FDA.reportPublic FDA data

fluorouracil 40 MG/ML Topical Cream

RxCUI
1669868
RxNorm name
fluorouracil 40 MG/ML Topical Cream
Display name
fluorouracil 40 MG/ML Topical Cream
Full name
fluorouracil 40 MG/ML Topical Cream
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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No records found.

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
TOLAKFLUOROURACILHILL DERMACEUTICALS, INC.59de2709-00b8-4f0a-867c-f0dfeb9471922022-09-06Warnings, Adverse reactionsExact identifier
rxcui: 1669868

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
59de2709-00b8-4f0a-867c-f0dfeb947192fluorouracil 4 % Topical Cream [PSN] · fluorouracil 40 MG/ML Topical Cream [SCD] · 5-5-fluorouracil 40 MG/ML Topical Cream [SY] · 5-FU 40 MG/ML Topical Cream [SY] · fluorouracil 4 % Topical Cream [SY]56These highlights do not include all the information needed to use TOLAK CREAM safely and effectively. See full prescribing information for TOLAK CREAM. TOLAK (fluorouracil) Cream, 4%, for topical use Initial U.S. Approval: 196220220906