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: Chartwell RX, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 9954118e-abe6-4388-98c9-4473d39b2e28
SPL ID: 4c47b825-6b93-307f-e063-6394a90a2b7d
Version: 7
Effective date: 2026-03-05
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 02:13:24

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	NDA	050299	derived:openfda.application_number
application number		NDA050299	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Chartwell RX, LLC	openfda.manufacturer_name
ndc	package	62135-813-46	openfda.package_ndc
ndc	package	62135-813-47	openfda.package_ndc
ndc	product	62135-813	openfda.product_ndc
ndc11	package	62135081346	derived:openfda.package_ndc
ndc11	package	62135081347	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		4c47b825-6b93-307f-e063-6394a90a2b7d	id
spl set id		9954118e-abe6-4388-98c9-4473d39b2e28	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 Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

Reported adverse events (FAERS/openFDA)#

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