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Brand-name prescription medicine

Flac Otic Oil

Generic name: Fluocinolone acetonide

FDA application holder: Anda Repository

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

1Strengths and forms
17Same medicine, other names
2018FDA approval
0Recalls (FDA reports)

Quick answers

What is Flac Otic Oil?
Flac Otic Oil is a brand name of Fluocinolone acetonide, a prescription medicine. The FDA NDC Directory lists 1 Flac Otic Oil product in 1 strength and form.
Who makes Flac Otic Oil?
Anda Repository holds the FDA application for Flac Otic Oil (ANDA210736, approved April 11, 2018).
Is there a generic or store brand of Flac Otic Oil?
Yes. The FDA NDC Directory lists 17 other products with the same active ingredients, strength and form as a Flac Otic Oil product, 14 of them generic. Ask your pharmacist whether one is right for you.
Has Flac Otic Oil been recalled?
No recall linked to Flac Otic Oil products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Flac Otic Oil is

Each Flac Otic 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 formProduct namesSame medicine, other namesLabel
fluocinolone acetonide 0.11 mg/mL
oil (auricular (otic))		 Flac Otic Oil 17 products, 7 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.
FDA applications of Flac Otic Oil products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
ANDA210736Anda RepositoryApril 11, 20181

Companies that list Flac Otic Oil

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Flac Otic Oil products.

Recalls

No recall linked to Flac Otic Oil products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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