Mycostatin

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: Mycostatin
Generic name: NYSTATIN
Manufacturer: Direct_Rx
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: f1857ac0-806c-4a7e-e053-2995a90abbc0
SPL ID: 4d3a9fbe-9f7f-e1a0-e063-6294a90a7857
Version: 3
Effective date: 2026-03-17
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:03

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	062225	derived:openfda.application_number
application number		ANDA062225	openfda.application_number
brand name		Mycostatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Direct_Rx	openfda.manufacturer_name
ndc	package	72189-408-15	openfda.package_ndc
ndc	product	72189-408	openfda.product_ndc
ndc11	package	72189040815	derived:openfda.package_ndc
spl id		4d3a9fbe-9f7f-e1a0-e063-6294a90a7857	id
spl set id		f1857ac0-806c-4a7e-e053-2995a90abbc0	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 USP 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.