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: Torrent Pharmaceuticals Limited
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 4949dea7-d2b9-4e0d-974a-39408fa174ba
SPL ID: b5c975a5-4d7a-4177-b1e2-524bad92a5fb
Version: 8
Effective date: 2026-05-08
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:28:28

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	211838	derived:openfda.application_number
application number		ANDA211838	openfda.application_number
brand name		Nystatin	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Torrent Pharmaceuticals Limited	openfda.manufacturer_name
ndc	package	13668-534-01	openfda.package_ndc
ndc	package	13668-534-02	openfda.package_ndc
ndc	product	13668-534	openfda.product_ndc
ndc11	package	13668053402	derived:openfda.package_ndc
ndc11	package	13668053401	derived:openfda.package_ndc
rxcui		884308	openfda.rxcui
spl id		b5c975a5-4d7a-4177-b1e2-524bad92a5fb	id
spl set id		4949dea7-d2b9-4e0d-974a-39408fa174ba	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. )

Reported adverse events (FAERS/openFDA)#

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