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 OINTMENT
Manufacturer: Cosette Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 8f87de59-33f2-32af-ae17-78bf30fb424d
SPL ID: 0b479d47-d58c-1457-e063-6394a90a1256
Version: 9
Effective date: 2023-11-29
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:39:23

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	209114	derived:openfda.application_number
application number		ANDA209114	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN OINTMENT	openfda.generic_name
manufacturer name		Cosette Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0713-0686-31	openfda.package_ndc
ndc	package	0713-0686-15	openfda.package_ndc
ndc	product	0713-0686	openfda.product_ndc
ndc11	package	00713068631	derived:openfda.package_ndc
ndc11	package	00713068615	derived:openfda.package_ndc
rxcui		884308	openfda.rxcui
spl id		0b479d47-d58c-1457-e063-6394a90a1256	id
spl set id		8f87de59-33f2-32af-ae17-78bf30fb424d	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 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.