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Fluocinolone

Fluocinolone (fluocinolone acetonide) is a corticosteroid used on the skin for atopic dermatitis and other inflammatory, itchy skin conditions, in the ear for chronic eczematous external otitis, and as an eye implant for diabetic macular edema and chronic non-infectious uveitis.

Brand names SynalarCapexDermOticDerma-Smoothe FSRetisert +8 more
Drug class Corticosteroid
Rx Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 →

✓No current FDA shortage listed · checked Oct 7, 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.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Fluocinolone is a moderate-strength corticosteroid that calms inflammation and itch, used mostly on the skin for eczema and similar rashes, and also as an ear oil and long-acting eye implants. It is a familiar standby, on the market since the 1960s and available generically. Used sparingly, the skin forms are well tolerated, and most people notice little beyond mild burning, dryness or irritation where it goes on. The thing to watch is overuse, because heavy or prolonged use, especially under bandages, can thin the skin (sometimes permanently) and let enough steroid absorb to suppress the body’s own adrenal hormones, which matters most in children.

Clinical pearls

  • The body oil and ear oil contain refined peanut oil, so mention any peanut allergy before using them.
  • Keep the oil off the face, armpits and groin, and never use it in a child’s diaper area.
  • Stop once the rash is under control, and call your prescriber if it is not clearly better within 2 weeks.
  • Report any vision change promptly, since steroids, especially the eye implants, can raise eye pressure and cause cataracts.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTopical cream, ointment or gel, Ear drops, Eye drops +2
Earliest FDA record1963
Companies listing it with the FDA19
FDA label last updatedJul 18, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Fluocinolone, written from its FDA label.

What Fluocinolone is used for

▾

Fluocinolone is a corticosteroid with several uses depending on the product.

  • Fluocinolone creams, ointments and topical solutions (including Synalar): relieve inflammation and itching from corticosteroid-responsive dermatoses.
  • Fluocinolone topical oil and Derma-Smoothe/FS Body Oil: atopic dermatitis in adults, and moderate to severe atopic dermatitis in children 3 months and older for up to 4 weeks.
  • Ear oils (Dermotic, Flac Otic Oil, fluocinolone acetonide oil): chronic eczematous external otitis in adults and children 2 years and older.
  • Iluvien implant: diabetic macular edema in people previously treated with steroids without a significant rise in eye pressure, and chronic non-infectious uveitis of the back of the eye.
  • Yutiq and Retisert implants: chronic non-infectious uveitis affecting the back of the eye.

How Fluocinolone works

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Corticosteroids reduce inflammation. They limit swelling, blood vessel widening, white blood cell movement and scar formation. They are thought to block phospholipase A2, which reduces the body's production of inflammatory chemicals like prostaglandins and leukotrienes.

Fluocinolone dosage

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Dosing differs by product, so follow your prescriber and label.

  • Creams and ointments: generally a thin film two to four times daily. Hair should be parted at hairy sites.
  • Topical oil: adults apply three times daily; children moisten the skin first and apply twice daily for up to 4 weeks.
  • Ear oil: 5 drops in the affected ear twice daily for 7 to 14 days.
  • Eye implants: placed by an eye specialist, by injection (Iluvien, Yutiq) or surgery (Retisert).

Stop the oils once the condition is controlled, and contact your provider if there is no improvement in 2 weeks.

