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 8 of 26 · 520 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf0c9494-0138-4346-9348-e235ca4d9e582026-02-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMRetail Business Services, LLC6e9121c8-5eb9-4d0b-86c5-b892e14bdab82026-02-06WarningsExact identifier
unii: 4T6H12BN9U
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf73c618-ed2f-4468-a51f-ff61c7b1f5062026-02-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMSalado Sales Inc.f973e3a5-3b45-4842-99ce-dff676ae1f962026-02-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Petroleum Skin ProtectantWHITE PETROLATUMPharmacy Value Alliance, LLC0ce03cd1-c48d-45cf-b11f-08bade55dcb62026-02-05Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
unii: 4T6H12BN9U
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMHarris Teeterde380df6-cc6e-4b2a-98de-fc08eeb6e8ea2026-02-04Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMHy-Vee, Inc.45867f42-9562-c111-e063-6394a90adb702026-02-04Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Petroleum Skin ProtectantWHITE PETROLATUMMajor Pharmaceuticals0e7e11c5-a1f8-43c4-b8a6-2114910524042026-02-04Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
unii: 4T6H12BN9U
Comforts Petroleum JellyWHITE PETROLATUMKROGER3feb3638-1cdc-62d4-e063-6294a90a1d892026-02-03WarningsExact identifier
unii: 4T6H12BN9U
Petroleum Skin ProtectantWHITE PETROLATUMDemoulas Super Markets, Inc702215f0-4cfd-4a23-b47a-da691c1366342026-02-03Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMKroger Co.b4aa9b58-d95e-4dac-9a34-213482e8ca342026-02-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
OptaseWHITE PETROLATUM, LANOLINScope Health Incc1991caa-51b9-13d1-e053-2995a90a12932026-01-31WarningsExact identifier
unii: 4T6H12BN9U
Lanolin, PetrolatumLANOLIN, PETROLATUMRite Aid Corporation1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d2026-01-30Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec67a1ee-ad71-54f2-e053-2995a90a76902026-01-29WarningsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUM7-Select7e93df71-74bd-4d95-9a64-54756c7b234a2026-01-29Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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