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 31 of 53 · 1,047 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
unii: 4T6H12BN9U
D-4QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.45577059-73f4-4302-b299-3e356aaf959a2025-01-13WarningsExact identifier
unii: E4GA8884NN
D-15ROSA CANINA FRUIT, ANAMIRTA COCCULUS SEED, PHOSPHORIC ACID, CHAMAELIRIUM LUTEUM ROOT, STRYCHNOS IGNATII SEED, ZINC, AND HONEYDNA Labs, Inc.0563477f-1e69-4e08-8c5c-527fe70965972025-01-13WarningsExact identifier
unii: E4GA8884NN
D-26FERROUS IODIDE, PHOSPHORIC ACID, SULFUR IODIDE, CALCIUM IODIDE, AND NITRIC ACIDDNA Labs, Inc.5ef26695-7b71-4c01-a60c-f72dd1fa342d2025-01-13WarningsExact identifier
unii: E4GA8884NN
D-40PHOSPHORIC ACID, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, CLAVICEPS PURPUREA SCLEROTIUM, URANYL NITRATE HEXAHYDRATE, PHASEOLUS VULGARIS WHOLE, AND ARSENIC TRIOXIDEDNA Labs, Inc.8a86c0ee-93e9-48da-a7d8-89225e2331772025-01-13WarningsExact identifier
unii: E4GA8884NN
D-41PHOSPHORIC ACID, CHASTE TREE, CINCHONA OFFICINALIS BARK, TURNERA DIFFUSA LEAFY TWIG, PHOSPHORUS, SEPIA OFFICINALIS JUICE, BOS TAURUS TESTICLE, AND CONIUM MACULATUM FLOWERING TOPDNA Labs, Inc.3600d04a-bab5-440a-a2aa-908bf920620a2025-01-13WarningsExact identifier
unii: E4GA8884NN
D-120CALCIUM FLUORIDE, BISMUTH SUBNITRATE, ZINC, MERCURIC CHLORIDE, TOXICODENDRON PUBESCENS LEAF, ANTIMONY TRISULFIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, IODINE, PHOSPHORIC ACID, POTASSIUM CARBONATE, DIBASIC POTASSIUM PHOSPHATE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.9525c016-f0dd-43fd-a4e9-062075107eec2025-01-13WarningsExact identifier
unii: E4GA8884NN
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
unii: 4T6H12BN9U
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: E4GA8884NN
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
unii: 4T6H12BN9U
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AM-14SILVER, CALCIUM IODIDE, LYTTA VESICATORIA, COPPER, FERROUS IODIDE, GOLDENSEAL, IODINE, DAPHNE MEZEREUM BARK, PHOSPHORIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, AND RUMEX CRISPUS WHOLEDNA Labs, Inc.8bf2fde6-fd71-47f8-b5ec-c5e34857ab642025-01-09WarningsExact identifier
unii: E4GA8884NN
N-11CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, AND BOS TAURUS PROSTATE GLANDDNA Labs, Inc.74b694d7-448d-4509-8bc5-fb1eadca9b252025-01-09WarningsExact identifier
unii: E4GA8884NN
N-12PHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, AND THYROID, UNSPECIFIEDDNA Labs, Inc.89ed00b4-5739-439e-bae9-e00b0b0d72222025-01-09WarningsExact identifier
unii: E4GA8884NN
N-26BARIUM CHLORIDE DIHYDRATE, CONIUM MACULATUM WHOLE, ARNICA MONTANA, PHOSPHORIC ACID, DIBASIC POTASSIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, AND PORK BRAINDNA Labs, Inc.3fb35088-9c43-411f-992f-43b88ff239152025-01-09WarningsExact identifier
unii: E4GA8884NN
N-27ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOPDNA Labs, Inc.df2d7683-3b45-4ddb-9b67-7bb74dad28542025-01-09WarningsExact identifier
unii: E4GA8884NN
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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