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CICLOPIROX 1 g/100mL Shampoo — NDC 21922-105-52 (Billing 21922-0105-52)

by Encube Ethicals, Inc. · 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

This is a package of CICLOPIROX 1 g/100mL Shampoo from Encube Ethicals, Inc., marketed since Dec 2025 and currently FDA-listed; retail pharmacies pay about $0.2108 per mL (NADAC). It is this product's only package size.

NDC 21922-0105-52
🏷️ FDA NDC (as labeled) 21922-105-52 billing pads the product segment with a zero
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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 21922-105-52
Product NDC 21922-105
11-digit billing NDC 21922010552
NCPDP billing unit ML — per mL (volume)
RxCUI 250344
UNII 19W019ZDRJ
Application # ANDA209975
SPL Set ID cb456f2e-6645-4cc4-8e71-299c47ccb6b7
Mechanism of action Protein Synthesis Inhibitors
Physiologic effect Decreased DNA Replication; Decreased Protein Synthesis; Decreased RNA Replication
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-03
Route TOPICAL
Dosage form SHAMPOO
Substance CICLOPIROX
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90150030004510
GCN Seq No 051825
GCN 19218
HICL code 016915
Ingredient (HICL) Ciclopirox
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 84:04.08.20
AHFS class Hydroxypyridones (Skin, Mucous Membrane)
FDB label name CICLOPIROX 1% SHAMPOO
FDB brand name Ciclopirox
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051825
  • GCN: 19218
  • GPI-14 (Medi-Span): 90150030004510
  • HICL (First Databank): 016915
  • AHFS class code: 84:04.08.20
  • RxCUI (RxNorm): 250344
Why two NDCs? The FDA registers this code as 21922-105-52 — 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 → 21922-0105-52. 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 Other antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use, Other antiinfectives and antiseptics
How it works Protein Synthesis Inhibitors
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 CICLOPIROX 1% SHAMPOO Ingredient Ciclopirox
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Ciclopirox Topical 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 mLPer package
Retail pharmacies payNADAC · weekly $0.211 $25.30 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.3695 $44.34 / 120 ml
Medicare drug plans payPart D · Q2 2026 $0.3424 $41.09 / 120 ml
NADAC price history (per mL) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Sep 2026 $0.264 $0.211
▼ Down 20% over the last 5 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 Marketing startMarketing endStatus
21922-0105-52 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE 2025-12-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciclopirox 10 mg/.96mL 00591-2159-90 Actavis 120 ml $0.211 AT Availability likely —
Ciclopirox 1 g/100mLthis 21922-0105-52 Encube 1 bottle $0.211 AT Availability likely —
Ciclopirox 1 g/100mL 45802-0401-09 Padagis 120 ml $0.211 AT Availability likely —
Ciclopirox 10 mg/.96mL 51672-1351-08 Sun 1 bottle $0.211 AT Availability likely —
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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII D6DH1DTN7E
    Disodium laureth sulfosuccinate is a synthetic surfactant and emulsifier derived from lauryl alcohol. It helps mix oil and water-based ingredients together and is commonly used in topical formulations to improve product texture and spreadability.
  • UNII D4D38LT1L5
    A synthetic ingredient made from lauryl alcohol and ethylene oxide. It works as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII ZZQ59TY3KG
    Sodium laureth-2 sulfate is a cleansing agent made from coconut oil. It helps medicines dissolve properly and can reduce foaming or improve how the product spreads on skin.
  • 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.

5 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

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA209975 (ANDA)
Labeler code21922
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio77 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 43 words ▾

1 INDICATIONS AND USAGE Ciclopirox shampoo, 1 % is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. Ciclopirox shampoo is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ( 1 )

⏱️ Dosage and Administration 136 words ▾

2 DOSAGE AND ADMINISTRATION Ciclopirox shampoo is not for ophthalmic, oral, or intravaginal use. Wet hair and apply approximately 1 teaspoon (5 mL) of ciclopirox shampoo to the scalp. Up to 2 teaspoons (10 ml) may be used for long hair.

Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes.

Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with ciclopirox shampoo, the diagnosis should be reviewed.

Apply approximately 1 teaspoon of ciciopirox shampoo to the scalp twice per week for 4 weeks. ( 2 ) For topical use only. Not for ophthalmic, oral, or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Ciclopirox is a shampoo containing 1 % ciclopirox. Each gram (equivalent to 0.96 mL) of ciclopirox shampoo contains 10 mg ciclopirox in a colorless and translucent shampoo base. Shampoo, 1%

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None

⚠️ Warnings and Cautions 85 words ▾

5 WARNINGS AND PRECAUTIONS If signs of irritation occur, discontinue use. ( 5.1 ) Avoid contact with eyes. ( 5.1 ) Hair discoloration has been reported with ciclopirox use. ( 5.1 )

5.1Local Effects If a reaction suggesting sensitivity or irritation occurs with the use of ciclopirox shampoo, treatment should be discontinued and appropriate therapy instituted. Contact of cicloplrox shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water. In patients with lighter hair color, hair discoloration has been reported.

