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 CREAM
Manufacturer: Cosette Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: ec1b52af-d38e-eba1-e63c-dba4341d3af2
SPL ID: ee0cb97f-1642-0dc0-e053-2995a90a8db3
Version: 7
Effective date: 2022-11-22
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:39:15

Harmonized routes table
Harmonized routes
TOPICAL

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	ANDA	061966	derived:openfda.application_number
application number		ANDA061966	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN CREAM	openfda.generic_name
manufacturer name		Cosette Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0713-0678-15	openfda.package_ndc
ndc	package	0713-0678-31	openfda.package_ndc
ndc	product	0713-0678	openfda.product_ndc
ndc11	package	00713067815	derived:openfda.package_ndc
ndc11	package	00713067831	derived:openfda.package_ndc
rxcui		543546	openfda.rxcui
spl id		ee0cb97f-1642-0dc0-e053-2995a90a8db3	id
spl set id		ec1b52af-d38e-eba1-e63c-dba4341d3af2	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 The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General . ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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.