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: Kesin Pharma Corporation
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 43817169-bbe8-58ee-e063-6294a90a1250
SPL ID: 45b08d8c-c755-d45b-e063-6394a90aa4c8
Version: 2
Effective date: 2025-12-11
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 05:57:16

Harmonized routes table
Harmonized routes
ORAL

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	062832	derived:openfda.application_number
application number		ANDA062832	openfda.application_number
brand name		NYSTATIN	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Kesin Pharma Corporation	openfda.manufacturer_name
ndc	package	81033-015-01	openfda.package_ndc
ndc	package	81033-015-54	openfda.package_ndc
ndc	package	81033-015-05	openfda.package_ndc
ndc	product	81033-015	openfda.product_ndc
ndc11	package	81033001505	derived:openfda.package_ndc
ndc11	package	81033001554	derived:openfda.package_ndc
ndc11	package	81033001501	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		45b08d8c-c755-d45b-e063-6394a90aa4c8	id
spl set id		43817169-bbe8-58ee-e063-6294a90a1250	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 is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ). Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic : Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

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