Fluocinonide .5 mg/g Cream — NDC 0713-0664-31 (Billing 00713-0664-31)
This is a package of Fluocinonide .5 mg/g Cream from Cosette Pharmaceuticals, Inc., marketed since Mar 2016 and currently FDA-listed; retail pharmacies pay about $0.7671 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0713-0664-31 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0713 labeler · 0664 product · 31 package
- Package marketed since
- Oct 9, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0307130664608
- Medicaid fills, this package
- 11 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 007614
- GCN: 54650
- GPI-14 (Medi-Span): 90550060103705
- HICL (First Databank): 003317
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 1801283
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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
- 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.767 | $23.01 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.7215 | $21.65 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.6687 | $20.06 / 30 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00713-0664-15 0713-0664-15 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.9060 / g | $13.59 | 2018-10-09 | — | Active |
| 00713-0664-31 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.7671 / g | $23.01 | 2018-10-09 | — | Active |
| 00713-0664-60 0713-0664-60 Main listing | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $0.6050 / g | $36.30 | 2018-10-09 | — | Active |
Per g, this pack runs about 27% above the cheapest pack (NDC 00713-0664-60, $0.6050 vs $0.7671 NADAC).
This pack accounts for about 1.3% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Fluocinonide .5 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluocinonide .5 mg/g 00713-0663-15 | Cosette | 1 tube | $0.367 | AB1 | Availability likely | save 52% |
| Fluocinonide .5 mg/g 00093-0262-15 | Teva | 1 tube | $0.367 | AB1 | Discontinued | save 52% |
| Fluocinonide .5 mg/g 51672-1386-01 | Sun | 1 tube | $0.367 | AB1 | Availability likely | save 52% |
| Fluocinonide .5 mg/g 51672-1264-01 | Sun | 1 tube | $0.368 | AB | Availability likely | save 52% |
| Fluocinonide .5 mg/g 00093-0264-15 | Teva | 1 tube | $0.368 | AB | Discontinued | save 52% |
| Fluocinonide .5 mg/g 21922-0064-03 | Encube | 1 tube | $0.472 | AB1 | Availability likely | save 38% |
| Fluocinonide Cream .5 mg/g 69238-1534-02 | Amneal | 1 tube | $0.472 | AB1 | Availability likely | save 38% |
| Fluocinonide .5 mg/gthis 00713-0664-31 | Cosette | 1 tube | $0.767 | AB2 | Availability likely | — |
| Fluocinonide .5 mg/g 00093-0263-15 | Teva | 1 tube | $0.906 | AB2 | Discontinued | +18% |
| Fluocinonide .5 mg/g 51672-1254-01 | Sun | 1 tube | $0.906 | AB2 | Availability likely | +18% |
| Fluocinonide .5 mg/g 45802-0761-15 | Padagis | 1 tube | $1.084 | AB | Availability likely | +41% |
| Fluocinonide .5 mg/g 51672-1279-01 | Sun | 1 tube | $1.084 | AB | Availability likely | +41% |
| Fluocinonide .5 mg/g 50090-3277-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-4921-05 | NuCare | 30 g | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68788-8593-06 | Preferred | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-6309-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-4219-05 | NuCare | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68788-8554-06 | Preferred | 1 tube | — | AB | FDA listed | — |
| Fluocinonide .5 mg/g 66267-0973-15 | NuCare | 15 g | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-2202-05 | NuCare | 1 tube | — | AB | FDA listed | — |
| Fluocinonide .5 mg/g 50090-1784-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-7923-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 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 Oct 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.
🧪 Avoiding an ingredient? See Fluocinonide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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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.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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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.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
More NDCs from Cosette Pharmaceuticals, Inc. labeler code 00713
- Halobetasol Propionate .5 mg/g Cream NDC 0713-0640-15
- Triamcinolone Acetonide 1 mg/g Paste NDC 0713-0655-40
- Clobetasol Propionate .5 mg/g Ointment NDC 0713-0656-15
- Betamethasone Dipropionate .5 mg/g Cream NDC 0713-0659-15
- Desonide .5 mg/g Cream NDC 0713-0661-15
- Fluocinonide .5 mg/g Cream NDC 0713-0663-15
- Tazarotene 1 mg/g Cream NDC 0713-0670-31
- Triamcinolone Acetonide 1 mg/mL Lotion NDC 0713-0676-53
- Nystatin 100000 [USP'U]/g Cream NDC 0713-0678-15
- Gentamicin Sulfate 1 mg/g Ointment NDC 0713-0682-15
- Gentamicin Sulfate 1 mg/g Cream NDC 0713-0683-15
- Nystatin 100000 [USP'U]/g Ointment NDC 0713-0686-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluocinonide Cream USP, 0.05% (Emulsified Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Fluocinonide Cream, USP 0.05% (Emulsified Base) is generally applied to the affected area as a thin film from two to four times daily, as needed. 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, USP 0.05% 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 Hypertrichosis Maceration of the Skin Itching Acneiform Eruptions Secondary Infection Irritation Hypopigmentation Skin Atrophy Dryness Perioral Dermatitis Striae Folliculitis Allergic Contact Dermatitis 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 .
🤰 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 hypothalamic-pituitary- adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. 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, anti-pruritic 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0713-0664-15), 30 g (NDC 0713-0664-31) and 60 g (NDC 0713-0664-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Distributed by: Cosette Pharmaceuticals,Inc. South Plainfield, NJ 07080 VC7673 Rev. 09/2022 8-0664CPLNC3
📋 Description ▾
DESCRIPTION Fluocinonide Cream, USP 0.05% (Emulsified Base) 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)]-, (6α ,11β,16α )-. It has the following chemical structure: Mol.
Formula: C 26 H 32 F 2 O 7 Mol. Wt: 494.53 Fluocinonide Cream, USP 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol. molecular-structure
💬 Information for Patients ▾
Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions, especially under occlusive dressing.
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
🍼 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. 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.
📄 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 ▾
PRINCIPAL DISPLAY PANEL NDC 0713-0664-15 Fluocinonide Cream,USP (Emulsified Base) 0.05% 15 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc.
NDC 0713-0664-31 Fluocinonide Cream,USP (Emulsified Base) 0.05 30 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc.
NDC 0713-0664-60 Fluocinonide Cream,USP (Emulsified Base) 0.05% 60 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc.
15gm-carton 30gm-carton 60gm-carton