Quick answers
- What is Clotrimazole used for?
- The FDA-approved label (CLOTIC (clotrimazole) otic solution, Carwin Pharmaceutical Associates, LLC, March 3, 2026) says: “CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clotrimazole have a boxed warning?
- No. None of the 18 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clotrimazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clotrimazole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Clotrimazole?
- 17 companies list prescription products of Clotrimazole in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Aarna USA Inc and A-S Medication Solutions.
What Clotrimazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes. …
— FDA label: CLOTIC (clotrimazole) otic solution, Carwin Pharmaceutical Associates, LLC, effective March 3, 2026. Read the full label on DailyMed →
The FDA has 18 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.
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 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Cream · Lozenge · Spray · Liquid |
|---|---|
| Route | Topical · Oral · Auricular (otic) |
| Prescription products | 18 in the FDA NDC Directory |
| Brand names | Clotic (Clotrimazole) Otic Solution |
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 |
|---|---|---|
| clotrimazole 1% cream | Generic | $0.1328–$0.3431 per gram 7 packages, lowest to highest |
| clotrimazole 10 mg lozenge | Generic | $0.3039 per unit |
| clotrimazole 10 mg/mL solution | Generic | $0.4188–$2.74 per mL 5 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.
- Sun Pharmaceutical Industries, Inc.2 products
- Aarna USA Inc1 product
- A-S Medication Solutions1 product
- Novitium Pharma LLC1 product
- Carwin Pharmaceutical Associates, LLC1 product
- Rising Pharma Holdings, Inc.1 product
- ScieGen Pharmaceuticals, Inc.1 product
- Proficient Rx LP1 product
- TruPharma, LLC1 product
- Redpharm Drug1 product
- Padagis US LLC1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Hikma Pharmacuticals USA USA Inc.1 product
- Akron Pharma Inc.1 product
- Bryant Ranch Prepack1 product
- Preferred Pharmaceuticals Inc.1 product
- Allegis Holdings LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA217628 CLOTIC | Carwin Pharm Assoc | September 26, 2025 | — |
Generic approvals (9)
- ANDA072640Sun Pharma Canada · August 31, 1993
- ANDA074580Sun Pharma Canada · July 29, 1996
- ANDA076387Hikma · July 29, 2004
- ANDA076763Padagis Us · October 28, 2005
- ANDA090219Glenmark Pharms · August 3, 2010
- ANDA209815Novitium Pharma · February 15, 2019
- ANDA212281Tp Anda Holdings · July 25, 2019
- ANDA216569Sciegen Pharms · October 16, 2023
- ANDA215641Rising · February 29, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — CLOTIC (clotrimazole) otic solution, Carwin Pharmaceutical Associates, LLC, effective March 3, 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 →