Dosing details from the FDA-approved label

From the Fluocinolone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Iluvien intravitreal implant: ophthalmic intravitreal injection
    • For ophthalmic intravitreal injection under aseptic conditions
    • Implant placed inferior to the optic disc and posterior to the equator of the eye, 4 millimeters inferotemporal from the limbus
  • Yutiq intravitreal implant: ophthalmic intravitreal injection
    • For ophthalmic intravitreal injection under aseptic conditions
    • Implant placed inferior to the optic disc and posterior to the equator of the eye, 4 millimeters inferotemporal from the limbus
  • Retisert intravitreal implant
    • Surgically implanted into the posterior segment of the affected eye through a pars plana incision
    • One tablet of 0.59 mg of fluocinolone acetonide
    • Designed to release at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3-0.4 mcg/day over approximately 30 months
    • May be replaced following depletion of fluocinolone acetonide as evidenced by recurrence of uveitis
  • Fluocinolone acetonide topical oil: adult patients
    • Apply as a thin film to the affected areas three times daily
    • Discontinue use when control of disease is achieved within 2 weeks or contact the healthcare provider if no improvement is seen within 2 weeks
  • Fluocinolone acetonide topical oil: pediatric patients
    • Moisten skin and apply to affected areas twice daily for up to 4 weeks
    • Do not apply to the diaper area
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Fluocinolone acetonide topical oil is not for oral, ophthalmic, or intravaginal use. ( 2.1 ) • Do not use on face or intertriginous areas. ( 2.1 ) • Adult patients: Apply to affected areas 3 times daily. ( 2.2 ) • Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.3 ) 2.1 Important Administration Instructions Fluocinolone acetonide topical oil is for topical use only. Not for oral, ophthalmic, or intravaginal use. Apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas. Discontinue use when control of disease is achieved within 2 weeks or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use on the face, axillae, or groin unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions ( 6 ) and Use in Specific Populations ( 8.4 )] . Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use [see Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage in Adults Apply fluocinolone acetonide topical oil as a thin film to the affected areas three times daily . 2.3 Recommended Dosage in Pediatric Patients Moisten skin and apply fluocinolone acetonide topical oil as a thin film to the affected areas twice daily for up to four weeks .

Read the full Dosage and Administration section on DailyMed →

Fluocinolone side effects

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Side effects vary by form. Skin and ear products can cause local reactions.

Common side effects

  • Skin thinning (atrophy) and stretch marks (striae)
  • Burning, itching, irritation or dryness
  • Acne-like breakouts or inflamed hair follicles
  • Lighter skin patches (hypopigmentation)
  • Allergic skin reaction (allergic contact dermatitis)
  • Eye implants: cataract and raised eye pressure
  • Eye implants: eye pain, floaters, bleeding on the eye surface
  • Acne-like breakouts, folliculitis

When to get medical help

  • Call your doctor if your skin condition does not improve within 2 weeks, or if it gets worse.
  • Report any vision changes, since steroids can raise the risk of glaucoma and cataract.
  • Call your doctor if you notice signs of too much steroid absorbed into the body, such as slowed growth or delayed weight gain in a child.
  • Tell your doctor if a skin infection develops or worsens, as steroids can delay healing.
  • Stop the topical oil and get help for signs of an allergic reaction, such as hives or itching, especially if you are sensitive to peanuts.
  • After an eye implant, get help for eye pain, vision loss or signs of infection, as pressure and infection (endophthalmitis) need monitoring.

Call your doctor for vision changes, signs of infection, signs of steroid effects throughout the body, or worsening of your condition.

Fluocinolone warnings and precautions

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The main risk of topical steroids is absorption into the body, causing adrenal suppression, Cushing's syndrome and high blood sugar. Children are at higher risk. Large areas, long use, bandage coverings, damaged skin, liver failure and young age increase absorption.

  • Local reactions such as skin thinning may sometimes be irreversible.
  • Steroids can raise the risk of glaucoma and cataract. Keep topical oil away from eyes.
  • Steroids can delay healing or worsen skin infections.
  • Topical oil contains refined peanut oil.
  • Plastic bandage films may be flammable and can pose a suffocation risk for children.

Fluocinolone interactions

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The label gives limited interaction information.

  • Using more than one steroid-containing product at once can increase total steroid exposure.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Fluocinolone against a supplement or herb →

Before taking Fluocinolone

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  • Iluvien must not be used with active or suspected eye infections, glaucoma with a high cup-to-disc ratio, or known allergy to its components.
  • Be cautious with peanut sensitivity when using the topical oil.
  • Children are more susceptible to whole-body effects.
  • Topical oils: not established under 3 months. Ear oils: ages 2 and older.
  • Pregnancy: use the smallest area for the shortest time.
  • Breastfeeding: use the smallest area for the shortest time and avoid the nipple and areola.
  • Liver failure can increase absorption.

