Home › NDC Lookup › Ingredients › Oxiconazole Nitrate › 62559-0285-60
Oxistat oxiconazole nitrate 10 mg/mL Lotion — NDC 62559-0285-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxistat oxiconazole nitrate 10 mg/mL Lotion — NDC 62559-285-60 (Billing 62559-0285-60)

by ANI Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

This is a package of Oxistat oxiconazole nitrate 10 mg/mL Lotion from ANI Pharmaceuticals, Inc., marketed since Sep 2022 and currently FDA-listed; retail pharmacies pay about $11.37 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 62559-0285-60
🏷️ FDA NDC (as labeled) 62559-285-60 billing pads the product segment with a zero
This package
Contains60 mL in 1 bottle Cost per mL$11.37 NADAC Per package$682.01 / 60 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $12.02/unit · Part D plans $23.75/unit — full pricing hub ↓
Main listing for product 62559-285 · Also comes in: 30 mL 62559-285-30 6 bottles 62559-285-06
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 62559-285-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62559 labeler · 285 product · 60 package
Package marketed since
Sep 12, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6255928560 5
Medicaid fills, this package
15 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62559-285-60
Product NDC 62559-285
11-digit billing NDC 62559028560
NCPDP billing unit ML — per mL (volume)
Application # NDA020209
SPL Set ID 64ef2286-0f56-4a8a-b07b-4a597f078ae0
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-12
Route TOPICAL
Dosage form LOTION
Substance OXICONAZOLE NITRATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 017183
GCN 37561
HICL code 003205
Ingredient (HICL) Oxiconazole Nitrate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name OXISTAT 1% LOTION
FDB brand name Oxistat
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 017183
  • GCN: 37561
  • HICL (First Databank): 003205
  • AHFS class code: 84:04.08.08
Why two NDCs? The FDA registers this code as 62559-285-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62559-0285-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name OXISTAT 1% LOTION Ingredient Oxiconazole Nitrate
📖 What it is MedlinePlus · NLM

Oxiconazole, an antifungal agent, is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats fungal skin infections — specifically athlete's foot (the itchy, scaly rash between your toes), jock itch (a rash in the groin area), ringworm (a ring-shaped rash on the...
  • What kinds of infections does oxiconazole actually treat?
  • You may start to see improvement before you finish the full course, but it's important to keep using it for the entire recommended period — 2 weeks for ringworm, jock itch, and tin...
  • How long do I need to use it before it starts working?
📖 Read our full Oxiconazole guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $11.367 $682.01 / 60 ml
Medicaid paysCMS SDUD · 12 mo $12.02 $720.95 / 60 ml
Medicare drug plans payPart D · Q2 2026 $23.75 $1,425.17 / 60 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Jan 2026 $11.367 $11.367
Flat over the last 2 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
62559-0285-06 62559-285-06 6 BOTTLE in 1 CARTON / 7 mL in 1 BOTTLE — — 2022-09-12 — Active
62559-0285-30 62559-285-30 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE — — 2022-09-12 — Active
62559-0285-60 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE $11.37 / mL $682.01 2022-09-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 60 ml in 1 bottle.
What NDC number is used to bill for this package of Oxistat oxiconazole nitrate 10 mg/mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxistat 10 mg/mLthis 62559-0285-60 ANI 1 bottle $11.367 — Availability likely —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 Oxiconazole 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.

  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • 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.
  • 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.
  • 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.
  • 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.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerANI Pharmaceuticals, Inc.
Application holderANI PHARMACEUTICALS INC
FDA applicationNDA020209 (NDA)
Labeler code62559
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio299 products on file

More NDCs from ANI Pharmaceuticals, Inc. labeler code 62559

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

INDICATIONS AND USAGE OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ).

⏱️ Dosage and Administration 67 words ▾

DOSAGE AND ADMINISTRATION OXISTAT Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Tinea corporis and tinea cruris should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS OXISTAT Lotion is contraindicated in individuals who have shown hypersensitivity to any of their components.

⚠️ Warnings 19 words ▾

WARNINGS OXISTAT (oxiconazole nitrate) Lotion, 1% is for topical use only and not for oral, ophthalmic or intravaginal use.

🤒 Adverse Reactions 93 words ▾

ADVERSE REACTIONS In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion , 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each). The following additional adverse experiences have been reported with the topical use of oxiconazole nitrate: irritation and allergic contact dermatitis, folliculitis, erythema, papules, fissure, maceration, rash, and nodules.

To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 15 words ▾

Drug Interactions Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated.

