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: Padagis Israel Pharmaceuticals Ltd
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 6c091c66-2e4d-4412-b7bf-35315dc8152f
SPL ID: d0882d4c-19ef-45d3-99c2-2697b1d213d4
Version: 10
Effective date: 2025-01-23
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:55

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	062472	derived:openfda.application_number
application number		ANDA062472	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Padagis Israel Pharmaceuticals Ltd	openfda.manufacturer_name
ndc	package	45802-048-11	openfda.package_ndc
ndc	package	45802-048-35	openfda.package_ndc
ndc	product	45802-048	openfda.product_ndc
ndc11	package	45802004835	derived:openfda.package_ndc
ndc11	package	45802004811	derived:openfda.package_ndc
rxcui		884308	openfda.rxcui
spl id		d0882d4c-19ef-45d3-99c2-2697b1d213d4	id
spl set id		6c091c66-2e4d-4412-b7bf-35315dc8152f	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 Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

Reported adverse events (FAERS/openFDA)#

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