PODOFILOX
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
- PODOFILOX
- Generic name
- PODOFILOX
- Manufacturer
- Padagis US LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 6af07697-5203-43e0-ba35-83683af851c3
- SPL ID
- e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da
- Version
- 9
- Effective date
- 2023-02-28
- Source export date
- 2026-09-28
- 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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:24:03
| 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 | 075600 | derived:openfda.application_number |
| application number | ANDA075600 | openfda.application_number | |
| brand name | PODOFILOX | openfda.brand_name | |
| generic name | PODOFILOX | openfda.generic_name | |
| manufacturer name | Padagis US LLC | openfda.manufacturer_name | |
| ndc | package | 0574-0611-05 | openfda.package_ndc |
| ndc | product | 0574-0611 | openfda.product_ndc |
| ndc11 | package | 00574061105 | derived:openfda.package_ndc |
| rxcui | 582926 | openfda.rxcui | |
| spl id | e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da | id | |
| spl set id | 6af07697-5203-43e0-ba35-83683af851c3 | set_id | |
| unii | L36H50F353 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Correct diagnosis of the lesions to be treated is essential. See the " Diagnosis " subsection of the INDICATIONS AND USAGE statement. Podofilox Topical Solution 0.5% is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patient should immediately flush the eye with copious quantities of water and seek medical advice.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In clinical trials, the following local adverse reactions were reported at some point during treatment. Adverse Experience Males Females Burning 64% 78% Pain 50% 72% Inflammation 71% 63% Erosion 67% 67% Itching 50% 65% Reports of burning and pain were more frequent and of greater severity in women than in men. Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.
adverse reactions table
<table width="100%"><col width="10%"/><col width="24%"/><col width="33%"/><col width="33%"/><thead><tr><th align="left" colspan="2" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Adverse Experience</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Males</content></th><th align="left" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Females</content></th></tr></thead><tbody><tr><td styleCode="Toprule " valign="top"/><td styleCode="Toprule " valign="top"><paragraph>Burning</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>64%</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>78%</paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph>Pain</paragraph></td><td valign="top"><paragraph>50%</paragraph></td><td valign="top"><paragraph>72%</paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph>Inflammation</paragraph></td><td valign="top"><paragraph>71%</paragraph></td><td valign="top"><paragraph>63%</paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph>Erosion</paragraph></td><td valign="top"><paragraph>67%</paragraph></td><td valign="top"><paragraph>67%</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"/><td styleCode="Botrule " valign="top"><paragraph>Itching</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>50%</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>65%</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.