Quick answers
- What is Ciclopirox used for?
- The FDA-approved label (Ciclopirox, Acella Pharmaceuticals, LLC, July 10, 2026) says: “(To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.) Ciclopirox topical solution, USP 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ciclopirox have a boxed warning?
- No. None of the 38 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ciclopirox?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ciclopirox been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started February 13, 2019 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Ciclopirox?
- 13 companies list prescription products of Ciclopirox in the FDA NDC Directory, including Bryant Ranch Prepack, Padagis Israel Pharmaceuticals Ltd and Sun Pharmaceutical Industries, Inc..
What Ciclopirox is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
(To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.) Ciclopirox topical solution, USP 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. …
— FDA label: Ciclopirox, Acella Pharmaceuticals, LLC, effective July 10, 2026. Read the full label on DailyMed →
The FDA has 38 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 38 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Cream · Gel · Suspension · Shampoo |
|---|---|
| Route | Topical |
| Prescription products | 39 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ciclopirox 0.77% gel | Generic | $0.8293–$0.8597 per gram 6 packages, lowest to highest |
| ciclopirox 1% shampoo | Generic | $0.1931 per mL |
| ciclopirox 10 mg/0.96 mL shampoo | Generic | $0.1931 per mL |
| ciclopirox 80 mg/mL solution | Generic | $1.17 per mL |
| ciclopirox olamine 0.77% cream | Generic | $0.0998–$0.2285 per gram 12 packages, lowest to highest |
| ciclopirox olamine 7.7 mg/mL suspension | Generic | $0.7054–$0.8111 per mL 2 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack20 products
- Padagis Israel Pharmaceuticals Ltd4 products
- Sun Pharmaceutical Industries, Inc.2 products
- Encube Ethicals, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Padagis US LLC1 product
- Acella Pharmaceuticals, LLC1 product
- A-S Medication Solutions1 product
- Chartwell RX, LLC1 product
- Actavis Pharma, Inc.1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Cosette Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (15)
- ANDA076790Sun Pharma Canada · April 12, 2005
- ANDA077364Padagis Israel · March 3, 2006
- ANDA077676Padagis Israel · December 15, 2006
- ANDA077623Padagis Us · September 18, 2007
- ANDA077687Encube · September 18, 2007
- ANDA078046Chartwell Rx · September 18, 2007
- ANDA078172Acella · September 18, 2007
- ANDA078266Padagis Us · January 7, 2009
- ANDA090273Glenmark Pharms · November 10, 2009
- ANDA090490Actavis Mid Atlantic · November 24, 2009
- ANDA078594Padagis Us · February 16, 2010
- ANDA078463Cosette Pharms Nc · December 20, 2010
- ANDA090269Sun Pharma Canada · February 23, 2011
- ANDA091595Glenmark Pharms · February 29, 2012
- ANDA209975Encube · April 5, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 13, 2019 · Class III · Terminated · D-0512-2019
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09 — Perrigo New York, Inc.
-
January 19, 2018 · Class III · Terminated · D-0250-2018
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfiel — G & W Laboratories, Inc.
-
March 20, 2017 · Class III · Terminated · D-0636-2017
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld — G & W Laboratories, Inc.
-
October 16, 2013 · Class III · Terminated · D-347-2014
Subpotent. drug
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8. — Taro Pharmaceuticals U.S.A., Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ciclopirox, Acella Pharmaceuticals, LLC, effective July 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →