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: ATLANTIC BIOLOGICALS CORP.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 5c08148f-83e5-4f14-b0d3-af8d2c26062e
SPL ID: 484acdef-5f40-bd3e-e063-6394a90aebe2
Version: 3
Effective date: 2026-01-13
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 05:15:49

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	214346	derived:openfda.application_number
application number		ANDA214346	openfda.application_number
brand name		NYSTATIN	openfda.brand_name
generic name		NYSTATIN	openfda.generic_name
manufacturer name		ATLANTIC BIOLOGICALS CORP.	openfda.manufacturer_name
ndc	package	17856-0508-7	openfda.package_ndc
ndc	package	17856-0508-3	openfda.package_ndc
ndc	package	17856-0508-1	openfda.package_ndc
ndc	package	17856-0508-5	openfda.package_ndc
ndc	product	17856-0508	openfda.product_ndc
ndc11	package	17856050807	derived:openfda.package_ndc
ndc11	package	17856050805	derived:openfda.package_ndc
ndc11	package	17856050803	derived:openfda.package_ndc
ndc11	package	17856050801	derived:openfda.package_ndc
rxcui		312055	openfda.rxcui
spl id		484acdef-5f40-bd3e-e063-6394a90aebe2	id
spl set id		5c08148f-83e5-4f14-b0d3-af8d2c26062e	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 To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

Reported adverse events (FAERS/openFDA)#

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