FDA.reportPublic FDA data

NDC 13985-566 - GenOne

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
13985-566
Package NDCs from labels
13985-566-60, 13985-566-12, 13985-566-24
Manufacturer
MWI | FIRST PRIORITY INCORPORATED
Effective date
2023-09-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GenOne - MWI | FIRST PRIORITY INCORPORATEDMWI | FIRST PRIORITY INCORPORATED2023-09-26PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-566-12GenOne120 mL in 1 BOTTLE, SPRAYSPRAY1207
13985-566-12GenOne12 in 1 CASESPRAY127
13985-566-24GenOne240 mL in 1 BOTTLE, SPRAYSPRAY2407
13985-566-24GenOne12 in 1 CASESPRAY127
13985-566-60GenOne60 mL in 1 BOTTLE, SPRAYSPRAY607
13985-566-60GenOne12 in 1 CASESPRAY127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-566GENONE (GENTAMICIN SULFATE) SPRAY [MWI]76 package rows20230927_83e23b7f-9007-487f-b519-65fb4707fbbc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2GENONE (GENTAMICIN SULFATE) SPRAY [MWI]5
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENONE (GENTAMICIN SULFATE) SPRAY [MWI]5
BETAMETHASONEACTIVE MOIETY9842X06Q6MGENONE (GENTAMICIN SULFATE) SPRAY [MWI]5
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENONE (GENTAMICIN SULFATE) SPRAY [MWI]5

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 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone ValerateBETAMETHASONE VALERATESun Pharmaceutical Industries, Inc.7c96b978-25ff-44c2-bc9c-30ff5e34cffb2026-03-23Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.50d4763d-5a84-4c45-be06-040c4a5274702026-03-19Adverse reactionsExact identifier
unii: 9IFA5XM7R2
BETAMETHASONE VALERATEBETAMETHASONE VALERATEPreferred Pharmaceuticals, Inc.bfa4b6f5-3b66-430a-af41-60e3f12982bc2026-03-19Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin Sulfate Opth SolutionGENTAMICIN SULFATE OPTH SOLUTIONDirect_Rxe1a5bc32-f9a0-6b33-e053-2995a90ab9ac2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
BETAMETHASONE VALERATEBETAMETHASONE VALERATEA-S Medication Solutions7281d272-5342-4738-b35c-42570459e9d42026-02-04Adverse reactionsExact identifier
unii: 9IFA5XM7R2
GentamicinGENTAMICINEugia US LLC60ca1487-392d-4721-aa45-3de38722896c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone ValerateBETAMETHASONE VALERATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0b386ccc-a2d4-4d18-a2d7-e46ff894c6742026-01-28Adverse reactionsExact identifier
unii: 9IFA5XM7R2
GentamicinGENTAMICINEugia US LLCf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEHenry Schein, Inc84f6eb1c-a287-489a-8c3e-aa5954cf19922025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEHenry Schein, Inc.913a36c3-50d6-429a-a8dd-a03126d2ca082025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
BETAMETHASONE VALERATEBETAMETHASONE VALERATESun Pharmaceutical Industries, Inc.3c85be0f-2731-44f1-a18e-d3852d54846f2025-10-02Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Limited75d70e76-023c-4a00-954d-79a697bed80f2025-09-25Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLC3532bb39-a1a6-9d67-e063-6294a90abc0c2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.985d1f62-4bff-4bf1-b7c7-96cb456ef83d2025-02-07Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
BETAMETHASONE VALERATEBETAMETHASONE VALERATEA-S Medication Solutions02db1402-701c-483c-bfd6-8b7a543ae8ef2024-11-11Adverse reactionsExact identifier
unii: 9IFA5XM7R2

Reported adverse events (FAERS/openFDA)#

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