Ciclopirox Olamine 7.7 mg/mL Suspension — NDC 45802-400-46 (Billing 45802-0400-46)
This is a package of Ciclopirox Olamine 7.7 mg/mL Suspension from Padagis Israel Pharmaceuticals Ltd, marketed since Dec 2006 and currently FDA-listed; retail pharmacies pay about $0.7215 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 45802-400-46 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 400 product · 46 package
- Package marketed since
- Dec 29, 2006
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 4580240046 8
- Medicaid fills, this package
- 7,907 prescriptions in the last four reported quarters
- FDA record last changed
- Aug 20, 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): 040298
- GCN: 95353
- HICL (First Databank): 003203
- AHFS class code: 84:04.08.20
- RxCUI (RxNorm): 309290
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 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 8, 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.722 | $43.29 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.22 | $73.03 / 60 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.14 | $68.11 / 60 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 45802-0400-46 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | $0.7215 / mL | $43.29 | 2006-12-29 | — | Active |
| 45802-0400-49 45802-400-49 | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE | $0.8094 / mL | $24.28 | 2006-12-29 | — | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.7215 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 68% of fills over the last four reported quarters. 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/mL Suspension?
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/mLthis 45802-0400-46 | Padagis | 1 bottle | $0.722 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/100mL 63629-2522-01 | Bryant | 1 bottle | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/100mL 63629-8627-01 | Bryant | 1 bottle | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/100mL 71335-2717-01 | Bryant | 1 bottle | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/100mL 71335-2915-01 | Bryant | 1 bottle | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/100mL 72162-1406-03 | Bryant | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See 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 N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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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 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802
- testosterone 40.5 mg/2.5g Gel NDC 45802-366-65
- Imiquimod 12.5 mg/.25g Cream NDC 45802-368-53
- Betamethasone Dipropionate .5 mg/g Cream NDC 45802-376-32
- Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g Gel NDC 45802-383-01
- Tacrolimus .3 mg/g Ointment NDC 45802-390-00
- gynazole 1 butoconazole nitrate 100 mg/5g Cream NDC 45802-396-01
- Ciclopirox 1 g/100mL Shampoo NDC 45802-401-09
- Alogliptin and Pioglitazone 25 mg; 30 mg Tablet, Film Coated NDC 45802-402-65
- oxymetazoline hcl oxymetazoline hydrochloride .05 g/100mL Spray NDC 45802-410-59
- Ammonium Lactate 12 g/100g Lotion NDC 45802-419-26
- Desonide .5 mg/g Ointment NDC 45802-423-35
- pseudoephedrine hydrochloride Pseudoephedrine HCl 30 mg Tablet, Film Coated NDC 45802-432-62
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ciclopirox Olamine Topical Suspension USP, 1.0% 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; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur .
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gently massage Ciclopirox Olamine Topical Suspension USP, 1.0% into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus 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 Topical Suspension USP, 1.0% the diagnosis should be redetermined.
Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
⛔ Contraindications ▾
CONTRAINDICATIONS Ciclopirox Olamine Topical Suspension USP, 1.0% is contraindicated in individuals who have shown hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS General - Ciclopirox Olamine Topical Suspension USP, 1.0% is not for ophthalmic use. Keep out of reach of children.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In the controlled clinical trial with 89 patients using ciclopirox olamine topical suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox olamine topical suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox olamine topical suspension. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Olamine Topical Suspension USP, 1.0% 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 Al 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 radiolabeled 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.
Autoradiographic studies with human cadaver 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. In vitro penetration studies in frozen or fresh excised human cadaver and pig skin indicated that the penetration of ciclopirox olamine topical suspension, 1.0% is equivalent to that of ciclopirox olamine cream 1.0%. Therapeutic equivalence of cream and suspension formulations was also indicated by studies of experimentally induced guinea pig and human trichophytosis.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ciclopirox Olamine Topical Suspension USP, 1.0% is available as follows: 30 mL bottle (NDC 45802- 400 -49) 60 mL bottle (NDC 45802- 400 -46) Bottle space provided to allow for vigorous shaking before each use.
📦 Storage and Handling ▾
Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Ciclopirox Olamine Topical Suspension USP, 1.0% is for topical use. Each gram of Ciclopirox Olamine Topical Suspension USP, 1.0% contains 10 mg of ciclopirox olamine equivalent to 7.70 mg of ciclopirox in a water miscible suspension base consisting of benzyl alcohol NF, cetyl alcohol NF, lactic acid USP, light mineral oil NF, myristyl alcohol NF, octyldodecanol NF, polysorbate 60 NF, purified water USP, sorbitan monostearate NF, and stearyl alcohol NF. Ciclopirox Olamine Topical Suspension USP, 1.0% 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. Ciclopirox Olamine Topical Suspension USP, 1.0% has a pH of 7.
The chemical structure is: Structural Formula
💬 Information for Patients ▾
Information for Patients - The patient should be told to: 1. Use the medication for the full treatment time even though signs/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, oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings.
⚠️ Precautions ▾
PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Olamine Topical Suspension USP, 1.0%, treatment should be discontinued and appropriate therapy instituted. Information for Patients - The patient should be told to: 1. Use the medication for the full treatment time even though signs/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, oozing) indicative of possible sensitization. 3.
Avoid the use of occlusive wrappings or dressings. 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 celIs) (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). Pregnancy Teratogenic Effects There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Olamine Topical Suspension USP, 1.0% 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).
Nursing Mothers - It is not known whether this drug is excreted in human milk. Caution should be exercised when Ciclopirox Olamine Topical Suspension USP, 1.0% is administered to a nursing woman. Pediatric Use - Safety and effectiveness in pediatric patients below the age of 10 years have not been established.
🍼 Nursing Mothers ▾
Nursing Mothers - It is not known whether this drug is excreted in human milk. Caution should be exercised when Ciclopirox Olamine Topical Suspension USP, 1.0% 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 celIs) (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 - Carton NDC 45802-400-49 Rx Only Ciclopirox Olamine Topical Suspension USP, 1.0% For Topical Use Only. Not for use in eyes. Keep Out of Reach of Children. Shake well before use. 30 mL carton image