Ionite 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: Ionite APF
Generic name: SODIUM FLUORIDE
Manufacturer: Dharma Research, inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
SPL ID: 373417c2-b73d-4928-978a-ffa2b4b38746
Version: 3
Effective date: 2020-11-16
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:36:58

Harmonized routes table
Harmonized routes
DENTAL, 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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Ionite APF	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Dharma Research, inc.	openfda.manufacturer_name
ndc	package	53045-206-08	openfda.package_ndc
ndc	package	53045-206-17	openfda.package_ndc
ndc	product	53045-206	openfda.product_ndc
ndc11	package	53045020617	derived:openfda.package_ndc
ndc11	package	53045020608	derived:openfda.package_ndc
rxcui		1535362	openfda.rxcui
spl id		373417c2-b73d-4928-978a-ffa2b4b38746	id
spl set id		bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4	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 and cautions

Keep out of the 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. Do not use on patients with an allergy Fluoride. Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist. For professional use only.

Reported adverse events (FAERS/openFDA)#

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