KLAYESTA

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: KLAYESTA
Generic name: NYSTATIN TOPICAL POWDER
Manufacturer: Epic Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0df13b1e-0e07-4123-a83a-1d7afb56170f
SPL ID: d8220de7-25d0-46ba-b5a0-8f2f35bd5323
Version: 3
Effective date: 2025-12-17
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:51

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	210532	derived:openfda.application_number
application number		ANDA210532	openfda.application_number
brand name		KLAYESTA	openfda.brand_name
generic name		NYSTATIN TOPICAL POWDER	openfda.generic_name
manufacturer name		Epic Pharma, LLC	openfda.manufacturer_name
ndc	package	42806-186-60	openfda.package_ndc
ndc	package	42806-186-15	openfda.package_ndc
ndc	package	42806-186-30	openfda.package_ndc
ndc	product	42806-186	openfda.product_ndc
ndc11	package	42806018660	derived:openfda.package_ndc
ndc11	package	42806018615	derived:openfda.package_ndc
ndc11	package	42806018630	derived:openfda.package_ndc
rxcui		646456	openfda.rxcui
spl id		d8220de7-25d0-46ba-b5a0-8f2f35bd5323	id
spl set id		0df13b1e-0e07-4123-a83a-1d7afb56170f	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 KLAYESTA 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.