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: 50737729-a4a4-e747-e063-6394a90adcc5
SPL ID: 50738a43-7297-270c-e063-6294a90af2cc
Version: 1
Effective date: 2026-06-30
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:02:43

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 · 14 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	81033-015-60	openfda.package_ndc
ndc	package	81033-015-16	openfda.package_ndc
ndc	product	81033-015	openfda.product_ndc
ndc11	package	81033001560	derived:openfda.package_ndc
ndc11	package	81033001516	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		50738a43-7297-270c-e063-6294a90af2cc	id
spl set id		50737729-a4a4-e747-e063-6394a90adcc5	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.