FDA-filed SPL labeling · retrieved through openFDA

Fluocinolone

Fluocinolone acetonide is a corticosteroid used in topical, ear drop, and eye implant forms to treat inflammatory skin conditions, chronic ear eczema, diabetic macular edema, and chronic non-infectious uveitis.

Brand names SynalarCapexDermOticDerma-Smoothe FSRetisert +9 more
Drug class ⓘ Corticosteroid
Rx Forms 5 Routes Topical · Auricular (otic) · Intravitreal · Intraocular
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 33 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 18, 2024
Clinical labels in scope ⓘ33
AvailabilityRx
Earliest approval/marketing year ⓘ1963
FDA-listed product records ⓘ113
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 17, 2026 🚨Recall on record
Other forms & routes:
Topical
⭐ Fluocinolone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fluocinolone acetonide is a well-established corticosteroid available in multiple forms to treat inflammatory skin conditions, ear canal eczema, and serious eye conditions. Use the smallest amount needed for the shortest time to keep side effects low, and don't skip follow-up appointments — especially for eye implants, where pressure and vision must be monitored regularly. Always use it exactly as your doctor prescribes and reach out if symptoms worsen or new concerns appear.
How we write & review this content — our editorial policy →

📖 Fluocinolone: Patient Information Guide

A plain-language walkthrough of Fluocinolone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Fluocinolone acetonide is a corticosteroid available in several forms, each approved for specific conditions.

  • Topical oils (including Derma-Smoothe/FS Body Oil and fluocinolone acetonide topical oil) treat atopic dermatitis (eczema) in adults and moderate to severe atopic dermatitis in children 3 months of age and older (for up to 4 weeks)
  • Topical creams and ointments (including Synalar, Fluocinolone Acetonide cream and ointment) relieve inflammation and itching from a broad range of corticosteroid-responsive skin conditions
  • Topical solutions (including Synalar solution and Fluocinolone Acetonide Topical solution) relieve inflammation and itching from corticosteroid-responsive skin conditions
  • Ear drop oil formulations (Dermotic Oil, Flac Otic Oil, Fluocinolone Acetonide ear drops) treat chronic eczematous external otitis in adults and children 2 years and older
  • Iluvien (intravitreal implant) treats diabetic macular edema (DME) in patients previously treated with corticosteroids without a major rise in eye pressure, and treats chronic non-infectious uveitis affecting the posterior segment of the eye
  • Retisert (intravitreal implant) treats chronic non-infectious uveitis affecting the posterior segment of the eye
  • Yutiq (intravitreal implant) treats chronic non-infectious uveitis affecting the posterior segment of the eye
⚙️How it works▾

Fluocinolone acetonide works by blocking a key enzyme called phospholipase A2, which the body uses to kick off the inflammation process. Without this enzyme, cells can't release arachidonic acid — the raw material needed to produce prostaglandins and leukotrienes, the chemicals that cause redness, swelling, and itching. By shutting down this chain reaction, fluocinolone calms inflammation whether it's in the skin, the ear canal, or the eye.

Corticosteroids also play a broader role in regulating immune function and cellular signaling. In the skin specifically, the exact mechanism behind their benefit in atopic dermatitis is not fully understood, but the anti-inflammatory effect is well established.

💊How it's taken▾

The right way to take fluocinolone acetonide depends completely on the form your doctor prescribed — they work very differently from one another.

  • Topical oil (skin): Adults apply to affected areas 3 times daily; children 3 months and older apply twice daily after moistening the skin, for up to 4 weeks. Use the least amount needed to cover the area.
  • Topical cream or ointment (skin): Generally applied as a thin film 2 to 4 times daily, depending on the severity of your condition.
  • Ear drops: 5 drops into the affected ear twice daily for 7 to 14 days. Tilt your head and stay tilted for about one minute after applying.
  • Eye implants (Iluvien, Yutiq, Retisert): Administered by a doctor in a clinical setting — not self-applied. Follow all post-procedure monitoring appointments.
🤒Side effects — in detail▾

Side effects vary by which form of fluocinolone you're using, but here are the most commonly reported ones:

  • Skin thinning (atrophy) or stretch marks (striae) with prolonged topical use
  • Burning, itching, dryness, or irritation at the site of application
  • Acne-like breakouts (acneiform eruptions)
  • Loss of skin pigment (hypopigmentation)
  • Allergic contact dermatitis — often shows up as a failure to heal rather than a new flare
  • Cataract formation and increased eye pressure with intravitreal implants
  • Eye pain, floaters (myodesopsia), conjunctival (eye surface) bleeding, or eye irritation with eye implants

More serious reactions to watch for include signs of systemic (whole-body) steroid absorption — especially in children — and any sudden changes in vision after an eye implant, which require prompt medical attention.

