Nystop

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: Nystop
Generic name: NYSTATIN
Manufacturer: Padagis US LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f
SPL ID: d0aa24d2-89e9-4067-80f7-97a14ac1c21f
Version: 11
Effective date: 2024-10-31
Source export date: 2026-11-06
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/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:37:20

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	064118	derived:openfda.application_number
application number		ANDA064118	openfda.application_number
brand name		Nystop	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Padagis US LLC	openfda.manufacturer_name
ndc	package	0574-2008-15	openfda.package_ndc
ndc	package	0574-2008-02	openfda.package_ndc
ndc	package	0574-2008-30	openfda.package_ndc
ndc	product	0574-2008	openfda.product_ndc
ndc11	package	00574200802	derived:openfda.package_ndc
ndc11	package	00574200815	derived:openfda.package_ndc
ndc11	package	00574200830	derived:openfda.package_ndc
rxcui		261178	openfda.rxcui
rxcui		646456	openfda.rxcui
spl id		d0aa24d2-89e9-4067-80f7-97a14ac1c21f	id
spl set id		e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f	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 topical preparations 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 .)

Reported adverse events (FAERS/openFDA)#

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