FDA.reportPublic FDA data

NDC 51672-5263-01 - Topicort

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
51672-5263
Requested NDC
51672-5263-01
Package NDCs from labels
51672-5263-5, 51672-5263-1, 51672-5263-2, 51672-5263-3, 51672-5263-7, 51672-5263-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topicort ® (Desoximetasone Ointment USP) 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-03-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5263-1Topicort1 in 1 CARTONOINTMENT111
51672-5263-1Topicort15 g in 1 TUBEOINTMENT1511
51672-5263-2Topicort1 in 1 CARTONOINTMENT111
51672-5263-2Topicort30 g in 1 TUBEOINTMENT3011
51672-5263-3Topicort1 in 1 CARTONOINTMENT111
51672-5263-3Topicort60 g in 1 TUBEOINTMENT6011
51672-5263-5Topicort5 g in 1 TUBEOINTMENT511
51672-5263-5Topicort10 in 1 CARTONOINTMENT1011
51672-5263-7Topicort100 g in 1 TUBEOINTMENT10011
51672-5263-7Topicort1 in 1 CARTONOINTMENT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5263TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 10 package rows20241222_96dfac6f-540f-4b7d-bcee-7e62088ebc93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5263-1GM - Gram51672-526306effd42-563e-4fab-a370-fa1482018d9612012-07-24
51672-5263-3GM - Gram51672-5263426dbc17-a78e-45d8-a8b7-fe8ee1cd646d12012-07-24
51672-5263-7GM - Gram51672-5263634035fc-db06-4358-86b0-1a858182151612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
DesoximetasoneACTIVE MOIETY4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7

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 18 of 31 · 605 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
unii: 4T6H12BN9U
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: 4T6H12BN9U
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
unii: T5L8T28FGP
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: 4T6H12BN9U
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
unii: 4T6H12BN9U
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
unii: 4T6H12BN9U
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.b046ab97-ba1a-4be6-a238-09670b38b3972025-07-08Warnings, Adverse reactionsExact identifier
unii: 4E07GXB7AU
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
unii: 4T6H12BN9U
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
unii: 4T6H12BN9U
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.627031fc-9b91-4854-b08f-f9fc0c73f1de2025-07-03Warnings, Adverse reactionsExact identifier
unii: 4E07GXB7AU
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.96898d55-aa50-4281-8c23-ec4738ede3942025-07-03Warnings, Adverse reactionsExact identifier
application number: NDA018594
rxcui: 141850
unii: 4E07GXB7AU
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: 4T6H12BN9U
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.37eb1205-1743-4480-8631-b0bbcaeb83592025-07-02Warnings, Adverse reactionsExact identifier
unii: 4E07GXB7AU
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.e417856a-b760-4626-bc34-8e4bc62c026c2025-07-02Warnings, Adverse reactionsExact identifier
unii: 4E07GXB7AU
Walgreens Healing Balm Skin ProtectantPETROLATUMWalgreensbc585145-3588-446e-926f-e6baf43ca4ba2025-06-24WarningsExact identifier
unii: 4T6H12BN9U
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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