⚠️Warnings & precautions▾
  • HPA axis suppression: Using too much topical corticosteroid over large skin areas or for long periods can suppress your body's natural stress hormone system. Children are at higher risk because of their larger skin-to-body-mass ratio. Signs in children include slowed growth, low cortisol levels, and in rare cases, increased pressure in the brain (bulging fontanelle, headache).
  • Local skin reactions: Skin thinning, stretch marks, and color loss can occur — some may be permanent. These risks increase with occlusive dressings, prolonged use, or more potent formulations.
  • Eye pressure and cataracts: Intravitreal implants carry a meaningful risk of raising eye pressure (which can damage the optic nerve) and causing cataracts. Regular eye monitoring is essential.
  • Eye infections: Iluvien is not for use in patients with active or suspected eye or surrounding-area infections, including herpes, fungal, or mycobacterial infections.
  • Skin infections: Corticosteroids can slow healing and mask worsening infections. If a skin infection doesn't improve, stop use and contact your doctor.
  • Peanut allergy: Some topical oil formulations contain refined peanut oil. Use with caution if you or your child is peanut-sensitive, and stop immediately if a reaction occurs.
🔀What it interacts with▾

The FDA labels for fluocinolone acetonide products do not specifically list drug-drug interactions, but there are important practical cautions to keep in mind:

  • Using more than one corticosteroid-containing product at the same time increases your total steroid exposure and raises the risk of HPA axis suppression (your body's stress hormone system being suppressed)
  • Occlusive dressings (tight wrappings or plastic films) used over topical fluocinolone significantly increase how much steroid is absorbed through the skin, which may increase systemic effects

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Tell your doctor if you have glaucoma with a large cup-to-disc ratio — Iluvien is contraindicated in this case
  • Tell your doctor about any active eye infections (herpes, fungal, bacterial) — Iluvien cannot be used during active ocular or periocular infection
  • Mention any known allergy to fluocinolone or other corticosteroids
  • Tell your doctor if you or your child is allergic to peanuts — some topical oil formulations contain refined peanut oil
  • If you are pregnant, use topical fluocinolone on the smallest area for the shortest time possible; high-potency topical steroids have been linked to low birthweight in some studies
  • If you are breastfeeding, avoid applying the topical product directly to the nipple or areola to prevent infant exposure
  • Children are at greater risk for systemic side effects and should be monitored for growth, weight, and signs of adrenal suppression during treatment
  • Tell your doctor if you have liver problems — impaired liver function can increase systemic absorption of corticosteroids
🚑If you take too much▾

Topical corticosteroids like fluocinolone acetonide can be absorbed through the skin in amounts large enough to cause whole-body (systemic) effects — even with normal use. This risk is higher if applied over large areas, under occlusive dressings, or for a long time. If you or your child shows signs of unusual fatigue, weakness, or other signs of adrenal suppression, contact your doctor promptly.

📡Pharmacodynamics — effects in the body▾

Fluocinolone acetonide topical oil falls in the low to medium range of potency compared to other topical corticosteroids, based on vasoconstrictor (blood-vessel-narrowing) studies. However, potency on a skin-blanching test does not automatically mean two products work equally well for your condition. In clinical studies, some children aged 2 to 5 years showed lower-than-normal baseline cortisol levels after 4 weeks of use, though all still responded normally to a stimulation test — meaning the adrenal glands were still functioning.

🔬Pharmacokinetics — how your body processes it▾

Fluocinolone acetonide can be absorbed through intact healthy skin, though the amount absorbed depends on the product formulation, the condition of the skin barrier, and whether an occlusive dressing is used. Inflamed or broken skin absorbs more of the drug. Once absorbed, it is processed primarily by the liver and then cleared mainly through the kidneys, with some metabolites also leaving through bile. Circulating blood levels after topical use are often too low to measure directly.

📦How to store it▾

Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

📄 Written from Fluocinolone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Fluocinolone — the kind of thing our pharmacy team would talk through with you at the counter.

