Clotrimazole

The listing

NDC product code

0054-4146 (labeller 0054, product 4146)

Labeller

Hikma Pharmacuticals USA USA Inc.

Brand name

Clotrimazole

Generic name

Clotrimazole

Dosage form

Lozenge

Route

oral, topical

Marketing category

ANDA ANDA076387

Marketing start

29 July 2004

Listing expires

31 December 2026

Pharmacologic class

Azole Antifungal [EPC]

RxNorm concept

309371

Active ingredients

Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.

What the label claims

These are read from this product's own label, not assigned by us and not inferred from the ingredient.

Stated useOral thrush

Drug Facts, as filed

Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.

Uses

Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION .)

Warnings

Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.

Directions

Clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible. For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

Label version 14, effective 30 July 2021. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.

Packages

The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.

Identical on the active ingredient

2 other listings state exactly the same active ingredient at exactly the same strength in the same dosage form, across 2 different labellers. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.

Sources for this page

• FDA National Drug Code Directory entry for 0054-4146
• DailyMed label, set id 0bc4b876-ddee-4f03-b44f-544348739a26
• How Lozenges builds these pages