Iris 60 Second APF

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: Iris 60 Second APF
Generic name: SODIUM FLUORIDE
Manufacturer: Benco Dental
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: d5658bf8-3a13-4d8b-b727-5f1575919571
SPL ID: d70c8143-4a70-9538-e053-2a95a90a059c
Version: 3
Effective date: 2022-02-02
Source export date: 2026-10-27
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/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:56:12

Harmonized routes table
Harmonized routes
DENTAL

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Iris 60 Second APF	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Benco Dental	openfda.manufacturer_name
ndc	package	66975-054-15	openfda.package_ndc
ndc	product	66975-054	openfda.product_ndc
ndc11	package	66975005415	derived:openfda.package_ndc
rxcui		245593	openfda.rxcui
spl id		d70c8143-4a70-9538-e053-2a95a90a059c	id
spl set id		d5658bf8-3a13-4d8b-b727-5f1575919571	set_id
unii		8ZYQ1474W7	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: • Keep out of reach of children. • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. • Read directions carefully before using.

Reported adverse events (FAERS/openFDA)#

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