What is fluocinolone acetonide actually used for? ▾
It depends on the form you have. The topical oil, cream, and ointment forms treat skin inflammation — especially eczema (atopic dermatitis) — and other itchy or inflamed skin conditions. The ear drop version treats a chronic, eczema-like inflammation of the ear canal. And there are special eye implant versions (Iluvien, Retisert, Yutiq) that doctors use to treat serious eye conditions like diabetic macular edema and chronic uveitis. Make sure you're using the exact form your doctor prescribed.
How do I apply the ear drops correctly? ▾
Tilt your head so the affected ear is pointing up, then gently pull your earlobe back and upward. Apply 5 drops and stay in that position for about a minute — this lets the oil work its way down into the ear canal. Dab any excess with a clean cotton ball. Use it twice a day for 7 to 14 days, and stop when your symptoms clear up. If things aren't improving within 2 weeks, call your doctor.
Are there areas of skin where I should NOT use fluocinolone cream or oil? ▾
Yes — don't apply it to your face, armpits, or groin unless your doctor specifically tells you to. Also avoid the diaper area in babies. These are sensitive spots where steroid absorption is higher and the risk of side effects like skin thinning is greater. Only apply it to the areas your doctor has directed.
My child is using this. Are there any extra concerns I should know about? ▾
Children's bodies absorb more steroid through the skin relative to their size than adults do, so they're more sensitive to side effects. With prolonged use, there's a risk of the medication suppressing the body's natural steroid production — signs can include slowed growth, unusual tiredness, or weight changes. For kids 3 months and older using the topical oil, the recommended course is twice daily for no more than 4 weeks. Keep your child's follow-up appointments so their doctor can check for any concerns.
I'm pregnant — is it safe to use the topical form? ▾
There's no confirmed link between topical fluocinolone and major birth defects in humans, but high-potency topical steroids used heavily during pregnancy have been associated with low birth weight in some studies. The guidance is to use it on the smallest area of skin possible and for the shortest time you need it. Talk to your doctor about whether the benefit outweighs any risk in your specific situation, and don't stop a prescribed medication without checking first.
What side effects should make me call my doctor right away? ▾
For topical forms: contact your doctor if your skin condition suddenly gets worse instead of better (which can signal an allergic reaction to the product), if you notice a skin infection that isn't clearing, or if you see unusual skin thinning or color loss. For eye implants: get in touch with your eye doctor right away if you experience sudden changes in vision, increasing eye pain, unusual redness, or new floaters — these could signal rising eye pressure or an infection, both of which need prompt attention.
Is Fluocinolone available over the counter? ▾
Fluocinolone is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Fluocinolone first available? ▾
Fluocinolone has been available in the United States since at least 1963, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fluocinolone? ▾
Fluocinolone is supplied by 37 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Medimetriks Pharmaceuticals, Inc., Padagis Israel Pharmaceuticals Ltd.

💬 Answers drafted from Fluocinolone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerFluocinolone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fluocinolone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Fluocinolone comes

Fluocinolone is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Derma-Smoothe/FS Fluocinolone Acetonide Synalar
How this form is used
What it may be used for
  • Fluocinolone Acetonide cream and ointment relieve inflammation and itching from corticosteroid-responsive skin conditions
  • Synalar Cream and Synalar Ointment are used for inflammatory and itchy skin conditions that respond to corticosteroids
Important instructions
  • Apply a thin film to the affected area 2 to 4 times daily depending on how severe the condition is
  • In hairy areas, part the hair to allow the product to make direct contact with the skin
  • Do not apply to the face, armpits, or groin unless your doctor tells you to
  • If using an occlusive (sealing) dressing, stop using it if a skin infection develops and contact your doctor
Available strengths 5 strengths
0.01 mg/100 mL 0.1 mg/g 0.11 mg/118.28 mL 0.11 mg/mL 0.25 mg/g
64 FDA-listed product records ⓘ

Ear drops

In the ear
Brands Dermotic Flac Otic Oil Fluocinolone Acetonide
How this form is used
What it may be used for
  • Dermotic Oil is used for chronic eczematous external otitis in adults and children 2 years and older
  • Flac Otic Oil is used for chronic eczematous external otitis in adults and children 2 years and older
  • Fluocinolone Acetonide ear drops are used for chronic eczematous external otitis in adults and children 2 years and older
Important instructions
  • Tilt your head so the affected ear faces up, gently pull the ear lobe back and upward, and apply 5 drops into the ear canal
  • Keep your head tilted for about one minute so the drops can reach down into the ear canal
  • Use twice daily for 7 to 14 days; stop when the condition clears or call your doctor if there's no improvement within 2 weeks
  • Do not use in the eyes, by mouth, or in the vaginal area — these drops are for the ear only
Available strengths 2 strengths
0.11 mg/20 mL 0.11 mg/mL
17 FDA-listed product records ⓘ

