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Oxiconazole Nitrate 10 mg/g Cream — NDC 51672-1359-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxiconazole Nitrate 10 mg/g Cream — NDC 51672-1359-1 (Billing 51672-1359-01)

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Oxiconazole Nitrate 10 mg/g Cream from Sun Pharmaceutical Industries, Inc., marketed since Mar 2016 and currently FDA-listed.

NDC 51672-1359-01
🏷️ FDA NDC (as labeled) 51672-1359-1 billing pads the package segment with a zero
This package
Contains15 g in 1 tube Pack sizes4 compare ↓
Also priced by: Part D plans $5.21/unit — full pricing hub ↓
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 51672-1359-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51672 labeler · 1359 product · 1 package
Package marketed since
Mar 7, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5167213591 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-1359-1
Product NDC 51672-1359
11-digit billing NDC 51672135901
RxCUI 312139
UNII RQ8UL4C17S
Application # ANDA205076
SPL Set ID 04477378-cccc-4db3-9e1b-5c1d6a00bd13
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-03-07
Route TOPICAL
Dosage form CREAM
Substance OXICONAZOLE NITRATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90154065003710
GPI class Oxiconazole Nitrate
GCN Seq No 007375
GCN 46920
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 OXICONAZOLE NITRATE 1% CREAM
FDB brand name Oxiconazole Nitrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007375
  • GCN: 46920
  • GPI-14 (Medi-Span): 90154065003710
  • HICL (First Databank): 003205
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 312139
Why two NDCs? The FDA registers this code as 51672-1359-1 — a 5-4-1 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 package segment → 51672-1359-01. 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.

RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Imidazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name OXICONAZOLE NITRATE 1% CREAM 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 →
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 gPer 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 $5.21 $78.13 / 15 g
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
51672-1359-01 You're viewing this 1 TUBE in 1 CARTON / 15 g in 1 TUBE — — 2016-03-07 — Active
51672-1359-02 51672-1359-2 Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE $4.10 / g $123.07 2016-03-07 — Active
51672-1359-03 51672-1359-3 1 TUBE in 1 CARTON / 60 g in 1 TUBE $4.79 / g $287.31 2016-03-07 — Active
51672-1359-08 51672-1359-8 1 TUBE in 1 CARTON / 90 g in 1 TUBE $3.73 / g $335.77 2016-03-07 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries the largest share of fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Oxiconazole Nitrate 10 mg/g Cream?
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
Oxiconazole Nitrate 10 mg/g 00168-0358-30 E. 30 g $4.102 AB Availability likely —
Oxiconazole Nitrate 10 mg/gthis 51672-1359-01 Sun 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA205076 (ANDA)
Labeler code51672
First marketedMar 2016
Product typeHuman Prescription Drug
Portfolio890 products on file
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 104 words ▾

INDICATIONS AND USAGE Oxiconazole nitrate cream 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 . Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ). Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.

⏱️ Dosage and Administration 172 words ▾

DOSAGE AND ADMINISTRATION Oxiconazole nitrate cream should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole nitrate cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor 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. Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites.

Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.

⚠️ Warnings 11 words ▾

WARNINGS Oxiconazole nitrate cream is not for ophthalmic or intravaginal use.

🤒 Adverse Reactions 101 words ▾

ADVERSE REACTIONS During clinical trials, of 955 patients treated with oxiconazole nitrate cream , 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each). 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).

🔄 Drug Interactions 17 words ▾

Drug Interactions Potential drug interactions between oxiconazole nitrate cream and other drugs have not been systematically evaluated.

🤰 Pregnancy 86 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B 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 45 words ▾

Pediatric Use Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.

🧓 Geriatric Use 112 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 oxiconazole nitrate 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 oxiconazole nitrate 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 oxiconazole nitrate cream 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 46 words ▾

HOW SUPPLIED Oxiconazole Nitrate Cream, 1% is supplied in: 15 g tubes - (NDC 51672-1359-1) 30 g tubes - (NDC 51672-1359-2) 60 g tubes - (NDC 51672-1359-3) 90 g tubes - (NDC 51672-1359-8) Store at 20° – 25°C (68° – 77°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 13 words ▾

Store at 20° – 25°C (68° – 77°F) [See USP Controlled Room Temperature].

