FDA.reportPublic FDA data

Ameluz 10 % Topical Gel

RxCUI
1806650
RxNorm name
Ameluz 10 % Topical Gel
Display name
Ameluz 10 % Topical Gel
Full name
Ameluz 10 % Topical Gel
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMELUZAMINOLEVULINIC ACID HYDROCHLORIDEBiofrontera Inc.650daa9f-aeec-49ce-95b9-5fa20b988afd2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 1806650

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
650daa9f-aeec-49ce-95b9-5fa20b988afdAmeluz 10 % Topical Gel [PSN] · aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel [Ameluz] [SBD] · Ameluz 0.1 MG/MG Topical Gel [SY] · Ameluz 10 % Topical Gel [SY]431These highlights do not include all the information needed to use AMELUZ safely and effectively. See full prescribing information for AMELUZ. AMELUZ ® (aminolevulinic acid hydrochloride) topical gel Initial U.S. Approval: 199920251222