Ciclopirox Olamine 7.7 mg/g Cream — NDC 0713-0638-15 (Billing 00713-0638-15)
This is a package of Ciclopirox Olamine 7.7 mg/g Cream from Cosette Pharmaceuticals, Inc., marketed since May 2007 and currently FDA-listed; retail pharmacies pay about $0.2077 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0713-0638-15 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0713 labeler · 0638 product · 15 package
- Package marketed since
- May 22, 2007
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0307130638159
- Medicaid fills, this package
- 1,663 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 040971
- GCN: 94677
- GPI-14 (Medi-Span): 90150030103705
- HICL (First Databank): 003203
- AHFS class code: 84:04.08.20
- RxCUI (RxNorm): 309289
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 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 Other antifungals for topical use class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.
Read the full MedlinePlus article ↗- It's treating a fungal infection living inside your nail. Ciclodan (the 8% nail lacquer solution) works specifically on onychomycosis — a fungal infection of the nail plate caused...
- What is this medicine actually treating — my nail or a skin infection?
- Nail infections are slow to treat because nails grow slowly. Clinical studies used ciclopirox nail lacquer for 48 weeks — that's nearly a year. Even then, complete clearing of the...
- How long will I have to use this before I see results?
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 6, 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 | $0.208 | $3.12 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4869 | $7.30 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3074 | $4.61 / 15 g |
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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00713-0638-15 You're viewing this | 1 TUBE in 1 BOX / 15 g in 1 TUBE | $0.2077 / g | $3.11 | 2007-05-22 | — | Active |
| 00713-0638-18 0713-0638-18 | 1 TUBE in 1 BOX / 90 g in 1 TUBE | $0.1025 / g | $9.23 | 2007-05-22 | — | Active |
| 00713-0638-31 0713-0638-31 Main listing | 1 TUBE in 1 BOX / 30 g in 1 TUBE | $0.1687 / g | $5.06 | 2007-05-22 | — | Active |
Per g, this pack runs about 103% above the cheapest pack (NDC 00713-0638-18, $0.1025 vs $0.2077 NADAC).
This pack accounts for about 17% of this product's recent Medicaid fills; the largest share goes 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 Ciclopirox Olamine 7.7 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 |
|---|---|---|---|---|---|---|
| Ciclopirox olamine 7.7 mg/g 45802-0138-11 | Padagis | 1 tube | $0.169 | AB | Availability likely | save 19% |
| Ciclopirox Olamine 7.7 mg/gthis 00713-0638-15 | Cosette | 1 tube | $0.208 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/g 51672-1318-01 | Sun | 1 tube | $0.208 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/g 68462-0297-17 | Glenmark | 15 g | $0.208 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/g 63629-8624-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/g 63629-8625-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox olamine 7.7 mg/g 63629-8626-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox olamine 7.7 mg/g 71335-2865-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/g 72162-1397-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/g 80425-0225-01 | Advanced | 30 g | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 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 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 Ciclopirox Topical 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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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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 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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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 V42034O9PU
A fatty alcohol derived from coconut or palm oil. It serves as an emulsifier and thickener to help blend oil and water in creams or lotions, and improves the product's texture and consistency.
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UNII 461N1O614Y
A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
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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 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.
10 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 6, 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
More NDCs from Cosette Pharmaceuticals, Inc. labeler code 00713
- Fluticasone Propionate .5 mg/g Cream NDC 0713-0631-15
- Fluticasone Propionate .05 mg/g Ointment NDC 0713-0632-15
- Metronidazole 7.5 mg/g Cream NDC 0713-0633-37
- Mometasone Furoate 1 mg/g Cream NDC 0713-0634-15
- Mometasone Furoate 1 mg/g Ointment NDC 0713-0635-15
- Metronidazole 7.5 mg/g Gel NDC 0713-0637-37
- 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
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 Ciclopirox Olamine Cream USP, 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis ; candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur .
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gently massage Ciclopirox Olamine Cream USP into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritis and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with Ciclopirox Olamine Cream, the diagnosis should be redetermined.
Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
⛔ Contraindications ▾
CONTRAINDICATIONS Ciclopirox Olamine Cream USP is contraindicated in individuals who have shown hypersensitivity to any of its components.
⚠️ Warnings and Cautions ▾
PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Olamine Cream, treatment should be discontinued and appropriate therapy instituted.
⚠️ Warnings ▾
WARNINGS Ciclopirox Olamine Cream USP is not for ophthalmic use. Keep out of reach of children.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In all controlled clinical studies with 514 patients using Ciclopirox Olamine Cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. 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 Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Olamine Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys.
Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 11, 37, 51 and 24 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400.
Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 27 and 49 times the maximum recommended human dose based on body surface area comparisons, respectively.)
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 years have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe 3+ or A1 3+ ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. Pharmacokinetics Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm 2 on the back followed by occlusion for 6 hours.
The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.
Penetration studies in human cadaverous skin from the back, with Ciclopirox Olamine Cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations. Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.
Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to Ciclopirox Olamine Cream.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ciclopirox Olamine Cream USP, 0.77% is supplied in: 15-g tubes (NDC 0713-0638-15) 30-g tubes (NDC 0713-0638-31) 90-g tubes (NDC 0713-0638-18) Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0638CPLNC2 VC7640 Rev. 06/2022
📋 Description ▾
DESCRIPTION Ciclopirox Olamine Cream USP, 0.77% is for topical use. Each gram of Ciclopirox Olamine Cream USP contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of purified water USP, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, cocamide DEA, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as preservative. Ciclopirox Olamine Cream USP contains a synthetic, broad spectrum, antifungal agent ciclopirox (as ciclopirox olamine).
The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is: structure
💬 Information for Patients ▾
Information for Patients The patient should be told to: 1. Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks. 2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Olamine Cream is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m 2 /day). No increase in drug related neoplasms was noted when compared to control. The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe 3+ , with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative).
An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight. A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine.
No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.2 times the maximum recommended human dose based on body surface area comparisons).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL ND C 0713-0638-15 Ciclopirox Olamine Cream, USP (Ciclopirox Cream) 0.77% 15g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR USE IN EYES Cosette Pharmaceuticals, Inc. NDC 0713-0638-31 Ciclopirox Olamine Cream, USP (Ciclopirox Cream) 0.77% 30 g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR USE IN EYES Cosette Pharmaceuticals, Inc. NDC 0713-0638-18 Ciclopirox Olamine Cream, USP (Ciclopirox Cream) 0.77% 90 g Rx only FOR DERMATOLOGIC USE ONLY - NOT FOR USE IN EYES Cosette Pharmaceuticals, Inc. carton 15g tube 15 carton 30 tube 30 carton 90 tube 90