Quick answers
- What is Flunisolide used for?
- The FDA-approved label (Flunisolide, Oceanside Pharmaceuticals, May 2, 2025) says: “Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Flunisolide have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Flunisolide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Flunisolide been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 30, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Flunisolide?
- 3 companies list prescription products of Flunisolide in the FDA NDC Directory, including Bausch & Lomb Incorporated, Oceanside Pharmaceuticals and Ingenus Pharmaceuticals, LLC.
What Flunisolide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.
— FDA label: Flunisolide, Oceanside Pharmaceuticals, effective May 2, 2025. Read the full label on DailyMed →
The FDA has 3 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 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Nasal |
| Prescription products | 3 in the FDA NDC Directory |
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 |
|---|---|---|
| flunisolide 0.25 mg/mL solution | Generic | $1.93 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 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.
- Bausch & Lomb Incorporated1 product
- Oceanside Pharmaceuticals1 product
- Ingenus Pharmaceuticals, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA074805Bausch · February 20, 2002
- ANDA207802Riconpharma LLC · June 16, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 30, 2022 · Class II · Completed · D-0010-2023
Out of specification for related substances (impurities).
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7 — Ingenus Pharmaceuticals Llc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1797863 |
|---|---|
| SPL set ID of the quoted label | 50d87523-e1fb-4342-825f-9dba972c6a25 |
| FDA labels (SPL) | 3 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | FLUNISOLIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Flunisolide, Oceanside Pharmaceuticals, effective May 2, 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 →