warnings
WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.
Clotrimazole
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Clotrimazole
- Generic name
- CLOTRIMAZOLE
- Manufacturer
- Hikma Pharmacuticals USA USA Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0bc4b876-ddee-4f03-b44f-544348739a26
- SPL ID
- 3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963
- Version
- 14
- Effective date
- 2021-07-30
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:32:12
| Harmonized routes |
|---|
| ORAL, TOPICAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 076387 | derived:openfda.application_number |
| application number | ANDA076387 | openfda.application_number | |
| brand name | Clotrimazole | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Hikma Pharmacuticals USA USA Inc. | openfda.manufacturer_name | |
| ndc | package | 0054-8146-22 | openfda.package_ndc |
| ndc | package | 0054-4146-22 | openfda.package_ndc |
| ndc | package | 0054-4146-23 | openfda.package_ndc |
| ndc | product | 0054-4146 | openfda.product_ndc |
| ndc | product | 0054-8146 | openfda.product_ndc |
| ndc11 | package | 00054414622 | derived:openfda.package_ndc |
| ndc11 | package | 00054414623 | derived:openfda.package_ndc |
| ndc11 | package | 00054814622 | derived:openfda.package_ndc |
| rxcui | 309371 | openfda.rxcui | |
| spl id | 3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963 | id | |
| spl set id | 0bc4b876-ddee-4f03-b44f-544348739a26 | set_id | |
| unii | G07GZ97H65 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS ). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.