warnings
WARNINGS Econazole Nitrate Cream is not for ophthalmic use.
Econazole Nitrate
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
- Econazole Nitrate
- Generic name
- ECONAZOLE NITRATE
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 2bd2a48e-cbef-4b14-a02f-9aa693cc4b47
- SPL ID
- 2bd2a48e-cbef-4b14-a02f-9aa693cc4b47
- Version
- 1
- Effective date
- 2025-06-02
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:04:47
| 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 | 076479 | derived:openfda.application_number |
| application number | ANDA076479 | openfda.application_number | |
| brand name | Econazole Nitrate | openfda.brand_name | |
| generic name | ECONAZOLE NITRATE | openfda.generic_name | |
| manufacturer name | Preferred Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 68788-8884-3 | openfda.package_ndc |
| ndc | product | 68788-8884 | openfda.product_ndc |
| ndc11 | package | 68788888403 | derived:openfda.package_ndc |
| rxcui | 857366 | openfda.rxcui | |
| spl id | 2bd2a48e-cbef-4b14-a02f-9aa693cc4b47 | id | |
| spl set id | 2bd2a48e-cbef-4b14-a02f-9aa693cc4b47 | set_id | |
| unii | H438WYN10E | 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 During clinical trials, approximately 3% of patients treated with econazole nitrate cream, 1% reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.