🤰 Pregnancy 83 words ▾

Pregnancy Teratogenic Effects Reproduction studies have been performed in rabbits, rats, and mice at oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m 2 ), respectively, and revealed no evidence of harm to the fetus due to oxiconazole nitrate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 109 words ▾

Geriatric Use A limited number of patients at or above 60 years of age (n ~ 396) have been treated with oxiconazole nitrate cream in US and non-US clinical trials, and a limited number (n = 43) have been treated with OXISTAT Lotion in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. No adverse events were reported with OXISTAT Lotion in geriatric patients, and the adverse reactions reported with oxiconazole nitrate cream in this population were similar to those reported by younger patients.

Based on available data, no adjustment of dosage of OXISTAT Lotion in geriatric patients is warranted.

🆘 Overdosage 63 words ▾

OVERDOSAGE When 5% oxiconazole cream (5 times the concentration of the marketed product) was applied at a rate of 1 g/kg to approximately 10% of body surface area of a group of 40 male and female rats for 35 days, 3 deaths and severe dermal inflammation were reported. No overdoses in humans have been reported with use of oxiconazole nitrate cream or lotion.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm 2 of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 μmol in the epidermis, 3.64 μmol in the upper corium, and 1.29 μmol in the deeper corium. Systemic absorption of oxiconazole nitrate is low.

Using radiolabeled drug, less than 0.3% of the applied dose of oxiconazole nitrate was recovered in the urine of volunteer subjects up to 5 days after application of the cream formulation. Neither in vitro nor in vivo studies have been conducted to establish relative activity between the lotion and cream formulations. Microbiology Oxiconazole nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity.

It has in vitro activity against a wide range of pathogenic fungi. Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites (see INDICATIONS AND USAGE ): Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrum Malassezia furfur The following in vitro data are available; however, their clinical significance is unknown. Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms; however, the safety and efficacy of oxiconazole in treating clinical infections due to these organisms have not been established in adequate and well-controlled clinical trials: Candida albicans Microsporum audouini Microsporum canis Microsporum gypseum Trichophyton tonsurans Trichophyton violaceum

📦 How Supplied / Storage and Handling 73 words ▾

HOW SUPPLIED OXISTAT ® (oxiconazole nitrate) Lotion, 1% is supplied in: 30-mL bottle (NDC 62559-285-30) 60-mL bottle (NDC 62559-285-60) Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Shake well before using. OXISTAT is a registered trademark of Fougera Pharmaceuticals, Inc. and is licensed to ANI Pharmaceuticals, Inc.

Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 N7000 Rev 05/22 logo

📋 Description 124 words ▾

DESCRIPTION OXISTAT ® (oxiconazole nitrate) Lotion, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is for topical dermatologic use only. Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone ( Z )-[ 0 -(2,4-dichlorobenzyl)oxime], mononitrate.

The compound has the molecular formula C 18 H 13 ON 3 Cl 4 ·HNO 3 , a molecular weight of 492.15, and the following structural formula: Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water. OXISTAT Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water, white petrolatum, stearyl alcohol, propylene glycol, polysorbate 60, cetyl alcohol, and benzoic acid 0.2% as a preservative. structure

💬 Information for Patients 137 words ▾

Information for Patients The patient should be instructed to: 1. Use OXISTAT as directed by the physician. The hands should be washed after applying the medication to the affected area(s).

Avoid contact with the eyes, nose, mouth, and other mucous membranes. OXISTAT is for external use only. 2.

Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks, or sooner if the condition worsens (see below). 3.

Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. 4. Avoid the use of occlusive dressings unless otherwise directed by the physician.

5. Do not use this medication for any disorder other than that for which it was prescribed.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General OXISTAT Lotion is for external dermal use only. Avoid introduction of OXISTAT Lotion into the mouth, eyes, or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of OXISTAT Lotion, treatment should be discontinued and appropriate therapy instituted.

If signs of epidermal irritation should occur, the drug should be discontinued. Information for Patients The patient should be instructed to: 1. Use OXISTAT as directed by the physician.

The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. OXISTAT is for external use only.

2. Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks, or sooner if the condition worsens (see below).

3. Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. 4.

Avoid the use of occlusive dressings unless otherwise directed by the physician. 5. Do not use this medication for any disorder other than that for which it was prescribed.

Drug Interactions Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated. Carcinogenesis, Mutagenesis, Impairment of Fertility Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no evidence of mutagenic effect was found in 2 mutation assays (Ames test and Chinese hamster V79 in vitro cell mutation assay) or in 2 cytogenetic assays (human peripheral blood lymphocyte in vitro chromosome aberration assay and in vivo micronucleus assay in mice).

Reproductive studies revealed no impairment of fertility in rats at oral doses of 3 mg/kg/day in females (1 time the human dose based on mg/m 2 ) and 15 mg/kg/day in males (4 times the human dose based on mg/m 2 ). However, at doses above this level, the following effects were observed: a reduction in the fertility parameters of males and females, a reduction in the number of sperm in vaginal smears, extended estrous cycle, and a decrease in mating frequency. Pregnancy Teratogenic Effects Reproduction studies have been performed in rabbits, rats, and mice at oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m 2 ), respectively, and revealed no evidence of harm to the fetus due to oxiconazole nitrate.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Because oxiconazole is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use A limited number of patients at or above 60 years of age (n ~ 396) have been treated with oxiconazole nitrate cream in US and non-US clinical trials, and a limited number (n = 43) have been treated with OXISTAT Lotion in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety.

