Nystatin Topical Powder

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)

Brand name: Nystatin Topical Powder
Generic name: NYSTATIN TOPICAL POWDER
Manufacturer: Epic Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: fb2a480e-0bb1-445e-bbb6-701dea6dc631
SPL ID: 8723c280-f501-46c5-8be5-8a3e9cbd28b9
Version: 1
Effective date: 2023-08-10
Source export date: 2026-10-22
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-22/14398cbe7e22245154b804e51e14ec487486e2bb68b514fde0d7c34660e837f0/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 00:32:00

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	210532	derived:openfda.application_number
application number		ANDA210532	openfda.application_number
brand name		Nystatin Topical Powder	openfda.brand_name
generic name		NYSTATIN TOPICAL POWDER	openfda.generic_name
manufacturer name		Epic Pharma, LLC	openfda.manufacturer_name
ndc	package	42806-185-60	openfda.package_ndc
ndc	package	42806-185-15	openfda.package_ndc
ndc	package	42806-185-30	openfda.package_ndc
ndc	product	42806-185	openfda.product_ndc
ndc11	package	42806018560	derived:openfda.package_ndc
ndc11	package	42806018515	derived:openfda.package_ndc
ndc11	package	42806018530	derived:openfda.package_ndc
rxcui		646456	openfda.rxcui
spl id		8723c280-f501-46c5-8be5-8a3e9cbd28b9	id
spl set id		fb2a480e-0bb1-445e-bbb6-701dea6dc631	set_id
unii		BDF1O1C72E	openfda.unii

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 topical powder 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 .)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.