FDA.reportPublic FDA data

ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]

RxCUI
1540235
RxNorm name
ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]
Display name
ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]
Full name
ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

RxNav Current And Historical NDCs#

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

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmidriaPHENYLEPHRINE AND KETOROLACOmeros Corporation21470688-4e81-4ea5-ac38-f72e10552e7e2026-04-08Warnings, Adverse reactionsExact identifier
rxcui: 1540235
OmidriaPHENYLEPHRINE AND KETOROLACRayner Surgical Inc.f25d7a42-da2a-7310-e053-2995a90a590f2023-07-07Warnings, Adverse reactionsExact identifier
rxcui: 1540235

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
21470688-4e81-4ea5-ac38-f72e10552e7eOMIDRIA 1 % / 0.3 % Concentrate for Ophthalmic Irrigation Solution [PSN] · ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria] [SBD] · Omidria (ketorolac 0.3 % / phenylephrine 1 % ) Concentrate for Ophthalmic Irrigation Solution [SY] · Omidria (ketorolac tromethamine 4.24 mg/ml (ketorolac 2.88 MG/ML)) / phenylephrine HCl 12.4 mg/ml (phenylephrine 10.16 MG/ML) Concentrate for Ophthalmic Irrigation Solution [SY]416These highlights do not include all the information needed to use OMIDRIA ® safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 201420260408
f25d7a42-da2a-7310-e053-2995a90a590fOMIDRIA 1 % / 0.3 % Concentrate for Ophthalmic Irrigation Solution [PSN] · ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria] [SBD] · Omidria (ketorolac 0.3 % / phenylephrine 1 % ) Concentrate for Ophthalmic Irrigation Solution [SY] · Omidria (ketorolac tromethamine 4.24 mg/ml (ketorolac 2.88 MG/ML)) / phenylephrine HCl 12.4 mg/ml (phenylephrine 10.16 MG/ML) Concentrate for Ophthalmic Irrigation Solution [SY]42These highlights do not include all the information needed to use OMIDRIA ® safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 201420230707