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: A-S Medication Solutions
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9
SPL ID: 517d9b5e-2840-4db0-a042-c990b7b5d768
Version: 3
Effective date: 2026-07-24
Source export date: 2026-11-06
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/2026-11-06/3b52cde3709f43d454872fcaffdb78395b270bc65272c06ef1005cc77c998864/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:00:14

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 · 12 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	openfda.generic_name
manufacturer name		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-3799-0	openfda.package_ndc
ndc	product	50090-3799	openfda.product_ndc
ndc11	package	50090379900	derived:openfda.package_ndc
rxcui		543546	openfda.rxcui
spl id		517d9b5e-2840-4db0-a042-c990b7b5d768	id
spl set id		98bd8ccb-0c68-47b9-bcb4-c5d8217868d9	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.