warnings
WARNINGS CLOTRIMAZOLE TOPICAL SOLUTION is not for ophthalmic use.
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
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3e2041a0-8bef-4be4-b2b1-556446c4a778
- SPL ID
- 390848b9-e9c6-c3c4-e063-6294a90a5b26
- Version
- 4
- Effective date
- 2025-07-03
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:25:54
| Harmonized routes |
|---|
| 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 | 074580 | derived:openfda.application_number |
| application number | ANDA074580 | openfda.application_number | |
| brand name | Clotrimazole | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-1260-3 | openfda.package_ndc |
| ndc | product | 51672-1260 | openfda.product_ndc |
| ndc11 | package | 51672126003 | derived:openfda.package_ndc |
| rxcui | 309370 | openfda.rxcui | |
| spl id | 390848b9-e9c6-c3c4-e063-6294a90a5b26 | id | |
| spl set id | 3e2041a0-8bef-4be4-b2b1-556446c4a778 | 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 The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.