⚠️ Warnings 53 words ▾

5.1Local Effects If a reaction suggesting sensitivity or irritation occurs with the use of ciclopirox shampoo, treatment should be discontinued and appropriate therapy instituted. Contact of cicloplrox shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water. In patients with lighter hair color, hair discoloration has been reported.

🤒 Adverse Reactions 181 words ▾

6 ADVERSE REACTIONS The most frequently reported adverse reactions are pruritus, burning, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151, and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1CLINICAL TRIALS EXPERIENCE Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In 626 subjects treated with ciclopirox shampoo twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1 % of subjects.

6.2POSTMARKETING EXPERIENCE The following adverse reactions have been identified during post approval use of ciclopirox shampoo: hair discoloration and abnormal hair texture, alopecia, irritation and rash. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1PREGNANCY Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox shampoo 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 13, 42, 54 and 26 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 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).

8.3NURSING 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 shampoo is administered to a nursing woman.

8.4PEDIATRIC USE No clinical trials have been conducted in subjects younger than 16 years.

8.5GERIATRIC USE In clinical trials, the safety and tolerability of ciclopirox shampoo in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with ciclopirox shampoo, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.

🤰 Pregnancy 175 words ▾

8.1PREGNANCY Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox shampoo 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 13, 42, 54 and 26 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 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).

🧒 Pediatric Use 15 words ▾

8.4PEDIATRIC USE No clinical trials have been conducted in subjects younger than 16 years.

🧓 Geriatric Use 105 words ▾

8.5GERIATRIC USE In clinical trials, the safety and tolerability of ciclopirox shampoo in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with ciclopirox shampoo, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 183 words ▾

12 CLINICAL PHARMACOLOGY

12.1MECHANISM OF ACTION Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox 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.

12.2PHARMACODYNAMICS The pharmacodynamics of clcloplrox shampoo are unknown.

12.3PHARMACOKINETICS In a study in patients with seborrheic dermatitis of the scalp, application of 5 mL ciclopirox shampoo, 1 % twice weekly for 4 weeks, with an exposure time of 3 minutes per application, resulted in detectable serum concentrations of ciclopirox in 6 out of 18 patients. The serum concentrations measured throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL to 13.2 ng/ml. Total urinary excretion of ciclopirox was less than 0.5% of the administered dose.

12.4MICROBIOLOGY Ciclopirox is fungicidal in vitro against Malassezia furfur (Pityrosporum spp.), P. ovale, and P. orbiculare. The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

🧬 Mechanism of Action 58 words ▾

12.1MECHANISM OF ACTION Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox 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.

📦 How Supplied / Storage and Handling 43 words ▾

16 HOW SUPPLIED Ciclopirox shampoo, 1 % is colorless and translucent, and supplied in 120 mL plastic bottles (NOC 21922-105-52). Discard unused product after initial treatment duration. Store between 15°C and 30°C (59° F and 86° F). Keep out of reach of children.

📋 Description 89 words ▾

11 DESCRIPTION Ciclopirox shampoo 1 % contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 ml) of ciclopirox shampoo contains 10 mg ciclopirox m a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate. Ciclopirox shampoo is a colorless, translucent solution.

The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27. The GAS Registry Number is [29342-05-0]. The chemical structure is: structure

💬 Information for Patients 138 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). The patient should be instructed to: Use cicloplrox shampoo as directed by the physician. Avoid contact with the eyes.

If contact occurs, rinse thoroughly with water. Ciclopirox shampoo is for external use on the scalp only. Do not swallow.

Use ciclopirox shampoo for seborrheic dermatitis for the full treatment time even though symptoms may have improved. Notify the physician if there is no improvement after 4 weeks. Inform the physician if the area of application shows signs of increased initation (redness, itching, burning, blistering, swelling, or oozing).

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No.

C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Panda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC27713 USA Revision: 05/2025

🍼 Nursing Mothers 36 words ▾

8.3NURSING 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 shampoo is administered to a nursing woman.

🧬 Pharmacokinetics 81 words ▾

12.3PHARMACOKINETICS In a study in patients with seborrheic dermatitis of the scalp, application of 5 mL ciclopirox shampoo, 1 % twice weekly for 4 weeks, with an exposure time of 3 minutes per application, resulted in detectable serum concentrations of ciclopirox in 6 out of 18 patients. The serum concentrations measured throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL to 13.2 ng/ml. Total urinary excretion of ciclopirox was less than 0.5% of the administered dose.

🧬 Pharmacodynamics 9 words ▾

12.2PHARMACODYNAMICS The pharmacodynamics of clcloplrox shampoo are unknown.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES In two randomized, double-blind clinical trials, subjects 16 years and older with seborrheic dermatitis of the scalp applied ciclopirox shampoo or its vehicle twice weekly for 4 weeks. Subjects who were immune- compromised, those with psoriasis or atopic dermatitis, women of childbearing potential not using adequate contraception, and pregnant or lactating women were excluded from the clinical trials. An evaluation of the overall status of the seborrheic dermatitis, the presence and severity of erythema or inflammation, and scaling, was made at Week 4, using a scale of 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = pronounced, and 5 = severe.

