FDA.reportPublic FDA data

crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]

RxCUI
1806878
RxNorm name
crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]
Display name
crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]
Full name
crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYTESICROFELEMERNapo Pharmaceuticals, Inc.45584fba-8081-4cd1-a21e-3ea8237f62ff2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1806878

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
45584fba-8081-4cd1-a21e-3ea8237f62ffMytesi 125 MG Delayed Release Oral Tablet [PSN] · crofelemer 125 MG Delayed Release Oral Tablet [Mytesi] [SBD] · Mytesi 125 MG Delayed Release Oral Tablet [SY]37These highlights do not include all the information needed to use MYTESI safely and effectively . See full prescribing information for MYTESI. MYTESI ® (crofelemer) delayed-release tablets for oral use Initial U.S. Approval: 201220251222