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: DIRECT RX
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: cd387929-5b72-e3c0-e053-2a95a90adb22
SPL ID: 2c290c08-d35f-21b4-e063-6394a90a73b9
Version: 4
Effective date: 2025-01-20
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:34:11

Harmonized routes table
Harmonized routes
ORAL, 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	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		DIRECT RX	openfda.manufacturer_name
ndc	package	72189-278-15	openfda.package_ndc
ndc	product	72189-278	openfda.product_ndc
ndc11	package	72189027815	derived:openfda.package_ndc
rxcui		543546	openfda.rxcui
spl id		2c290c08-d35f-21b4-e063-6394a90a73b9	id
spl set id		cd387929-5b72-e3c0-e053-2a95a90adb22	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

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.