Topical solution

On the skin
Brands Fluocinolone Acetonide Fluocinolone Acetonide Topical Synalar
How this form is used
What it may be used for
  • Fluocinolone Acetonide Topical Solution relieves inflammation and itching from corticosteroid-responsive skin conditions
  • Fluocinolone Acetonide Topical solution is indicated for inflammatory and pruritic (itchy) dermatoses that respond to corticosteroids
Important instructions
  • Apply to affected skin areas as directed by your doctor; follow the frequency on your prescription label
  • Do not apply to the face, armpits, or groin unless directed by your prescriber
  • Use the least amount needed to cover the affected area
  • Stop use when the condition is controlled and contact your doctor if there is no improvement within 2 weeks
Available strengths 1 strength
0.1 mg/mL
10 FDA-listed product records ⓘ

Eye drops

In the eye
Brands Iluvien Retisert Yutiq
How this form is used
What it may be used for
  • Iluvien is used to treat diabetic macular edema (DME) in patients who have already been treated with corticosteroids without a significant rise in eye pressure
  • Iluvien is also used for chronic non-infectious uveitis affecting the posterior segment of the eye
  • Retisert is used for chronic non-infectious uveitis affecting the posterior segment of the eye
  • Yutiq is used for chronic non-infectious uveitis affecting the posterior segment of the eye
Important instructions
  • Iluvien and Yutiq are given by intravitreal injection (into the eye) by a doctor under sterile conditions — patients do not self-administer
  • Retisert is surgically implanted into the back of the eye through a small incision by an eye surgeon
  • After receiving Iluvien or Yutiq, you will be monitored for rising eye pressure and signs of eye infection
  • Report any new eye pain, redness, increased floaters, or vision changes to your doctor right away after any implant procedure
Available strengths 3 strengths
0.18 mg 0.19 mg 0.59 mg
9 FDA-listed product records ⓘ

Insert or device

By mouth
Available strengths 1 strength
0.59 mg/0.59 mg
1 FDA-listed product record ⓘ

📊 Fluocinolone across the U.S. market

How Fluocinolone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5
Dose forms ⓘ
37
Manufacturers
12
Brand names
113
FDA-listed product records ⓘ
1963
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (8) · Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack12%
Medimetriks Pharmaceuticals, Inc.8%
Padagis Israel Pharmaceuticals Ltd7%
Amneal Pharmaceuticals LLC6%
ANI Pharmaceuticals, Inc.5%
Royal Pharmaceuticals5%
Other makers56%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Fluocinolone is used

A general measure of how commonly Fluocinolone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Fluocinolone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

320,047
Medicaid prescriptions filled (Q1–Q4 2025)
$10.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fluocinolone prescribed? Of the 1,596 medications we measure, Fluocinolone ranks #317 by Medicaid prescriptions — more than 80% of them.

Where Fluocinolone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #317 of 1,596
#312 Ubrogepant 329,850 Rx #313 Midodrine 328,426 Rx #314 Dexamethasone / Neomyc... 327,807 Rx #315 Prochlorperazine 323,439 Rx #316 Lansoprazole 322,236 Rx #317 Fluocinolone 320,047 Rx #318 Bevacizumab Injection 309,873 Rx #319 Temazepam 303,646 Rx #320 Nitroglycerin Sublingu... 303,475 Rx #321 Methoxy Polyethylene G... 301,411 Rx #322 Torsemide 301,185 Rx

Utilization by Fluocinolone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.1 mg/mL topical oil is the most-dispensed Fluocinolone product — about 77% of these Medicaid prescriptions.

fluocinolone acetonide 0.1 MG/ML Topical Oil Most dispensed

247,898 Medicaid prescriptions (Q1–Q4 2025) 77% of Fluocinolone prescriptions shown $8.4M gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 10 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191307

fluocinolone acetonide 0.1 MG/ML Otic Solution

36,025 Medicaid prescriptions (Q1–Q4 2025) 11% of Fluocinolone prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191299

fluocinolone acetonide 0.1 MG/ML Topical Solution

22,788 Medicaid prescriptions (Q1–Q4 2025) 7% of Fluocinolone prescriptions shown $544,726 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191310

fluocinolone acetonide 0.00025 MG/MG Topical Ointment

5,928 Medicaid prescriptions (Q1–Q4 2025) 2% of Fluocinolone prescriptions shown $290,196 gross reimbursement (before rebates) ≈ $49 per prescription (gross)

