12-07WarningsExact identifier
unii: E4GA8884NN
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: E4GA8884NN
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
unii: 4T6H12BN9U
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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