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: Genus Lifesciences Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: b25cbae5-eaf5-4501-b013-02c778ca4a4e
SPL ID: 319a98e0-8009-47c9-9f40-9cd288c26e48
Version: 2
Effective date: 2026-05-07
Source export date: 2026-11-06
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/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:36:28

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	065148	derived:openfda.application_number
application number		ANDA065148	openfda.application_number
brand name		NYSTATIN	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Genus Lifesciences Inc.	openfda.manufacturer_name
ndc	package	64950-372-06	openfda.package_ndc
ndc	package	64950-372-47	openfda.package_ndc
ndc	product	64950-372	openfda.product_ndc
ndc11	package	64950037206	derived:openfda.package_ndc
ndc11	package	64950037247	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		319a98e0-8009-47c9-9f40-9cd288c26e48	id
spl set id		b25cbae5-eaf5-4501-b013-02c778ca4a4e	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 reported.

Reported adverse events (FAERS/openFDA)#

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