Prescription medicine
Ciclopirox First approved as Loprox
Ciclopirox (Loprox) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.169 per gram (Ciclopirox 0.77% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ciclopirox FDA label on DailyMed (effective July 10, 2026, Acella Pharmaceuticals, LLC); the NDA 18748 record on Drugs@FDA; every ciclopirox label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usage(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.
Forms and strengths
- 1 g/100ml
- 7.7 mg/g
- 7.7 mg/100ml
- 7.7 mg/ml
- 10 mg/.96ml
- 71.3 mg/ml
- 80 mg/ml
Solution; cream; gel; suspension; shampoo.
On the market
- Earliest approval on file
- December 30, 1982 Loprox, Eurofarma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first August 6, 2004; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 14 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.169 per gram Ciclopirox 0.77% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest December 9, 2025
- FAERS reports
- 2,937 through July 30, 2026
What is ciclopirox used for?
From the label: indications and usage(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. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. […]
Conditions named in the indications of ciclopirox's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Ciclopirox), Acella Pharmaceuticals, LLC, effective July 10, 2026 (SPL set a08137a9-331f-4615-9752-e2cb52b3d8fc), via openFDA; the full label on DailyMed
Is there a generic for ciclopirox (Loprox)?
The FDA approved the first generic ciclopirox on August 6, 2004. 27 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ciclopirox from 14 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1982 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ciclopirox (Loprox)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.169 per gram (Ciclopirox 0.77% cream), down 6% from $0.181 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ciclopirox 0.77% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ciclopirox 0.77% cream | Generic | $0.169 per gram | n/a | -6% |
| Ciclopirox 0.77% gel | Generic | $0.787 per gram | n/a | -26% |
| Ciclopirox 0.77% topical suspension | Generic | $0.765 per mL | n/a | +9% |
| Ciclopirox 1% shampoo | Generic | $0.211 per mL | n/a | -10% |
| Ciclopirox 8% solution | Generic | $1.15 per mL | n/a | -19% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ciclopirox been recalled?
The FDA's Enforcement Report lists 5 recalls naming ciclopirox since 2013: 0 Class I (the most serious), 1 Class II, 4 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 9, 2025 | Class II | SUN PHARMA /TARO | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint |
| February 13, 2019 | Class III | Perrigo New York, Inc. | Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. |
| January 19, 2018 | Class III | G & W Laboratories, Inc. | Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration. |
| March 20, 2017 | Class III | G & W Laboratories, Inc. | Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. |
| October 16, 2013 | Class III | Taro Pharmaceuticals U.S.A., Inc. | Subpotent. drug |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for ciclopirox?
The FDA Adverse Event Reporting System holds 2,937 reports that list ciclopirox among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 110 are coded as a death and 763 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ciclopirox?
18 other medicines are given the same way (topical) and in the same FDA class as ciclopirox or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tolnaftate | Fungal infections | none listed | $0.119 per gram 1% cream | No current entry |
| Clotrimazole | Fungal infections | 13 labelers | $0.133 per gram 1% topical cream | No current entry |
| Miconazole | Fungal infections | none listed | $0.120 per gram 2% topical cream | No current entry |
| Undecylenic acid | Fungal infections | none listed | n/a | No current entry |
| Ketoconazole | Fungal infections | 25 labelers | $0.249 per gram 2% cream | No current entry |
| Selenium sulfide | Fungal infections | 1 labeler | $0.0141 per mL 1% shampoo | No current entry |
| Nystatin and triamcinolone | Fungal infections | 18 labelers | $0.225 per gram Nystatin-triamcinolone cream | No current entry |
| Terbinafine | Fungal infections | 20 labelers | $0.353 per gram 1% cream | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ciclopirox compare with medicines for the same use?
5 side-by-side pages set ciclopirox beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Ciclopirox side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other