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: 05cc72dd-8e05-bfb5-e063-6394a90a92f1
SPL ID: 5968f53d-ca46-0c6e-e063-6394a90af3b5
Version: 2
Effective date: 2026-08-19
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:08:18

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		NuCare Pharmaceuticals,Inc.	openfda.manufacturer_name
ndc	package	68071-3508-9	openfda.package_ndc
ndc	product	68071-3508	openfda.product_ndc
ndc11	package	68071350809	derived:openfda.package_ndc
rxcui		312059	openfda.rxcui
spl id		5968f53d-ca46-0c6e-e063-6394a90af3b5	id
spl set id		05cc72dd-8e05-bfb5-e063-6394a90a92f1	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.