Fluocinolone overdose

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Topical steroids can be absorbed enough to cause effects throughout the body, even with normal use. Contact your doctor or poison control if you suspect you've used too much.

What Fluocinolone does in the body

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Fluocinolone topical oil is low to medium in strength compared with other topical steroids. In children treated twice daily for 4 weeks, some aged 2 to 5 had low morning cortisol, but all responded normally to testing.

How your body processes Fluocinolone

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Topical steroids can be absorbed through healthy skin. Absorption is higher with inflamed skin, bandage coverings and certain formulations. Once absorbed, they are broken down mainly in the liver and cleared by the kidneys, and some leave through bile.

How to store Fluocinolone

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

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Fluocinolone: pharmacist answers to common questions

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 this medicine for?

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It depends on the product. Creams, ointments and solutions calm itchy, inflamed skin. The oils treat atopic dermatitis or, for ear oil, chronic eczematous external otitis. Eye implants treat uveitis or diabetic macular edema.

How should I use the skin product?

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Use the smallest amount that covers the area. Creams and ointments are usually a thin film a few times a day, and the oils follow their own schedule. If there's no improvement in 2 weeks with the oils, call your provider.

How do I use the ear oil?

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Tilt your head, gently pull your ear lobe back and up, and use the dropper to put in 5 drops. Stay tilted for about a minute, then pat away extra oil with a cotton ball. It's usually twice daily for 7 to 14 days.

Can I use it on my face or in skin folds?

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Not the oil, unless your provider tells you to. Skin folds, armpits and groin carry a higher risk of side effects. Keep it out of your eyes, mouth and vagina.

What side effects should I watch for?

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Skin thinning, stretch marks, burning, dryness, acne-like bumps and lighter skin can happen. Tell your doctor about vision changes, infection, or a child who isn't growing or gaining weight normally.

Is it safe in pregnancy or for children?

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If you're pregnant or breastfeeding, use the smallest area for the shortest time and keep it off the nipple. Children absorb more through the skin, so they need closer monitoring and use only within the ages the label supports.

Is Fluocinolone available over the counter?

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No. Fluocinolone is a prescription medicine: every Fluocinolone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Fluocinolone first available?

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The earliest FDA record we hold for Fluocinolone is from 1963: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Fluocinolone was first used.

Who makes Fluocinolone?

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19 companies currently list Fluocinolone products in the FDA's NDC Directory, including Bryant Ranch Prepack, ANI Pharmaceuticals, Inc., Cosette Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Fluocinolone on HelloPharmacist

🌿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
Detailed data & references for Fluocinolone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Fluocinolone forms and strengths (how it 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fluocinolone inactive ingredients by manufacturer.

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
  • Synalar cream and ointment relieve inflammation and itching from corticosteroid-responsive dermatoses.
  • Derma-Smoothe/FS Body Oil treats atopic dermatitis in adults and moderate to severe atopic dermatitis in children 3 months and older.
Important instructions
  • Fluocinolone acetonide cream and ointment are generally applied as a thin film two to four times daily.
  • Derma-Smoothe/FS: adults apply three times daily; children moisten skin and apply twice daily for up to 4 weeks.
  • Derma-Smoothe/FS is not for the face, skin folds, eyes, mouth or vagina unless directed by your provider.
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
60 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, Flac Otic Oil and fluocinolone acetonide ear oil treat chronic eczematous external otitis in adults and children 2 years and older.
Important instructions
  • Fluocinolone acetonide ear oil: tilt head, pull the ear lobe back and up, and use the supplied dropper to apply 5 drops.
  • Dermotic: stay tilted about a minute, then pat away excess with a clean cotton ball.
  • Dermotic: used twice daily for 7 to 14 days, stopping when controlled within 2 weeks.
  • Dermotic is for the ear only, not for the mouth, eyes or vagina.
Available strengths 1 strength
0.11 mg/mL
15 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 treats diabetic macular edema in people previously treated with steroids without a significant rise in eye pressure.
  • Iluvien treats chronic non-infectious uveitis affecting the back of the eye.
  • Yutiq treats chronic non-infectious uveitis affecting the back of the eye.
  • Retisert treats chronic non-infectious uveitis affecting the back of the eye.
Important instructions
  • Iluvien and Yutiq are given by an eye doctor as an injection into the eye under sterile conditions.
  • Retisert is surgically implanted into the back of the eye.
  • After Iluvien or Yutiq injection, eye pressure and infection are monitored.
Available strengths 3 strengths
0.18 mg 0.19 mg 0.59 mg
7 FDA-listed product records ⓘ

