warnings
WARNING Clotrimazole lozenges are 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
- Padagis US LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3f57ef51-8202-4d0b-95a8-d2df468b8d9a
- SPL ID
- c3d8e3ce-0429-4979-a91d-58dd19bbe996
- Version
- 6
- Effective date
- 2022-05-31
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:54:58
| Harmonized routes |
|---|
| ORAL |
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 | 076763 | derived:openfda.application_number |
| application number | ANDA076763 | openfda.application_number | |
| brand name | Clotrimazole | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Padagis US LLC | openfda.manufacturer_name | |
| ndc | package | 0574-0107-14 | openfda.package_ndc |
| ndc | package | 0574-0107-77 | openfda.package_ndc |
| ndc | package | 0574-0107-70 | openfda.package_ndc |
| ndc | product | 0574-0107 | openfda.product_ndc |
| ndc11 | package | 00574010770 | derived:openfda.package_ndc |
| ndc11 | package | 00574010777 | derived:openfda.package_ndc |
| ndc11 | package | 00574010714 | derived:openfda.package_ndc |
| rxcui | 309371 | openfda.rxcui | |
| spl id | c3d8e3ce-0429-4979-a91d-58dd19bbe996 | id | |
| spl set id | 3f57ef51-8202-4d0b-95a8-d2df468b8d9a | 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 lozenges; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See Precautions section). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.