Ionite APF Neutral

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 Neutral
Generic name: SODIUM FLUORIDE
Manufacturer: Dharma Research, inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 8191554f-adb6-4ba9-aa80-0a9bb65193ec
SPL ID: aed31a6c-2771-41cf-a35a-785e4a776366
Version: 2
Effective date: 2020-10-27
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:48:32

Harmonized routes table
Harmonized routes
DENTAL, ORAL, 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 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Ionite APF Neutral	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Dharma Research, inc.	openfda.manufacturer_name
ndc	package	53045-237-17	openfda.package_ndc
ndc	product	53045-237	openfda.product_ndc
ndc11	package	53045023717	derived:openfda.package_ndc
spl id		aed31a6c-2771-41cf-a35a-785e4a776366	id
spl set id		8191554f-adb6-4ba9-aa80-0a9bb65193ec	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. For professional use only.

Reported adverse events (FAERS/openFDA)#

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