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: 1009afc7-6e9d-417f-a702-f8a941e08484
SPL ID: 87ff143d-62ff-4b12-8800-ca730c2dce0a
Version: 2
Effective date: 2020-11-06
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:39:15

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	53045-266-64	openfda.package_ndc
ndc	product	53045-266	openfda.product_ndc
ndc11	package	53045026664	derived:openfda.package_ndc
rxcui		251960	openfda.rxcui
spl id		87ff143d-62ff-4b12-8800-ca730c2dce0a	id
spl set id		1009afc7-6e9d-417f-a702-f8a941e08484	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.