FDA.reportPublic FDA data

crofelemer 125 MG Delayed Release Oral Tablet

RxCUI
1364454
RxNorm name
crofelemer 125 MG Delayed Release Oral Tablet
Display name
crofelemer 125 MG Delayed Release Oral Tablet
Full name
crofelemer 125 MG Delayed Release Oral Tablet
Term type
SCD
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#

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 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: 1364454

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
45584fba-8081-4cd1-a21e-3ea8237f62ffcrofelemer 125 MG Delayed Release Oral Tablet [PSN] · crofelemer 125 MG Delayed Release Oral Tablet [SCD]27These 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
9d34804e-ad0d-4f15-8fbd-01ba40cc620fcrofelemer 125 MG Delayed Release Oral Tablet [PSN] · crofelemer 125 MG Delayed Release Oral Tablet [SCD]2520260223