FDA.reportPublic FDA data

NDC 51672-1402-08 - Calcipotriene and Betamethasone 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
51672-1402
Requested NDC
51672-1402-08
Package NDCs from labels
51672-1402-4, 51672-1402-8, 51672-1402-08
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MINERAL OIL - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1402-4Calcipotriene and Betamethasone Dipropionate60 g in 1 BOTTLESUSPENSION602
51672-1402-4Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONSUSPENSION12
51672-1402-8Calcipotriene and Betamethasone Dipropionate60 g in 1 BOTTLESUSPENSION602
51672-1402-8Calcipotriene and Betamethasone Dipropionate2 in 1 CARTONSUSPENSION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1402CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 4 package rows20200904_1d0ab2e6-1ab1-4d3e-ad55-7fa26446f191.zip

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 7 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATECLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEDirect Rxbbf26437-c9b4-d8e6-e053-2a95a90a00622025-01-17Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
unii: T5L8T28FGP
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEAdvanced Rx Pharmacy of Tennessee, LLCfe2ec7d2-23c2-e99f-e053-6294a90aa65a2024-12-31Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
unii: T5L8T28FGP
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
unii: T5L8T28FGP
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
unii: T5L8T28FGP
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
unii: T5L8T28FGP
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact identifier
unii: T5L8T28FGP
Betamethasone dipropionateBETAMETHASONE DIPROPIONATENorthstar Rx LLC.395d40c0-22d9-48d1-8d8e-eeaddf33c53e2024-12-05Adverse reactionsExact identifier
unii: 826Y60901U
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
unii: T5L8T28FGP
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
unii: T5L8T28FGP
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEBurel Pharmaceuticals, LLCc8bda9a8-4dec-4084-84e5-4b4623390bd82024-12-04Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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