No adverse events were reported with OXISTAT Lotion in geriatric patients, and the adverse reactions reported with oxiconazole nitrate cream in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of OXISTAT Lotion in geriatric patients is warranted.

🍼 Nursing Mothers 22 words ▾

Nursing Mothers Because oxiconazole is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.

🧬 Pharmacokinetics 123 words ▾

Pharmacokinetics The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm 2 of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 μmol in the epidermis, 3.64 μmol in the upper corium, and 1.29 μmol in the deeper corium. Systemic absorption of oxiconazole nitrate is low.

Using radiolabeled drug, less than 0.3% of the applied dose of oxiconazole nitrate was recovered in the urine of volunteer subjects up to 5 days after application of the cream formulation. Neither in vitro nor in vivo studies have been conducted to establish relative activity between the lotion and cream formulations.

🔬 Clinical Studies ~1 min read ▾

CLINICAL STUDIES The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trial that form the basis for the approval of OXISTAT Lotion. Definitions 1. Mycological Cure: No evidence (culture and KOH preparation) of the baseline (original) pathogen in a specimen from the affected area taken at the 2-week post-treatment visit (for tinea [pityriasis] versicolor, mycological cure was limited to KOH only).

2. Treatment Success: Both a global evaluation of 90% clinical improvement and a microbiologic eradication (see above) at the 2-week post-treatment visit. Tinea Pedis The clinical trial for the lotion formulation line extension involved 332 evaluable patients with clinically and microbiologically established tinea pedis.

Of these evaluable patients, 64% were diagnosed with hyperkeratotic plantar tinea pedis and 28% with interdigital tinea pedis. Seventy-seven percent (77%) had disease secondary to infection with Trichophyton rubrum, 18% had disease secondary to infection with Trichophyton mentagrophytes , and 4% had disease secondary to infection with Epidermophyton floccosum. The results of this clinical trial at the 2-week post-treatment follow-up visit are shown in the following table: Patient Outcome OXISTAT Lotion Vehicle b.i.d. q.d.

Mycological cure 67% 64% 28% Treatment success 41% 34% 10% In this study, the improvement and cure rates of the b.i.d.- and q.d.-treated groups did not differ significantly (95% confidence interval) from each other but were statistically (95% confidence interval) superior to the vehicle-treated group.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 143 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no evidence of mutagenic effect was found in 2 mutation assays (Ames test and Chinese hamster V79 in vitro cell mutation assay) or in 2 cytogenetic assays (human peripheral blood lymphocyte in vitro chromosome aberration assay and in vivo micronucleus assay in mice). Reproductive studies revealed no impairment of fertility in rats at oral doses of 3 mg/kg/day in females (1 time the human dose based on mg/m 2 ) and 15 mg/kg/day in males (4 times the human dose based on mg/m 2 ).

However, at doses above this level, the following effects were observed: a reduction in the fertility parameters of males and females, a reduction in the number of sperm in vaginal smears, extended estrous cycle, and a decrease in mating frequency.

📄 Package Label / Principal Display Panel 34 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 62559- 285 -30 OXISTAT® (oxiconazole nitrate) Lotion, 1%* *Potency expressed as oxiconazole. For Topical Dermatologic Use ONLY. Not for Oral, Ophthalmic or Intravaginal Use. Rx only 30 mL Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
15
Units reimbursed last 4 qtrs
900
Gross reimbursed last 4 qtrs
$10.8K
Avg / prescription
$720.95
Avg / unit
$12.0158
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$12.0158
gross reimbursed
vs
NADAC / mL
$11.3669
acquisition cost
=
Spread
+$0.6489
+6% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 15 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 900 units · 4.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.64.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 4.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page62559-0285-60 15 Rx · $10,814
6 bottles62559-0285-06 No Medicaid data
1 bottle62559-0285-30 No Medicaid data
Drug total (last 4 qtrs): 15 Rx · 900 units · $10,814 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Oxistat — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Oxistat. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$168K
Claims incl. refills
209
Beneficiaries
117
Spend / beneficiary
$1,435.94
Spend / claim
$803.85
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oxistat (this brand).

Top reported reactions

Rash16
Pruritus13
Arthralgia10
Headache10
Chronic Kidney Disease8
Erythema8
Nausea8

Age at onset

Neonate1
Adult12
Elderly5

Reporter sex

171 reports
Male · 40%
Female · 60%

Serious outcomes

Hospitalization35
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 16 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 62559-0280-01 · ANI 62559-0288-15 · ANI →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.