Prescription medicine
Fluocinolone Brand names: Synalar, Derma-Smoothe, Yutiq, Dermotic, Iluvien
Fluocinolone (Synalar) is a prescription medicine with an FDA approval on record since 1963. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.171 per mL (Fluocinolone 0.01% scalp oil) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fluocinolone FDA label on DailyMed (effective February 26, 2023, Quagen Pharmaceuticals LLC); the NDA 12787 record on Drugs@FDA; every fluocinolone label on DailyMed.
Highlights of the record
FDA label of February 26, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (scalp oil).
Forms and strengths
- 0.18 mg
- 0.19 mg
- 0.01 mg/100ml
- 0.1 mg/ml
- 0.1 mg/g
- 0.11 mg/ml
- 0.11 mg/118.28ml
- 0.25 mg/g
Oil; solution; cream; ointment; implant.
On the market
- Earliest approval on file
- February 15, 1963 Synalar, Eurofarma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 50 first April 27, 1982; 26 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 15 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- November 7, 2028 Iluvien injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.171 per mL Fluocinolone 0.01% scalp oil
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 14 since 2013 0 Class I among all firms' recalls; latest December 30, 2025
- FAERS reports
- 3,748 through July 30, 2026
What is fluocinolone used for?
From the label: indications and usageFluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (scalp oil).
Conditions named in the indications of fluocinolone's FDA labels, with every medicine labeled for each:
From other fluocinolone labelsEczema (atopic dermatitis): Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Fluocinolone Acetonide), Quagen Pharmaceuticals LLC, effective February 26, 2023 (SPL set fa5eba5b-57bf-4d46-b0e1-c7104542cb46), via openFDA; the full label on DailyMed
Is there a generic for fluocinolone (Synalar)?
The FDA approved the first generic fluocinolone on April 27, 1982. 50 generic applications are approved; 26 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluocinolone from 15 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Synalar cream; a patent listed only for Iluvien injection runs to November 7, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1963 earliest approval on file
- 1982 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluocinolone (Synalar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.171 per mL (Fluocinolone 0.01% scalp oil), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluocinolone 0.01% scalp oil (generic)
- Derma-smoothe-fs scalp oil (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluocinolone 0.01% body oil | Generic | $0.175 per mL | n/a | +2% |
| Fluocinolone 0.01% cream | Generic | $1.45 per gram | n/a | -7% |
| Fluocinolone 0.01% scalp oil | Generic | $0.171 per mL | n/a | -0.9% |
| Fluocinolone 0.01% solution | Generic | $0.200 per mL | n/a | -3% |
| Fluocinolone 0.025% cream | Generic | $1.20 per gram | n/a | -10% |
| Fluocinolone 0.025% ointment | Generic | $0.915 per gram | n/a | no change |
| Fluocinolone oil 0.01% ear drp | Generic | $0.924 per mL | n/a | -5% |
| Derma-smoothe-fs body oil | Brand | $0.243 per mL | n/a | -18% |
| Derma-smoothe-fs scalp oil | Brand | $0.242 per mL | n/a | -14% |
| Dermotic oil 0.01% ear drops | Brand | $1.13 per mL | n/a | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fluocinolone been recalled?
The FDA's Enforcement Report lists 14 recalls naming fluocinolone since 2013: 0 Class I (the most serious), 8 Class II, 6 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 30, 2025 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. |
| January 4, 2024 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol |
| May 21, 2021 | Class II | Hill Dermaceuticals, Inc. | Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. |
| January 15, 2019 | Class II | LUPIN SOMERSET | Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been … |
| October 5, 2018 | Class II | LUPIN SOMERSET | Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis |
| July 5, 2018 | Class II | Teva Pharmaceuticals USA | Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for … |
| April 13, 2018 | Class II | Lyne Laboratories, Inc. | Subpotent Drug |
| February 22, 2017 | Class III | Novel Laboratories, Inc. | Chemical Contamination |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for fluocinolone?
The FDA Adverse Event Reporting System holds 3,748 reports that list fluocinolone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 69 are coded as a death and 429 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fluocinolone?
15 other medicines are given the same way (topical) and in the same FDA class as fluocinolone or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Hydrocortisone | Eczema (atopic dermatitis) | 30 labelers | $0.0613 per gram 1% cream | A presentation being discontinued |
| Clobetasol | Psoriasis | 40 labelers | $0.126 per gram 0.05% ointment | No current entry |
| Betamethasone | Psoriasis | 26 labelers | $0.418 per gram 0.05% cream | No current entry |
| Desoximetasone | Psoriasis | 13 labelers | $0.369 per gram 0.25% ointment | No current entry |
| Desonide | Eczema (atopic dermatitis) | 12 labelers | $0.252 per gram 0.05% cream | No current entry |
| Fluticasone | Eczema (atopic dermatitis) | 8 labelers | $0.243 per gram 0.05% cream | No current entry |
| Halobetasol | Psoriasis | 6 labelers | $0.620 per gram 0.05% ointmnt | No current entry |
| Betamethasone and calcipotriene | Psoriasis | 5 labelers | $1.81 per gram 0.005%-0.064% ointment | No current entry |
Every medicine labeled for the same conditions as fluocinolone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fluocinolone compare with medicines for the same use?
4 side-by-side pages set fluocinolone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fluocinolone
- 15 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluocinolone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other