📋 Description 123 words ▾

DESCRIPTION Oxiconazole nitrate cream, 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 CI 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. Oxiconazole nitrate cream, 1% contains 10 mg of oxiconazole per gram of cream in a white to off-white cream base of cetyl alcohol, polysorbate 60, propylene glycol, purified water, stearyl alcohol, white petrolatum, and benzoic acid 0.2% as a preservative.

Chemical Structure

💬 Information for Patients 136 words ▾

Information for Patients The patient should be instructed to: Use oxiconazole nitrate cream 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.

Oxiconazole nitrate cream is for external use only. 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).

Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. Avoid the use of occlusive dressings unless otherwise directed by the physician. Do not use this medication for any disorder other than that for which it was prescribed.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Oxiconazole nitrate cream is for external dermal use only. Avoid introduction of oxiconazole nitrate cream into the eyes or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of oxiconazole nitrate cream, 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: Use oxiconazole nitrate cream 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. Oxiconazole nitrate cream is for external use only. 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). Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. Avoid the use of occlusive dressings unless otherwise directed by the physician.

Do not use this medication for any disorder other than that for which it was prescribed. Drug Interactions Potential drug interactions between oxiconazole nitrate cream 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 Pregnancy Category B 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 Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12. 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 oxiconazole nitrate 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 oxiconazole nitrate 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 oxiconazole nitrate cream 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 ~3 min read ▾

CLINICAL STUDIES The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trials that form the basis for the approvals of Oxiconazole nitrate lotion and Oxiconazole nitrate cream. Definitions 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). 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 THERE ARE NO HEAD-TO-HEAD COMPARISON TRIALS OF THE OXICONAZOLE NITRATE CREAM AND LOTION FORMULATIONS IN THE TREATMENT OF TINEA PEDIS. Lotion Formulation 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 Oxiconazole nitrate lotion Vehicle b.i.d q.d. Myocological 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.

Cream Formulation The two pivotal trials for the cream formulation involved 281 evaluable patients (total from both trials) with clinically and microbiologically established tinea pedis. The combined results of these two clinical trials at the 2-week post-treatment follow-up visit are shown in the following table: Patient Outcome Oxiconazole nitrate cream Vehicle b.i.d q.d. Myocological cure 77% 79% 33% Treatment success 52% 43% 14% All 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.

In addition, pediatric data (95 children ages 10 and under) available with the cream formulation indicate that it is safe and effective for use in children when used as directed. Adverse events were reported in 2 children; 1 child was reported to have reddening of the skin and 1 child was reported to have eczema-like skin alterations. Tinea (pityriasis) Versicolor Two pivotal clinical trials of oxiconazole nitrate cream in tinea (pityriasis) versicolor involved 219 evaluable patients in the q day oxiconazole nitrate and vehicle arms of the trial with clinical and mycological evidence of tinea (pityriasis) versicolor.

Patients were treated for 2 weeks with oxiconazole nitrate cream once daily, or with cream vehicle. The combined results of these clinical trials at the 2-week post-treatment follow-up visit are shown in the following table. These results are based on 207 patients (110 in the oxiconazole nitrate group and 97 in the vehicle group) with efficacy evaluations at this visit.

Patient Outcome Oxiconazole nitrate cream Vehicle q.d. Myocological cure 88% 67% Treatment success 83% 62% Only once a day was shown in both studies to be statistically superior to vehicle for all efficacy parameters at 2 weeks and follow-up.

📄 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 54 words ▾

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton NDC 51672-1359-1 15 g Oxiconazole Nitrate Cream , 1%* *Potency expressed as oxiconazole. For Topical Dermatological Use Only. Not for Ophthalmic or Intravaginal Use. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

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

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 tube51672-1359-02 4,053 Rx · $1,908,776
1 tube51672-1359-08 3,352 Rx · $918,544
1 tube51672-1359-03 1,014 Rx · $309,118
Drug total (last 4 qtrs): 8,419 Rx · 477,603 units · $3,136,437 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 · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Oxiconazole Nitrate — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Oxiconazole Nitrate. 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.
Period
Total Part D spend
$1.23M
Claims incl. refills
2.8K
Beneficiaries
1.5K
Spend / beneficiary
$799.36
Spend / claim
$441.74
Trend by period
💵 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.

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (51672-1359-02), 1 tube (51672-1359-03), 1 tube (51672-1359-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.