Quick answers
- What is Fluocinolone Acetonide Oil?
- Fluocinolone Acetonide Oil is a brand name of Fluocinolone acetonide, a prescription medicine. The FDA NDC Directory lists 4 Fluocinolone Acetonide Oil products in 2 strengths and forms.
- Who makes Fluocinolone Acetonide Oil?
- Rising holds the FDA application for Fluocinolone Acetonide Oil (ANDA090982, approved April 25, 2016). 1 other company (repackagers or distributors) also list Fluocinolone Acetonide Oil products.
- Is there a generic or store brand of Fluocinolone Acetonide Oil?
- Yes. The FDA NDC Directory lists 28 other products with the same active ingredients, strength and form as a Fluocinolone Acetonide Oil product, 22 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Fluocinolone Acetonide Oil?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Fluocinolone Acetonide Oil strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Fluocinolone Acetonide Oil been recalled?
- FDA enforcement reports list 3 recalls of Fluocinolone Acetonide Oil products; the newest started April 13, 2018. A recall usually concerns specific lots, not every product.
What Fluocinolone Acetonide Oil is
Each Fluocinolone Acetonide Oil product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Fluocinolone acetonide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| fluocinolone acetonide 0.11 mg/mL oil (topical) | Fluocinolone Acetonide Oil | 14 products, 6 companies | DailyMed |
| fluocinolone acetonide 0.11 mg/mL oil (auricular (otic)) | Fluocinolone Acetonide Oil | 14 products, 6 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Fluocinolone acetonide →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA090982 | Rising | April 25, 2016 | 2 |
| ANDA203377 | Rising | April 25, 2016 | 1 |
| ANDA203378 | Rising | April 25, 2016 | 1 |
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 |
|---|---|---|
| fluocinolone acetonide 0.11 mg/mL oil | Generic: Fluocinolone Acetonide Oil | $0.1663–$0.9066 per mL 3 packages, lowest to highest Generic of the same strength and form: $0.1663–$0.9066 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 Fluocinolone Acetonide Oil
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Fluocinolone Acetonide Oil products.
- Rising Pharma Holdings, Inc.3 products
- A-S Medication Solutions1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2018 · Class II · Terminated · D-0712-2018
Subpotent Drug
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC — Lyne Laboratories, Inc.
-
April 13, 2018 · Class II · Terminated · D-0711-2018
Subpotent Drug
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 6498 — Lyne Laboratories, Inc.
-
April 13, 2018 · Class II · Terminated · D-0713-2018
Subpotent Drug
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 6498 — Lyne Laboratories, Inc.
Next steps
- Fluocinolone acetonideThe medicine itself: side effects, interactions, dosage and generics
- Find a pharmacy near youAsk which price applies to you
- Latest FDA drug recallsNewest first
- All brand-name medicinesSearch by brand or product name
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.