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: NuCare Pharmaceuticals,Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0b4dfd5e-641e-40e9-e063-6294a90a3fda
SPL ID: 2ad1d4c2-cbc9-0304-e063-6394a90aae6e
Version: 2
Effective date: 2025-01-03
Source export date: 2026-10-27
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:04:51

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	214346	derived:openfda.application_number
application number		ANDA214346	openfda.application_number
brand name		NYSTATIN	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		NuCare Pharmaceuticals,Inc.	openfda.manufacturer_name
ndc	package	68071-3543-6	openfda.package_ndc
ndc	product	68071-3543	openfda.product_ndc
ndc11	package	68071354306	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		2ad1d4c2-cbc9-0304-e063-6394a90aae6e	id
spl set id		0b4dfd5e-641e-40e9-e063-6294a90a3fda	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 To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500 or www.fda.gov/medwatch. 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.