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
- Redpharm Drug
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 53cafc9f-7761-83a9-e063-6294a90a3437
- SPL ID
- 53cb3b8e-e8d2-fffc-e063-6294a90ac814
- Version
- 1
- Effective date
- 2026-06-09
- Source export date
- 2026-10-27
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/29a1aba6a935d72bab5474118c2ccf25cb52dfe8488fe1593c734ea6c04e3722/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 19:45:21
| 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 | 090219 | derived:openfda.application_number |
| application number | ANDA090219 | openfda.application_number | |
| brand name | Clotrimazole | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Redpharm Drug | openfda.manufacturer_name | |
| ndc | package | 67296-2252-3 | openfda.package_ndc |
| ndc | product | 67296-2252 | openfda.product_ndc |
| ndc11 | package | 67296225203 | derived:openfda.package_ndc |
| rxcui | 309367 | openfda.rxcui | |
| spl id | 53cb3b8e-e8d2-fffc-e063-6294a90ac814 | id | |
| spl set id | 53cafc9f-7761-83a9-e063-6294a90a3437 | set_id | |
| unii | G07GZ97H65 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Clotrimazole cream is not for ophthalmic use.
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 this product: erythema, stinging, blistering, peeling, edema, pruritis, urticaria, burning, and general irritation of the skin.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.