Home FDA labels 1ef3ba41-7fea-2f83-e063-6294a90a161e FDA label 1ef3ba41-7fea-2f83-e063-6294a90a161e 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 (canonical bytes are SHA-256 checked before publication)
SPL set ID f0e9f6e9-4d19-b22a-e053-2995a90a3913
SPL ID 1ef3ba41-7fea-2f83-e063-6294a90a161e
Version 4
Effective date 2024-08-05
Source export date 2026-08-17
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-17/2761da4658ad131439428ba873b36a73954aaa035ff81deb66240a9db091dbf8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run 20260818T065550Z
Imported at 2026-08-18 08:18:06 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General. ) To report SUSPECTED ADVERSE REACTIONS, contact A2A Integrated Pharmaceuticals, LLC at 1-800-380-6709 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/