Fluocinonide .5 mg/g Cream
Other active recalls for Fluocinonide (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- Fluocinonide is used to calm inflamed, itchy skin — things like eczema (atopic dermatitis), psoriasis, and other inflammatory skin conditions that respond to steroid treatment. It...
- What skin problems does fluocinonide actually treat?
- Use a thin layer — just enough to cover the affected area — and rub it in gently. How often you apply it depends on your product and condition: some people use it once a day, other...
- That's a really common feeling with skin conditions, but with the 0.1% strength products, treatment beyond 2 consecutive weeks is generally not recommended because of the risk of t...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII W45XXM0XWE
A humectant and solvent derived from plant oils or synthesized chemically. It draws moisture into the product to keep it soft and helps dissolve or mix other ingredients together in liquid formulations.
-
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.6687 | $40.12 / 60 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluocinonide .5 mg/g 51672-1264-01 | Sun | 1 tube | $0.339 | AB | Availability likely | — |
| Fluocinonide .5 mg/g 00093-0264-15 | Teva | 1 tube | $0.339 | AB | Discontinued | — |
| Fluocinonide .5 mg/g 00093-0262-15 | Teva | 1 tube | $0.415 | AB1 | Discontinued | — |
| Fluocinonide .5 mg/g 00713-0663-15 | Cosette | 1 tube | $0.415 | AB1 | Availability likely | — |
| Fluocinonide .5 mg/g 51672-1386-01 | Sun | 1 tube | $0.415 | AB1 | Availability likely | — |
| Fluocinonide .5 mg/g 21922-0064-03 | Encube | 1 tube | $0.504 | AB1 | Availability likely | — |
| Fluocinonide Cream .5 mg/g 69238-1534-02 | Amneal | 1 tube | $0.504 | AB1 | Availability likely | — |
| Fluocinonide .5 mg/g 00713-0664-15 | Cosette | 1 tube | $0.943 | AB2 | Availability likely | — |
| Fluocinonide .5 mg/g 00093-0263-15 | Teva | 1 tube | $0.943 | AB2 | Discontinued | — |
| Fluocinonide .5 mg/g 51672-1254-01 | Sun | 1 tube | $0.943 | AB2 | Availability likely | — |
| Fluocinonide .5 mg/g 45802-0761-15 | Padagis | 1 tube | $1.149 | AB | Availability likely | — |
| Fluocinonide .5 mg/g 51672-1279-01 | Sun | 1 tube | $1.149 | AB | Availability likely | — |
| Fluocinonide .5 mg/g 50090-1784-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-3277-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-6309-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-7923-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 66267-0973-15 | NuCare | 15 g | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-4219-05 | NuCare | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-4921-05 | NuCare | 30 g | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/gthis 68788-8593-06 | Preferred | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68788-8554-06 | Preferred | 1 tube | — | AB | FDA listed | — |
| Fluocinonide .5 mg/g 68071-2202-05 | NuCare | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68788-8593-06 You're viewing this | 1 TUBE in 1 CARTON (68788-8593-6) / 60 g in 1 TUBE | 2024-02-23 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluocinonide Cream, USP 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Fluocinonide cream 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
⛔ Contraindications ▾
CONTRAINDICATIONS Fluocinonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.
(See DOSAGE AND ADMINISTRATION .) Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluocinonide Cream, USP 0.05% is supplied in 60 g (NDC 68788-8593-6) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 09/2021 8-0663CPLNC1 VC7594 Relabeled By: Preferred Pharmaceuticals Inc.
📋 Description ▾
DESCRIPTION Fluocinonide Cream, USP 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6∝,11ß,16∝). Its molecular formula is C 26 H 32 F 2 O 7 , and has the molecular weight of 494.53.
It has the following chemical structure: Fluocinonide Cream, USP 0.05% contains fluocinonide 0.5 mg/g in a cream base consisting of citric acid, 1,2,6-hexanetriol, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties.
In the Fluocinonide Cream, USP 0.05% formulation, the active ingredient is totally in solution. structural formula