Quick answers
- What is Derma-Smoothe/Fs?
- Derma-Smoothe/Fs is a brand name of Fluocinolone acetonide, a prescription medicine. The FDA NDC Directory lists 2 Derma-Smoothe/Fs products in 1 strength and form.
- Who makes Derma-Smoothe/Fs?
- Hill Dermac holds the FDA application for Derma-Smoothe/Fs (NDA019452, approved February 3, 1988). 1 other company (repackagers or distributors) also list Derma-Smoothe/Fs products.
- Is there a generic or store brand of Derma-Smoothe/Fs?
- Yes. The FDA NDC Directory lists 16 other products with the same active ingredients, strength and form as a Derma-Smoothe/Fs product, 15 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Derma-Smoothe/Fs?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Derma-Smoothe/Fs 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 Derma-Smoothe/Fs been recalled?
- FDA enforcement reports list 2 recalls of Derma-Smoothe/Fs products; the newest started January 31, 2014. A recall usually concerns specific lots, not every product.
What Derma-Smoothe/Fs is
Each Derma-Smoothe/Fs 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) | Derma-Smoothe/Fs | 16 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
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019452 | Hill Dermac | February 3, 1988 | 2 |
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 | Brand: Derma-Smoothe/Fs | $0.2419–$0.2426 per mL 2 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 Derma-Smoothe/Fs
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Derma-Smoothe/Fs products.
- Royal Pharmaceuticals1 product
- Royal Pharmaceuticals, LLC1 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.
-
January 31, 2014 · Class III · Terminated · D-1176-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04 — Hill Dermaceuticals, Inc.
-
January 31, 2014 · Class III · Terminated · D-1177-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04 — Hill Dermaceuticals, Inc.
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.