Nystatin Cream

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 Cream
Generic name: NYSTATIN CREAM
Manufacturer: Crown Laboratories
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 5a2b6fee-1437-0c3a-e053-2991aa0a3443
SPL ID: 48342e66-405b-57be-e063-6394a90a276c
Version: 8
Effective date: 2026-01-12
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:12:36

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	207733	derived:openfda.application_number
application number		ANDA207733	openfda.application_number
brand name		Nystatin Cream	openfda.brand_name
generic name		NYSTATIN CREAM	openfda.generic_name
manufacturer name		Crown Laboratories	openfda.manufacturer_name
ndc	package	0316-0221-30	openfda.package_ndc
ndc	package	0316-0221-15	openfda.package_ndc
ndc	product	0316-0221	openfda.product_ndc
ndc11	package	00316022115	derived:openfda.package_ndc
ndc11	package	00316022130	derived:openfda.package_ndc
rxcui		543546	openfda.rxcui
spl id		48342e66-405b-57be-e063-6394a90a276c	id
spl set id		5a2b6fee-1437-0c3a-e053-2991aa0a3443	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 cream 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 .) To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/

Reported adverse events (FAERS/openFDA)#

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