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 8 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone dipropionateBETAMETHASONE DIPROPIONATEZydus Lifesciences Limitedbc9ca1f4-8f40-44e1-bb2d-42ecba35d4062024-11-25Exact identifier
unii: 826Y60901U
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
unii: T5L8T28FGP
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
unii: T5L8T28FGP
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
unii: T5L8T28FGP
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
unii: T5L8T28FGP
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
unii: T5L8T28FGP
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
unii: T5L8T28FGP
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEAsclemed USA, Inc86994546-929c-4303-89e4-31ba271673cf2024-10-11Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
unii: T5L8T28FGP
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: T5L8T28FGP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: T5L8T28FGP
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions4320f2b8-ac47-40f4-9275-e7c5506e30e42024-09-11Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEBryant Ranch Prepackd6702ddc-4a1d-4d0d-bebd-bc615ed0bc352024-08-30Adverse reactionsExact identifier
unii: 826Y60901U
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEActavis Pharma, Inc.a6ac4020-2c67-426a-8289-7e54ce43d0c92024-08-27Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 1P9D0Z171K
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepack0481ac0d-9220-472b-b3f2-af6e0bb6962d2024-08-20Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
unii: T5L8T28FGP
calcipotriene and betamethasone dipropionateCALCIPOTRIENE AND BETAMETHASONE DIPROPIONATECosette Pharmaceuticals, Inc.1eba330b-ce18-6b12-e063-6294a90a87632024-08-13Warnings, Adverse reactionsExact identifier
unii: 143NQ3779B
unii: 826Y60901U

Reported adverse events (FAERS/openFDA)#

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