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
- Rising Pharma Holdings, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 980736aa-751a-4642-ab85-a309435fd02f
- SPL ID
- de2c09da-6280-4873-859a-80e779643612
- Version
- 2
- Effective date
- 2025-03-27
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:18:28
| 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 | 215641 | derived:openfda.application_number |
| application number | ANDA215641 | openfda.application_number | |
| brand name | CLOTRIMAZOLE | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Rising Pharma Holdings, Inc. | openfda.manufacturer_name | |
| ndc | package | 16571-686-14 | openfda.package_ndc |
| ndc | package | 16571-686-07 | openfda.package_ndc |
| ndc | product | 16571-686 | openfda.product_ndc |
| ndc11 | package | 16571068607 | derived:openfda.package_ndc |
| ndc11 | package | 16571068614 | derived:openfda.package_ndc |
| rxcui | 309371 | openfda.rxcui | |
| spl id | de2c09da-6280-4873-859a-80e779643612 | id | |
| spl set id | 980736aa-751a-4642-ab85-a309435fd02f | 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 ). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.