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: PAI Holdings, LLC dba PAI Pharma
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 28b4e26e-206a-4e8a-abfe-774b780e91c3
SPL ID: 7d265612-edc5-42bc-8e58-bae7d7ab7918
Version: 9
Effective date: 2026-07-21
Source export date: 2026-10-12
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:46:39

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	203621	derived:openfda.application_number
application number		ANDA203621	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		PAI Holdings, LLC dba PAI Pharma	openfda.manufacturer_name
ndc	package	0121-0868-02	openfda.package_ndc
ndc	package	0121-0868-50	openfda.package_ndc
ndc	package	0121-0868-40	openfda.package_ndc
ndc	package	0121-0868-05	openfda.package_ndc
ndc	package	0121-0868-16	openfda.package_ndc
ndc	package	0121-0868-00	openfda.package_ndc
ndc	product	0121-0868	openfda.product_ndc
ndc11	package	00121086800	derived:openfda.package_ndc
ndc11	package	00121086850	derived:openfda.package_ndc
ndc11	package	00121086840	derived:openfda.package_ndc
ndc11	package	00121086816	derived:openfda.package_ndc
ndc11	package	00121086802	derived:openfda.package_ndc
ndc11	package	00121086805	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		7d265612-edc5-42bc-8e58-bae7d7ab7918	id
spl set id		28b4e26e-206a-4e8a-abfe-774b780e91c3	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 PAI Pharma at 1-800-845-8210 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.