Summed across the 6 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191256

fluocinolone acetonide 0.1 MG/ML Topical Cream

3,975 Medicaid prescriptions (Q1–Q4 2025) 1% of Fluocinolone prescriptions shown $292,681 gross reimbursement (before rebates) ≈ $74 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191302

fluocinolone acetonide 0.25 MG/ML Topical Cream

3,433 Medicaid prescriptions (Q1–Q4 2025) 1% of Fluocinolone prescriptions shown $253,879 gross reimbursement (before rebates) ≈ $74 per prescription (gross)

Summed across the 4 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191315

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluocinolone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 31 of 85 listed Fluocinolone NDCs with Medicaid activity.

🔍 Compare Fluocinolone products

A representative set of FDA-listed product records for Fluocinolone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 113 of 113 products — FDA National Drug Code Directory. See every product, package size and price: browse all 113 Fluocinolone NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fluocinolone RxCUI 25126 8 dose forms · 14 strengths
  2. Dose form (SCDF) Medicated Shampoo RxCUI 377518 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.1 MG/ML RxCUI 1191265
  3. Dose form (SCDF) Otic Solution RxCUI 603749 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.1 MG/ML RxCUI 1191299
  4. Dose form (SCDF) Topical Cream RxCUI 377894 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.025 MG/ML RxCUI 1191346 acetonide 0.0625 MG/ML RxCUI 1191348 acetonide 0.1 MG/ML RxCUI 1191302 acetonide 0.25 MG/ML RxCUI 1191315
  5. Dose form (SCDF) Topical Gel RxCUI 377993 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.00025 MG/MG RxCUI 1191344
  6. Dose form (SCDF) Topical Oil RxCUI 385106 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.1 MG/ML RxCUI 1191307
  7. Dose form (SCDF) Topical Ointment RxCUI 372221 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.0000625 MG/MG RxCUI 1191339 acetonide 0.00025 MG/MG RxCUI 1191256
  8. Dose form (SCDF) Topical Solution RxCUI 374426 In current FDA listings
    Clinical drug / strength (SCD) acetonide 0.1 MG/ML RxCUI 1191310

Look up RxCUI 25126 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Synalar Capex DermOtic Derma-Smoothe FS Retisert Iluvien Flac Yutiq Fluocinolone Acetonide Derma-Smoothe/FS Fluocinolone Acetonide Oil Flac Otic Oil Fluocinolone Acetonide Topical Synalar TS

🏭 Manufacturers & labelers

Bryant Ranch Prepack 14 Medimetriks Pharmaceuticals, Inc. 9 Padagis Israel Pharmaceuticals Ltd 8 Amneal Pharmaceuticals LLC 7 ANI Pharmaceuticals, Inc. 6 Royal Pharmaceuticals 6 Quagen Pharmaceuticals LLC 6 Glenmark Pharmaceuticals Inc., USA 6 Rising Pharmaceuticals, Inc. 5 Cosette Pharmaceuticals, Inc. 5 Taro Pharmaceuticals U.S.A., Inc. 3 A-S Medication Solutions 3 Sun Pharmaceutical Industries, Inc. 3 Rising Pharma Holdings, Inc. 3 Alimera Sciences, Inc. 3 Glasshouse Pharmaceuticals Limited Canada 2 EyePoint Pharmaceuticals, Inc 2 Bausch & Lomb Incorporated 2 Patrin Pharma, Inc. 2 Actavis Pharma, Inc. 1 Fougera Pharmaceuticals Inc. 1 Spectrum Laboratory Products, Inc. 1 Sicor S.r.l. 1 Sicor S.p.a. 1

…and 13 more on the FDA NDC directory.

RxNorm drug class

Fluocinolone belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, Corticosteroids, potent (group III), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 18, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fluocinolone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fluocinolone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
33
NDC products indexed
113
Distinct labelers/manufacturers represented
37
Linked representative label ⓘ
Medimetriks Pharmaceuticals, Inc.
Linked label effective
Jul 18, 2024
Composite sections available
21
Linked SPL Set ID
5af2e4c1-082b-48a0-aae7-72d4a68cbb2d
Linked SPL Document ID
890554e0-30dd-4f2c-a469-f8822ca89cab
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 33 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Medimetriks Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.