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 6 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.e4e9f244-4a85-4c0d-9917-93182c4a6e872025-07-07Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.3b23a3c0-3306-4a2d-932d-25916d16dc682025-07-07Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone dipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.dc3dd2f7-38ad-4c4c-8602-29b33cc6af902025-07-07Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.bc12c828-54ba-411d-b752-9b735f7adf632025-07-02Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.e041ceb2-8bda-4703-b663-804e7b462e322025-07-02Adverse reactionsExact identifier
unii: 826Y60901U
Calcipotriene and Betamethasone DipropionateCALCIPOTRIENE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.1d0ab2e6-1ab1-4d3e-ad55-7fa26446f1912025-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA213269
ndc (package): 51672-1402-4
ndc (package): 51672-1402-8
ndc (product): 51672-1402
ndc11 (package): 51672140208
spl id: 38e5b828-cecd-c95b-e063-6394a90ae2e0
spl set id: 1d0ab2e6-1ab1-4d3e-ad55-7fa26446f191
unii: 143NQ3779B
unii: 826Y60901U
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: T5L8T28FGP
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
unii: T5L8T28FGP
Betamethasone DipropionateBETAMETHASONE DIPROPIONATENuCare Pharmaceuticals,Inc.75862805-2cfc-fb45-e053-2991aa0a14032025-04-03Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone dipropionateBETAMETHASONE DIPROPIONATEA-S Medication Solutions07a35811-7298-4f25-b280-e2f9aeab98302025-04-01Adverse reactionsExact identifier
unii: 826Y60901U
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: T5L8T28FGP
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEA-S Medication Solutions018fcec3-bfb4-451c-9b54-d1fd389c2a442025-03-14Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
unii: T5L8T28FGP
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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