FDA.reportPublic FDA data

Xtoro 0.3 % Otic Suspension

RxCUI
1598650
RxNorm name
Xtoro 0.3 % Otic Suspension
Display name
Xtoro 0.3 % Otic Suspension
Full name
Xtoro 0.3 % Otic Suspension
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTOROFINAFLOXACINFonseca Biosciences, LLC5c628272-019e-4511-8d5c-dcf56023da252026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 1598650

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5c628272-019e-4511-8d5c-dcf56023da25Xtoro 0.3 % Otic Suspension [PSN] · finafloxacin 3 MG/ML Otic Suspension [Xtoro] [SBD] · Xtoro 0.3 % Otic Suspension [SY] · Xtoro 3 MG/ML Otic Suspension [SY]41These highlights do not include all the information needed to use XTORO safely and effectively. See full prescribing information for XTORO. XTORO (finafloxacin otic suspension) 0.3%, for topical otic use Initial U.S. Approval: 201420260324