FDA.reportPublic FDA data

loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [Lotemax]

RxCUI
2118539
RxNorm name
loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [Lotemax]
Display name
loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [Lotemax]
Full name
loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [Lotemax]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

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
Lotemax SMLOTEPREDNOL ETABONATEBausch & Lomb Incorporated6f9477b5-699f-4d3b-b9a6-0cc2382662372026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 2118539

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-b9a6-0cc238266237LOTEMAX SM 0.38 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [Lotemax] [SBD] · Lotemax 0.0038 MG/MG Ophthalmic Gel [SY] · Lotemax 0.38 % Ophthalmic Gel [SY]45These 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