Nystatin

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
Generic name: NYSTATIN
Manufacturer: Bryant Ranch Prepack
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc
SPL ID: 6467595c-fcd2-4dd8-8521-a12d9980ce27
Version: 101
Effective date: 2026-07-09
Source export date: 2026-11-06
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/2cac198adf50bf0f7077ca012f418bbee1fb171f907f83d6a83048d9770d345b/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:11:18

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	212557	derived:openfda.application_number
application number		ANDA212557	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	72162-2576-3	openfda.package_ndc
ndc	package	72162-2576-2	openfda.package_ndc
ndc	product	72162-2576	openfda.product_ndc
ndc11	package	72162257603	derived:openfda.package_ndc
ndc11	package	72162257602	derived:openfda.package_ndc
rxcui		543546	openfda.rxcui
spl id		6467595c-fcd2-4dd8-8521-a12d9980ce27	id
spl set id		2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc	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 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. )

Reported adverse events (FAERS/openFDA)#

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