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: Proficient Rx LP
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 04d795f3-aad7-4b79-8ebc-43c500afe39b
SPL ID: 98364393-50d2-4479-9048-8095cfa7a290
Version: 2
Effective date: 2021-08-01
Source export date: 2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:09:22

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	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		Proficient Rx LP	openfda.manufacturer_name
ndc	package	71205-575-90	openfda.package_ndc
ndc	package	71205-575-30	openfda.package_ndc
ndc	package	71205-575-60	openfda.package_ndc
ndc	product	71205-575	openfda.product_ndc
ndc11	package	71205057530	derived:openfda.package_ndc
ndc11	package	71205057590	derived:openfda.package_ndc
ndc11	package	71205057560	derived:openfda.package_ndc
rxcui		312059	openfda.rxcui
spl id		98364393-50d2-4479-9048-8095cfa7a290	id
spl set id		04d795f3-aad7-4b79-8ebc-43c500afe39b	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.