warnings
WARNINGS Oxiconazole nitrate cream 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
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 04477378-cccc-4db3-9e1b-5c1d6a00bd13
- SPL ID
- 38efa4f4-a3f2-fd03-e063-6394a90aac00
- Version
- 7
- Effective date
- 2025-07-02
- Source export date
- 2026-10-27
- 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/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:58:04
| 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 | 205076 | derived:openfda.application_number |
| application number | ANDA205076 | openfda.application_number | |
| brand name | Oxiconazole Nitrate | openfda.brand_name | |
| generic name | OXICONAZOLE NITRATE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-1359-2 | openfda.package_ndc |
| ndc | package | 51672-1359-3 | openfda.package_ndc |
| ndc | package | 51672-1359-1 | openfda.package_ndc |
| ndc | package | 51672-1359-8 | openfda.package_ndc |
| ndc | product | 51672-1359 | openfda.product_ndc |
| ndc11 | package | 51672135901 | derived:openfda.package_ndc |
| ndc11 | package | 51672135908 | derived:openfda.package_ndc |
| ndc11 | package | 51672135903 | derived:openfda.package_ndc |
| ndc11 | package | 51672135902 | derived:openfda.package_ndc |
| rxcui | 312139 | openfda.rxcui | |
| spl id | 38efa4f4-a3f2-fd03-e063-6394a90aac00 | id | |
| spl set id | 04477378-cccc-4db3-9e1b-5c1d6a00bd13 | 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). In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion , 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.