fluocinonide .5 mg/mL Solution — NDC 0168-0134-60 (Billing 00168-0134-60)
This is a package of fluocinonide .5 mg/mL Solution from E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, marketed since Feb 1995 and currently FDA-listed; retail pharmacies pay about $0.2049 per mL (NADAC). It is this product's only package size.
Other active recalls for Fluocinonide (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007618
- GCN: 31401
- GPI-14 (Medi-Span): 90550060002005
- HICL (First Databank): 003318
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 310364
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 ↗- It calms redness, swelling and itching from skin conditions that respond to steroids. The 0.1% creams, including Vanos, are for people 12 and older, and the label specifically desc...
- Use a thin layer on the affected skin only. Follow the schedule on your label and from your prescriber, which differs between the 0.1% creams and the 0.05% products. Don't cover th...
- No. The 0.1% creams are not for the face, groin or underarms. Also keep all of it out of your eyes, mouth and vagina.
- The 0.1% creams are not recommended beyond 2 consecutive weeks. Stop once the condition is controlled, and tell your doctor if you see no improvement in 2 weeks.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.205 | $12.29 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.3396 | $20.38 / 60 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.4094 | $24.56 / 60 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00168-0134-60 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | 1995-02-27 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| fluocinonide .5 mg/mLthis 00168-0134-60 | E. | 1 bottle | $0.205 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 21922-0001-01 | Encube | 1 bottle | $0.205 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 70710-1284-03 | Zydus | 60 ml | $0.205 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 70752-0154-05 | QUAGEN | 1 bottle | $0.205 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 72603-0703-01 | NorthStar | 1 bottle | $0.205 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 33342-0320-84 | Macleods | 1 bottle | $0.314 | AT | Availability likely | +53% |
| Fluocinonide .5 mg/mL 43386-0026-02 | Lupin | 1 bottle | $0.314 | AT | Availability likely | +53% |
| Fluocinonide .5 mg/mL 51672-1273-02 | Sun | 1 bottle | $0.314 | AT | Availability likely | +53% |
| fluocinonide .5 mg/mL 40032-0026-06 | Novel | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 63629-9583-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 68071-3918-06 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 70771-1375-03 | Zydus | 60 ml | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 71656-0094-20 | Saptalis | 20 ml | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 72162-1270-06 | Bryant | 1 bottle | — | AT | FDA listed | — |
| fluocinonide .5 mg/mL 72162-2146-06 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 72162-2490-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Sep 3, 2026
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.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII P7E6YFV72X
Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
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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.
4 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Fluocinonide Topical Solution 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 Topical Solution USP, 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: Topical corticosteroids are 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 and miliaria.
🤰 Pregnancy ▾
Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
🧒 Pediatric Use ▾
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
🆘 Overdosage ▾
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts 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. A significantly greater amount of fluocinonide is absorbed from the solution than from cream or gel formulations.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase the 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 Topical Solution USP, 0.05% is supplied in: 60 mL bottles NDC 0168-0134-60. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat above 40°C (104°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2134D R07/13 #49
📋 Description ▾
DESCRIPTION: Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-).
It has a molecular formula of C 26 H 32 F 2 O 7 and a molecular weight of 494.54. It has the following structural formula: Each mL of Fluocinonide Topical Solution USP, 0.05% contains: fluocinonide 0.5 mg in a solution of alcohol (35%), diisopropyl adipate, citric acid and propylene glycol. In this formulation, the active ingredient is totally in solution. chemical structure
💬 Information for Patients ▾
Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. If there is contact with the eye(s) and severe irritation occurs, immediately flush with large volume of water. 2.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressings. 5.
Parents of pediatric patients should be advised not to use tight fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
⚠️ Precautions ▾
PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, the addition of occlusive dressings and dosage form. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use ). This preparation is not for ophthalmic use. Severe irritation is possible if fluocinonide topical solution contacts the eye.
If that should occur, immediate flushing of the eye with a large volume of water is recommended. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues.
When used on intertriginous or flexor areas, or on the face, this may occur even with short term use. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. If there is contact with the eye(s) and severe irritation occurs, immediately flush with large volume of water. 2.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressings. 5.
Parents of pediatric patients should be advised not to use tight fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test; ACTH stimulation test. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
🧬 Pharmacokinetics ▾
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. A significantly greater amount of fluocinonide is absorbed from the solution than from cream or gel formulations. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase the 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CONTAINER NDC 0168-0134-60 FOUGERA ® FLUOCINONIDE TOPICAL SOLUTION USP, 0.05% 60 mL FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Fluocinonide Topl Soln USP, 0.05% Label
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CARTON NDC 0168-0134-60 FOUGERA ® FLUOCINONIDE TOPICAL SOLUTION USP, 0.05% 60 mL FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Fluocinonide Topl Soln USP, 0.05% Carton 60mL