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 5 of 26 · 520 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
unii: 4T6H12BN9U
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
unii: 4T6H12BN9U
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Vanilla Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack71bb5177-20af-4aee-ab02-6687c51fe0a12026-03-14WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Mango Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jackbd0f6577-9638-4319-b759-348f357ce3972026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Dreamsicle Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack34e89add-ca63-4b66-bdf5-d47403c917702026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Tropical Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jacka271ec3c-e0ea-4100-9a56-b127bbfef3472026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
unii: 4T6H12BN9U
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMThe Kroger Co.d2095c7b-61ca-40d3-bbf1-04bed4dd789c2026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMWalmart Inc.5893801a-25e1-4750-a55b-d9cddd3f12842026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Skin ProtectantPETROLATUMWalmart Inc.eb836922-f467-42ab-a6e7-b787d97e6c172026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalmart Inc.aa7dbf7f-50be-475b-8140-68be3fa935072026-02-27Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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