FDA.reportPublic FDA data

loteprednol etabonate 0.38 % Ophthalmic Gel

RxCUI
2118537
RxNorm name
loteprednol etabonate 0.38 % Ophthalmic Gel
Display name
loteprednol etabonate 0.38 % Ophthalmic Gel
Full name
loteprednol etabonate 0.38 % Ophthalmic Gel
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

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No records found.

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
Lotemax SMLOTEPREDNOL ETABONATEBausch & Lomb Incorporated6f9477b5-699f-4d3b-b9a6-0cc2382662372026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 2118537

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
6f9477b5-699f-4d3b-b9a6-0cc238266237loteprednol etabonate 0.38 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [SCD] · loteprednol etabonate 0.38 % Ophthalmic Gel [SY]35These highlights do not include all the information needed to use LOTEMAX ® SM safely and effectively. See full prescribing information for LOTEMAX ® SM. LOTEMAX ® SM (loteprednol etabonate ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 199820260331