Prescription medication · Topical Corticosteroid
fluocinolone
Also sold as Synalar, Derma-Smoothe. This medicine treats skin problems that cause swelling and itching.
Data updated 2026-05-15
- 1
- Recall record
fluocinolone (Synalar) is a prescription Topical Corticosteroid. This medicine treats skin problems that cause swelling and itching.
Fluocinolone is a topical steroid medicine. It helps reduce swelling, itching, and redness of the skin.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.16/unit
Generic Available
Yes (23 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: FLUOCINOLONE 0.01% BODY OIL
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +5.4% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| April 17, 2024 | $0.1709/ML | - | 1 |
| July 17, 2024 | $0.1513/ML | -11.4% | 1 |
| December 18, 2024 | $0.1595/ML | +5.4% | 4 |
What it does
This medicine treats skin problems that cause swelling and itching.
Common side effects
Burning, Itching, Irritation
Key warnings
If you get an infection, stop using bandages and talk to your doctor about treatment.
The sections below are summarized in plain English from fluocinolone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Fluocinolone is a corticosteroid. It works by reducing inflammation. This helps to relieve itching and other skin problems.
Serious Warnings
If you get an infection, stop using bandages and talk to your doctor about treatment.
Common Questions
What is fluocinolone used for?
How often should I apply it?
Can I use a bandage with this medicine?
What should I do if I get an infection?
Can I use this medicine if I am pregnant?
How should I store this medicine?
What should I do if I miss a dose?
Can this medicine cause side effects?
Who should not use this medicine?
What does this medicine contain?
What are the common side effects of fluocinolone?
What drug class is fluocinolone?
What pregnancy or breastfeeding source fields are listed for fluocinolone?
Has fluocinolone been recalled?
Active Recalls
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC
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What the FDA Data Shows for fluocinolone
The FDA label for fluocinolone (sold under brand names such as Synalar, Derma-Smoothe) classifies it as a prescription-only medication in the Topical Corticosteroid class. This medicine treats skin problems that cause swelling and itching. Official labeling lists 4 commonly reported side effects, including Burning, Itching, Irritation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.16.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: July 3, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages