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: Macleods Pharmaceuticals Limited
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: fe3db8b2-9de4-4f9e-b763-8536a1e4cea8
SPL ID: fe3db8b2-9de4-4f9e-b763-8536a1e4cea8
Version: 1
Effective date: 2021-01-29
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:54:10

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	213826	derived:openfda.application_number
application number		ANDA213826	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Macleods Pharmaceuticals Limited	openfda.manufacturer_name
ndc	package	33342-481-15	openfda.package_ndc
ndc	package	33342-481-30	openfda.package_ndc
ndc	product	33342-481	openfda.product_ndc
ndc11	package	33342048115	derived:openfda.package_ndc
ndc11	package	33342048130	derived:openfda.package_ndc
rxcui		884308	openfda.rxcui
spl id		fe3db8b2-9de4-4f9e-b763-8536a1e4cea8	id
spl set id		fe3db8b2-9de4-4f9e-b763-8536a1e4cea8	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 Ointment 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.) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).

Reported adverse events (FAERS/openFDA)#

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