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: Sun Pharmaceutical Industries, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 4d845b3f-ca26-4c47-b424-b6d783cc10e5
SPL ID: 3908cf94-b2b6-30a4-e063-6394a90add43
Version: 6
Effective date: 2025-07-03
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 19:59:54

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	064022	derived:openfda.application_number
application number		ANDA064022	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Sun Pharmaceutical Industries, Inc.	openfda.manufacturer_name
ndc	package	51672-1289-2	openfda.package_ndc
ndc	package	51672-1289-1	openfda.package_ndc
ndc	product	51672-1289	openfda.product_ndc
ndc11	package	51672128901	derived:openfda.package_ndc
ndc11	package	51672128902	derived:openfda.package_ndc
rxcui		543546	openfda.rxcui
spl id		3908cf94-b2b6-30a4-e063-6394a90add43	id
spl set id		4d845b3f-ca26-4c47-b424-b6d783cc10e5	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 .)

Reported adverse events (FAERS/openFDA)#

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