Ionite R

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 R
Generic name: SODIUM FLUORIDE
Manufacturer: Dharma Research, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5
SPL ID: ff676d2f-3188-4d27-b6a4-83e164154381
Version: 2
Effective date: 2020-11-06
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:24:37

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Ionite R	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Dharma Research, Inc.	openfda.manufacturer_name
ndc	package	53045-265-64	openfda.package_ndc
ndc	product	53045-265	openfda.product_ndc
ndc11	package	53045026564	derived:openfda.package_ndc
rxcui		251960	openfda.rxcui
spl id		ff676d2f-3188-4d27-b6a4-83e164154381	id
spl set id		0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5	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

WARNINGS AND PRECAUTIONS Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.

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 Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Reported adverse events (FAERS/openFDA)#

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