warnings
WARNINGS Oxiconazole nitrate cream, 1% is not for ophthalmic or intravaginal use.
Oxiconazole 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
- Oxiconazole Nitrate
- Generic name
- OXICONAZOLE NITRATE
- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- aa368d2b-a5d2-49dd-86e1-5693b68b46f4
- SPL ID
- 413f9391-fa2d-4449-b25d-fd11376f231e
- Version
- 5
- Effective date
- 2026-01-28
- Source export date
- 2026-09-28
- 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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:05
| 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 | NDA | 019828 | derived:openfda.application_number |
| application number | NDA019828 | openfda.application_number | |
| brand name | Oxiconazole Nitrate | openfda.brand_name | |
| generic name | OXICONAZOLE NITRATE | openfda.generic_name | |
| manufacturer name | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 0168-0358-30 | openfda.package_ndc |
| ndc | package | 0168-0358-60 | openfda.package_ndc |
| ndc | package | 0168-0358-90 | openfda.package_ndc |
| ndc | product | 0168-0358 | openfda.product_ndc |
| ndc11 | package | 00168035890 | derived:openfda.package_ndc |
| ndc11 | package | 00168035830 | derived:openfda.package_ndc |
| ndc11 | package | 00168035860 | derived:openfda.package_ndc |
| rxcui | 312139 | openfda.rxcui | |
| spl id | 413f9391-fa2d-4449-b25d-fd11376f231e | id | |
| spl set id | aa368d2b-a5d2-49dd-86e1-5693b68b46f4 | set_id | |
| unii | RQ8UL4C17S | 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, of 955 patients treated with oxiconazole nitrate cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.