FDA.reportPublic FDA data

NDC 51672-1316-01 - 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
51672-1316
Requested NDC
51672-1316-01
Package NDCs from labels
51672-1316-5, 51672-1316-1, 51672-1316-6, 51672-1316-3, 51672-1316-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alclometasone Dipropionate Ointment USP, 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-08-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1316-1Alclometasone Dipropionate15 g in 1 TUBEOINTMENT156
51672-1316-1Alclometasone Dipropionate1 in 1 CARTONOINTMENT16
51672-1316-3Alclometasone Dipropionate60 g in 1 TUBEOINTMENT606
51672-1316-3Alclometasone Dipropionate1 in 1 CARTONOINTMENT16
51672-1316-5Alclometasone Dipropionate5 g in 1 TUBEOINTMENT56
51672-1316-6Alclometasone Dipropionate45 g in 1 TUBEOINTMENT456
51672-1316-6Alclometasone Dipropionate1 in 1 CARTONOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1316ALCLOMETASONE DIPROPIONATE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 7 package rows20250406_3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1316-1GM - Gram51672-1316e1f2381a-616f-4b9d-95db-c95793d07b1c12012-07-24
51672-1316-3GM - Gram51672-1316f55a994a-f1ed-4b3c-8a65-bc03913f385212012-07-24
51672-1316-6GM - Gram51672-1316e5eb658f-bc10-4590-9ebd-4d373c3c1b1912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Alclometasone dipropionateACTIVE INGREDIENTS56PQL4N1VALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
AlclometasoneACTIVE MOIETY136H45TB7BALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycol monostearateINACTIVE INGREDIENTF76354LMGRALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

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 9 of 26 · 520 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare49132a75-4a16-cede-e063-6294a90a62172026-01-29WarningsExact identifier
unii: 4T6H12BN9U
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMAldi, Inc94fea2f2-fea8-4923-afc6-36068bc2fef52026-01-29Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC066b1313-aed8-9436-e063-6294a90a2b112026-01-29WarningsExact identifier
unii: 4T6H12BN9U
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
unii: 4T6H12BN9U
VERADEX-EPETROLATUM AND LANOLINABBE Laboratories, Inc.00100102-c245-4b63-a4ff-794cacda6f172026-01-24WarningsExact identifier
unii: 4T6H12BN9U
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
unii: 4T6H12BN9U
Designer Lip Smoothie SPF 15 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMAustralian Gold6fd1bd4f-ef94-42b5-a26c-2a02718c113f2026-01-22WarningsExact identifier
unii: 4T6H12BN9U
Australian Gold SPF 15 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYAustralian Gold92966c2d-b61a-4f8b-a5c1-8dfb6352c82f2026-01-22WarningsExact identifier
unii: 4T6H12BN9U
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Gold32725ca7-ec21-4643-bdc6-278fd647b95d2026-01-21WarningsExact identifier
unii: 4T6H12BN9U
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Golde6877f7a-3aaa-4096-bcb5-eae0aa2532e52026-01-21WarningsExact identifier
unii: 4T6H12BN9U
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: 4T6H12BN9U
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
unii: 4T6H12BN9U
Walgreens Vitamin A and D skin protectantLANOLIN, PETROLATUMWalgreen Company9aa6c7f2-0923-4d51-8b9b-63f9a724937a2026-01-15WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: 4T6H12BN9U
MEDPURA Vitamin A and D Vitamin A and DMEDPURA VITAMIN A AND DAkron Pharma Inc.38cc2317-691b-4657-af05-c67623eba7602026-01-14WarningsExact identifier
unii: 4T6H12BN9U
Walgreens Baby PetroleumPETROLATUMWalgreen Companye79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d2026-01-14WarningsExact identifier
unii: 4T6H12BN9U
Walgreens Cocoa Butter JellyPETROLEUMWalgreens32b84286-471a-4d15-80fb-2f516dc1d6ea2026-01-14WarningsExact identifier
unii: 4T6H12BN9U
Hydrating Healing Skin ProtectantPETROLATUM OINTMENTCVS Pharmacyc129c2b0-10d5-4b5d-ac5c-2e2512e612792026-01-14WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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