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: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: e87b8480-987d-4f82-87bf-cf831d6984a1
SPL ID: d5c4ffad-b502-4226-9ff2-8603aac88dba
Version: 11
Effective date: 2025-06-23
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:10:01

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	062474	derived:openfda.application_number
application number		ANDA062474	openfda.application_number
brand name		nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	openfda.manufacturer_name
ndc	package	23155-051-01	openfda.package_ndc
ndc	product	23155-051	openfda.product_ndc
ndc11	package	23155005101	derived:openfda.package_ndc
rxcui		312059	openfda.rxcui
spl id		d5c4ffad-b502-4226-9ff2-8603aac88dba	id
spl set id		e87b8480-987d-4f82-87bf-cf831d6984a1	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 nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) 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.