Nystatin Oral Suspension

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 Oral Suspension
Generic name: NYSTATIN
Manufacturer: Xttrium Laboratories, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 4a670371-d373-1ba6-e063-6394a90a13b6
SPL ID: 4a2ff89a-52fe-8bf9-e063-6394a90a7f1d
Version: 1
Effective date: 2026-02-06
Source export date: 2026-10-27
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/2026-10-27/29a1aba6a935d72bab5474118c2ccf25cb52dfe8488fe1593c734ea6c04e3722/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:45:06

Harmonized routes table
Harmonized routes
ORAL

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	062512	derived:openfda.application_number
application number		ANDA062512	openfda.application_number
brand name		Nystatin Oral Suspension	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		Xttrium Laboratories, Inc.	openfda.manufacturer_name
ndc	package	0116-4026-05	openfda.package_ndc
ndc	package	0116-4026-50	openfda.package_ndc
ndc	package	0116-4026-11	openfda.package_ndc
ndc	package	0116-4026-16	openfda.package_ndc
ndc	product	0116-4026	openfda.product_ndc
ndc11	package	00116402616	derived:openfda.package_ndc
ndc11	package	00116402605	derived:openfda.package_ndc
ndc11	package	00116402611	derived:openfda.package_ndc
ndc11	package	00116402650	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		4a2ff89a-52fe-8bf9-e063-6394a90a7f1d	id
spl set id		4a670371-d373-1ba6-e063-6394a90a13b6	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 Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ). Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 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.