Topical solution

On the skin
Brands Fluocinolone Acetonide Fluocinolone Acetonide Topical
How this form is used
What it may be used for
  • Fluocinolone acetonide topical solution relieves inflammation and itching from corticosteroid-responsive dermatoses.
Available strengths 1 strength
0.1 mg/mL
6 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 on the U.S. market: products, makers and brands

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.

19 companies list 46 Fluocinolone product records with the FDA, mostly as topical cream, ointment or gel, ear drops, eye drops; the earliest marketing or approval year on record is 1963. Brand names on the directory include Synalar, Capex, DermOtic and 10 more; the rest are generics.

5
Dose forms ⓘ
19
Labelers (makers, repackagers, distributors)
10
Brand names
46
FDA-listed product records ⓘ
1963
Earliest FDA record ⓘ

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) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack22%
ANI Pharmaceuticals, Inc.11%
Cosette Pharmaceuticals, Inc.7%
Padagis Israel Pharmaceuticals Ltd7%
Quagen Pharmaceuticals LLC7%
Rising Pharma Holdings, Inc.7%
Other makers41%

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 (Medicaid data)

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 1,601 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 1,601
#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 46 of 46 products — FDA National Drug Code Directory. See every product, package size and price: browse all 46 Fluocinolone NDCs →

Fluocinolone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Fluocinolone recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Dec 30, 2025 · SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
  • Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4 Lots: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027 FDA record D-0256-2026 →
Class II Jan 4, 2024 · Terminated · Glenmark Pharmaceuticals Inc., USA
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
  • Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District… Lots: Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024 FDA record D-0259-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

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.

💵 What Fluocinolone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Oil · Topical 0.01 mg/100 mL $0.171 per mL NDC details & price history
Oil · Topical 0.11 mg/118.28 mL $0.175 per mL NDC details & price history
Oil · Auricular (otic) 0.11 mg/mL $1.32 per mL NDC details & price history
Ointment · Topical 0.25 mg/g $0.571–$1.26 per gram NDC details & price history
Cream · Topical 0.25 mg/g $1.01–$1.39 per gram NDC details & price history
Cream · Topical 0.1 mg/g $1.20–$1.71 per gram NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Fluocinolone brand names

Fluocinolone is sold under 13 brand names in the FDA directory — Synalar, Capex, DermOtic, Derma-Smoothe FS and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

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

Who makes Fluocinolone: manufacturers and labelers

19 companies list Fluocinolone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, ANI Pharmaceuticals, Inc., Cosette Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 10 ANI Pharmaceuticals, Inc. 5 Cosette Pharmaceuticals, Inc. 3 Padagis Israel Pharmaceuticals Ltd 3 Quagen Pharmaceuticals LLC 3 Rising Pharma Holdings, Inc. 3 Sun Pharmaceutical Industries, Inc. 3 A-S Medication Solutions 2 Glenmark Pharmaceuticals Inc., USA 2 Medimetriks Pharmaceuticals, Inc. 2 Royal Pharmaceuticals 2 Actavis Pharma, Inc. 1 Amneal Pharmaceuticals LLC 1 Bausch & Lomb Incorporated 1 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1 Fougera Pharmaceuticals, LLC 1 Lupin Pharmaceuticals,Inc. 1 Patrin Pharma, Inc. 1 Royal Pharmaceuticals, LLC 1

Fluocinolone drug class (RxNorm)

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.

Sources for this Fluocinolone page

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.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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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
Finished products in the current FDA directory
46
Companies listing them (makers, repackagers, distributors)
19
FDA labeler codes behind them ⓘ
20
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 this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Medimetriks Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →