Quick answers
- What is Phenylephrine and ketorolac used for?
- The FDA-approved label (Omidria, Omeros Corporation, April 8, 2026) says: “Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Phenylephrine and ketorolac have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Phenylephrine and ketorolac?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Phenylephrine and ketorolac been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Phenylephrine and ketorolac?
- 2 companies list prescription products of Phenylephrine and ketorolac in the FDA NDC Directory, including Omeros Corporation and Rayner Surgical Inc..
What Phenylephrine and ketorolac is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for …
— FDA label: Omidria, Omeros Corporation, effective April 8, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate |
|---|---|
| Route | Intraocular |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Omidria |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Omeros Corporation1 product
- Rayner Surgical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA205388 OMIDRIA | Rayner Surgical | May 30, 2014 | 5, latest December 8, 2017 2017: Efficacy · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1540230, 1540235 |
|---|---|
| SPL set ID of the quoted label | 21470688-4e81-4ea5-ac38-f72e10552e7e |
| FDA labels (SPL) | 2 |
| FDA applications | NDA205388 |
| Active ingredients (FDA) | KETOROLAC / PHENYLEPHRINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Omidria, Omeros Corporation, effective April 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →