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 17 of 31 · 605 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedPride Vitamin A and DWHITE PETROLATUMShield Line LLC360085ae-29fc-41c9-9875-c902f197a8712025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Petrolatum with Cocoa ButterPETROLATUMShield line LLC3e9c68e5-8983-1a18-e054-00144ff8d46c2025-08-18WarningsExact identifier
unii: 4T6H12BN9U
MedprideWHITE PETROLATUMShield Line LLC0c4201e1-54f5-4d44-a31a-89aaa511d6b52025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Baby Petrolatum JellyPETROLATUMShield Line LLC3e9cf8bf-929b-45bf-e054-00144ff8d46c2025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
unii: 4T6H12BN9U
Aloe Vera Petrolatum JellyPETROLATUMShield Line LLCfdf3b90e-a434-49b2-e053-6394a90ab1752025-08-15WarningsExact identifier
unii: 4T6H12BN9U
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
unii: 4T6H12BN9U
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
unii: 4T6H12BN9U
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
StyeMINERAL OIL AND PETROLATUMInsight Pharmaceuticals LLCf7eb8466-d8ea-4833-9bed-244ead38a3bf2025-08-11WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: 4T6H12BN9U
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact identifier
unii: 4T6H12BN9U
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
unii: 4T6H12BN9U
AsteroidMENTHOL, PETROLATUM, ZINC OXIDEHEALTHTEX LIMITED29d1e46d-0189-4f9e-9963-8a9de2757f282025-07-30WarningsExact identifier
unii: 4T6H12BN9U
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
unii: T5L8T28FGP
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
unii: 4T6H12BN9U
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
unii: 4T6H12BN9U
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
unii: 4T6H12BN9U
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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