FDA.reportPublic FDA data

NDC 51672-1306-06 - 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
51672-1306-06
Package NDCs from labels
51672-1306-1, 51672-1306-6, 51672-1306-3, 51672-1306-06
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 44 of 53 · 1,047 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
unii: 4T6H12BN9U
AltalubeMINERAL OIL AND PETROLATUMAltaire Pharmaceuticals Inc.eb65004c-c3a7-4079-bd75-f2857d30c68a2023-12-09WarningsExact identifier
unii: 4T6H12BN9U
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
unii: 4T6H12BN9U
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf2023-12-05WarningsExact identifier
unii: 4T6H12BN9U
Welmedix HomeCare PRO Extra Strength Rapid Rash ReliefPETROLATUM, ZINC OXIDEWelmedix LLC551e6cce-7adc-4e98-baff-2703b83d75262023-12-05WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
unii: 4T6H12BN9U
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
unii: 4T6H12BN9U
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
unii: 4T6H12BN9U
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: E4GA8884NN
Sun X SPF 50 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMCoreTex Products, INCc0355990-b842-47cd-e053-2a95a90a7c822023-11-20WarningsExact identifier
unii: 4T6H12BN9U
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: E4GA8884NN
UNIVERSAL ORIGINAL PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC47b8c720-ad1e-4ac7-ba73-872e409b38bf2023-11-17WarningsExact identifier
unii: 4T6H12BN9U
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC1ac9ee69-339d-4426-b3bf-13e5386f1a9b2023-11-17WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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