FDA.reportPublic FDA data

NDC 51311-360 - EASOTIC

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
51311-360
Package NDCs from labels
51311-360-10
Manufacturer
Virbac AH, Inc.
Effective date
2024-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EASOTIC - Virbac AH, Inc.Virbac AH, Inc.2024-07-31PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51311-360-10EASOTIC1 in 1 CARTONSUSPENSION16
51311-360-10EASOTIC10 mL in 1 BOTTLE, PUMPSUSPENSION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51311-360EASOTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]62 package rows20240806_c2346ac2-270f-457b-be1b-152de1dcfdda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVEASOTIC OTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]1
Hydrocortisone aceponateACTIVE INGREDIENT2340UP1L2GEASOTIC OTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]1
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KEASOTIC OTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]1
GentamicinACTIVE MOIETYT6Z9V48IKGEASOTIC OTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]1
Hydrocortisone aceponateACTIVE MOIETY2340UP1L2GEASOTIC OTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]1
MiconazoleACTIVE MOIETY7NNO0D7S5MEASOTIC OTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, AND GENTAMICIN SULFATE) SUSPENSION [VIRBAC AH, INC.]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 12 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care miconazole 7MICONAZOLE NITRATESafeway2e04ac2d-cfbc-4261-a8f9-03715f819c1c2021-02-08WarningsExact identifier
unii: VW4H1CYW1K
Good Neighbor Pharmacy Miconazole 7MICONAZOLE NITRATEAmerisource Bergen5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec2021-01-27WarningsExact identifier
unii: VW4H1CYW1K
Good Sense Miconazole 7MICONAZOLE NITRATEL Perrigo Company4902029e-47dd-483b-af03-b1b5936e98ea2021-01-27WarningsExact identifier
unii: VW4H1CYW1K
good sense miconazole 7MICONAZOLE NITRATEL. Perrigo Company090ee644-7f73-4a43-aa5e-bfa74b0d51302021-01-06WarningsExact identifier
unii: VW4H1CYW1K
Careone miconazole 7MICONAZOLE NITRATEAmerican Sales Companyfced0f7f-31b8-4975-836e-3f38c496a4502021-01-06WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateMICONAZOLE NITRATEActavis Pharma, Inc.aa9e250b-f317-42cb-b8d2-e85de56f4ef72020-10-21Adverse reactionsExact identifier
unii: VW4H1CYW1K
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b44b452d-3630-4cb5-8ed1-1f8edac4690c2018-08-15Warnings, Adverse reactionsExact identifier
unii: VW4H1CYW1K
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b026bc7d-3a18-41e8-88c4-1e063cd2f42c2018-08-14Warnings, Adverse reactionsExact identifier
unii: VW4H1CYW1K
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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