FDA.reportPublic FDA data

tizanidine 0.4 MG/ML Oral Solution [Ontralfy]

RxCUI
2709438
RxNorm name
tizanidine 0.4 MG/ML Oral Solution [Ontralfy]
Display name
tizanidine 0.4 MG/ML Oral Solution [Ontralfy]
Full name
tizanidine 0.4 MG/ML Oral Solution [Ontralfy]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

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
OntralfyTIZANIDINE HYDROCHLORIDERosemont Pharmaceuticals, LLC7b88c338-c0b7-4c08-bef6-a4ffc2f25df72025-10-25Warnings, Adverse reactionsExact identifier
rxcui: 2709438

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
7b88c338-c0b7-4c08-bef6-a4ffc2f25df7Ontralfy 2 MG in 5 mL Oral Solution [PSN] · tizanidine 0.4 MG/ML Oral Solution [Ontralfy] [SBD] · Ontralfy 0.4 MG/ML Oral Solution [SY] · Ontralfy 2 MG per 5 mL Oral Solution [SY]42These highlights do not include all the information needed to use ONTRALFY™ safely and effectively. See full prescribing information for ONTRALFY. ONTRALFY™ (tizanidine oral solution) Initial U.S. Approval: 199620251025