Effective treatment was defined as achieving a score of o (or a score of 1 If the baseline score was ≥ 3) simultaneously for status of the seborrheic dermatitis, erythema or inflammation, and scaling at Week 4. Ciclopirox shampoo was shown to be statistically significantly more effective than vehicle in both trials. Efficacy results for the two trials are presented in Table 1 below.

Table 1. Effective Treatment Rates at Week 4 in Trials 1 and 2 Clcloplrox Shampoo Vehicle Study 1 220/380 (58%) 60/192 (31%) Study 2 65/250 (26%) 32/249 (1 3%) Efficacy for African American subjects was not demonstrated, although only 53African American subjects were enrolled in the two pivotal trials.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1CARCINOGENESIS & 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 mglm2/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 Fe3+, 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 5,000 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 1.3 times the maximum recommended human dose based on body surface area comparisons).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1CARCINOGENESIS & 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 mglm2/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 Fe3+, 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 5,000 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 1.3 times the maximum recommended human dose based on body surface area comparisons).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Ciclopirox (sye" kloe pir' ox) Shampoo Important: For use on the scalp only. Do not get ciclopirox shampoo in your eyes, mouth, or vagina. What is ciclopirox shampoo?

Ciclopirox shampoo is a prescription medicine used on the scalp to treat adults with a skin condition called seborrheic dermatitis. It is not known if ciclopirox shampoo is safe and effective in children under 16 years of age. What should I tell my doctor before using ciclopirox shampoo?

Before using ciclopirox shampoo, tell your doctor if you: have any other medical conditions are pregnant or plan to become pregnant. It is not known if ciclopirox shampoo will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ciclopirox shampoo passes into your breast milk. are taking prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use ciclopirox shampoo?

Use ciclopirox shampoo exactly as your doctor tells you to use it. Wash your hair using ciclopirox shampoo 2 times each week for 4 weeks. There should be at least 3 days between each time you use ciclopirox shampoo.

Use ciclopirox shampoo for 4 weeks even if your skin condition improves. Tell your doctor if your scalp condition is not getting better after you have used ciclopirox shampoo for 4 weeks. Do not swallow ciclopirox shampoo.

Avoid getting ciclopirox shampoo in your eyes. If ciclopirox shampoo gets into your eyes, rinse them well with water. How should I apply ciclopirox shampoo?

Wet your hair and apply approximately 1 teaspoon of ciclopirox shampoo to your scalp. You may use up to 2 teaspoons of ciclopirox shampoo if you have long hair. Lather and leave ciclopirox shampoo on your hair and scalp for 3 minutes.

You may use a timer. After 3 minutes have passed, rinse your hair and scalp. What are the possible side effects of ciclopirox shampoo?

The most common side effects of ciclopirox shampoo include: itching, burning, and redness of the scalp. Tell your doctor if you get any of these symptoms and they become worse or do not go away, or if you get blistering, swelling, or oozing in your scalp. These are not all the possible side effects of ciclopirox shampoo.

For more information, ask your doctor. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ciclopirox shampoo? Store ciclopirox shampoo at room temperature, between 59°F to 86°F (15°Cto30°C). Safely throw away any unused ciclopirox shampoo after you finish your treatment.

Keep ciclopirox shampoo and all medicines out of the reach of children. General information about ciclopirox shampoo Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ciclopirox shampoo for a condition for which it was not prescribed.

Do not give ciclopirox shampoo to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about ciclopirox shampoo that is written for health professionals.

For more information about ciclopirox shampoo, call 1-833-285-4151. What are the ingredients in ciclopirox shampoo? Active ingredient: ciclopirox Inactive ingredients: disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate.

This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: Encube Ethicals Pvt.

Ltd. PlotNo. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Panda, Goa - 403 404, India.

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713 USA Revision: 05/2025

📄 Package Label / Principal Display Panel 33 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 21922- 105 -52 Ciclopirox Shampoo 1% For Topical Use Only Not for Ophthalmic, Oral or Intravaginal Use. Keep Out of Reach of Children RX only 120 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 2026 – Q1 2026 · 1 quarter 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
31
Units reimbursed last 4 qtrs
3.7K
Gross reimbursed last 4 qtrs
$1.4K
Avg / prescription
$44.33
Avg / unit
$0.3695
Latest quarter Q1 2026
31Rx
Medicaid pays / mL
$0.3695
gross reimbursed
vs
NADAC / mL
$0.2108
acquisition cost
=
Spread
+$0.1587
+75% 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 · 31 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: 3,720 units · 19.0 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
19.019.0
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 19.0 /100k
💵 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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ciclopirox — the program that covers self-administered drugs. 9 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 Ciclopirox. 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
$6.35M
Claims incl. refills
257.1K
Beneficiaries
197.4K
Spend / beneficiary
$32.18
Spend / claim
$24.71
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.

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 Ciclopirox — the ingredient across all brands.

Top reported reactions

Fatigue181
Pain170
Diarrhoea147
Pruritus135
Rash135
Headache133
Dyspnoea115

Age at onset

Neonate1
Child3
Adolescent4
Adult390
Elderly286

Reporter sex

2,937 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization763
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 291 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.
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.