warnings
WARNINGS Naftifine Hydrochloride Cream USP, 1% is for topical use only and not for ophthalmic use.
Naftifine Hydrochloride
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
- Naftifine Hydrochloride
- Generic name
- NAFTIFINE HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- d50961c2-e97f-4583-91d6-7cafd25a8c3d
- SPL ID
- 39620da3-e660-e94f-e063-6294a90afd69
- Version
- 3
- Effective date
- 2025-07-07
- Source export date
- 2026-10-27
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:05:21
| 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 | 205975 | derived:openfda.application_number |
| application number | ANDA205975 | openfda.application_number | |
| brand name | Naftifine Hydrochloride | openfda.brand_name | |
| generic name | NAFTIFINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-1362-3 | openfda.package_ndc |
| ndc | package | 51672-1362-1 | openfda.package_ndc |
| ndc | package | 51672-1362-8 | openfda.package_ndc |
| ndc | package | 51672-1362-2 | openfda.package_ndc |
| ndc | product | 51672-1362 | openfda.product_ndc |
| ndc11 | package | 51672136208 | derived:openfda.package_ndc |
| ndc11 | package | 51672136202 | derived:openfda.package_ndc |
| ndc11 | package | 51672136203 | derived:openfda.package_ndc |
| ndc11 | package | 51672136201 | derived:openfda.package_ndc |
| rxcui | 896110 | openfda.rxcui | |
| spl id | 39620da3-e660-e94f-e063-6294a90afd69 | id | |
| spl set id | d50961c2-e97f-4583-91d6-7cafd25a8c3d | set_id | |
| unii | 25UR9N9041 | 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 with Naftifine Hydrochloride Cream USP, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.