FDA.reportPublic FDA data

NDC 0986-0813 - Surolan

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
0986-0813
Package NDCs from labels
0986-0813-15, 0986-0813-30
Manufacturer
ELANCO ANIMAL HEALTH CO | Olon SpA | Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A., | EuroAPI France | Xellia Pharmaceuticals ApS
Effective date
2022-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Surolan™ELANCO ANIMAL HEALTH CO | Olon SpA | Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A., | EuroAPI France | Xellia Pharmaceuticals ApS2022-09-30PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KSUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4SUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
PREDNISOLONE ACETATEACTIVE INGREDIENT8B2807733DSUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MSUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KSUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMSUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO ANIMAL HEALTH CO]1

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 9 of 31 · 610 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d380fe4-a870-cb55-e063-6394a90a9c902026-01-28WarningsExact identifier
unii: VW4H1CYW1K
Foot PowderMICONAZOLE NITRATEWalgreens Company137a493b-6ed5-d649-e063-6294a90ac4422026-01-28WarningsExact identifier
unii: VW4H1CYW1K
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMREMEDYREPACK INC.2a040ba4-54bd-41e4-b519-01ca6a59658f2026-01-27Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4963f926-3d48-36de-e063-6294a90a9acc2026-01-27WarningsExact identifier
unii: 19371312D4
Miconazole NitrateJOCK ITCH SPRAYWal-Mart Stores, Inc.76259769-9923-4856-a160-a738bc8a72f02026-01-27WarningsExact identifier
unii: VW4H1CYW1K
Drs. Pharmacy Triple Antibiotic AND BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOL PHARMA TECH, LLC Drs PHARMACY4928d9dd-542b-fe8b-e063-6294a90a92522026-01-22WarningsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c3b6004a-8cfc-d5f8-e053-2a95a90a3efb2026-01-21Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Miconazole NitrateMICONAZOLE NITRATEAvKARE1a26534d-eeb8-8d17-e063-6294a90a70c72026-01-19WarningsExact identifier
unii: VW4H1CYW1K
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEPreferred Pharmaceuticals Inc.e42d4837-77c2-40c3-8705-20966a51a8222026-01-19Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Lotrimin AntifungalMICONAZOLE NITRATEBayer HealthCare LLC.cebd222c-074f-443c-bd37-612114b27bbd2026-01-16WarningsExact identifier
unii: VW4H1CYW1K
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer HealthCare LLC.1300d84f-d7ff-ec57-e063-6294a90ae0de2026-01-16WarningsExact identifier
unii: VW4H1CYW1K
Antifungal Ringworm TreatmentMICONAZOLE NITRATERida LLCeb953281-cf86-44cf-a3d1-37b8d344a6bc2026-01-15WarningsExact identifier
unii: VW4H1CYW1K
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
unii: VW4H1CYW1K
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEA-S Medication Solutions19b4cfab-5927-47c5-a032-58ab2998d9c72026-01-13Warnings, Adverse reactionsExact identifier
unii: 19371312D4
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
unii: VW4H1CYW1K
Zeasorb Jock ItchMICONAZOLE NITRATECrown Laboratories09d088ef-aab3-5565-e063-6394a90af2632026-01-12WarningsExact identifier
unii: VW4H1CYW1K
Zeasorb Athletes FootMICONAZOLE NITRATECrown Laboratories09bb313e-90cb-5629-e063-6294a90ac2682026-01-12WarningsExact identifier
unii: VW4H1CYW1K
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsExact identifier
unii: VW4H1CYW1K
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEREMEDYREPACK INC.04fe1b32-adfb-4c36-a986-d81b49497e0f2026-01-12Warnings, Adverse reactionsExact identifier
unii: 19371312D4
miconazole nitrateMICONAZOLE NITRATEAvPAKeaf016f6-b631-af00-e053-2a95a90adc7b2026-01-09WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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