Quick answers
- What is Fluorometholone acetate used for?
- The FDA-approved label (Flarex, Harrow Eye, LLC, March 31, 2025) says: “FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluorometholone acetate 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 Fluorometholone acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluorometholone acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fluorometholone acetate?
- 2 companies list prescription products of Fluorometholone acetate in the FDA NDC Directory, including Harrow Eye, LLC and Eyevance Pharmaceuticals.
What Fluorometholone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
— FDA label: Flarex, Harrow Eye, LLC, effective March 31, 2025. 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 | Suspension/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Flarex |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fluorometholone acetate 1 mg/mL suspension/ drops | Brand: Flarex | $23.95 per mL |
NADAC list of November 4, 2026; these prices took effect on September 23, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Harrow Eye, LLC1 product
- Eyevance Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019079 FLAREX | Harrow Eye | February 11, 1986 | 27, latest September 23, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
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) | 1249629, 1249631 |
|---|---|
| SPL set ID of the quoted label | f060dec4-09dc-4266-ab4c-a6ed49cd8126 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA019079 |
| Active ingredients (FDA) | FLUOROMETHOLONE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Flarex, Harrow Eye, LLC, effective March 31, 2025; 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 →