Ionite H

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 H
Generic name: SODIUM FLUORIDE, POTASSIUM NITRATE
Manufacturer: Dharma Research, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 54c1a27c-5936-4ee2-a419-3891d3df9745
SPL ID: 0b21c890-82f5-4e90-8aa1-1e06d631760e
Version: 1
Effective date: 2015-08-02
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:56:15

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Ionite H	openfda.brand_name
generic name		SODIUM FLUORIDE, POTASSIUM NITRATE	openfda.generic_name
manufacturer name		Dharma Research, Inc.	openfda.manufacturer_name
ndc	package	53045-280-04	openfda.package_ndc
ndc	product	53045-280	openfda.product_ndc
ndc11	package	53045028004	derived:openfda.package_ndc
rxcui		637365	openfda.rxcui
spl id		0b21c890-82f5-4e90-8aa1-1e06d631760e	id
spl set id		54c1a27c-5936-4ee2-a419-3891d3df9745	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RU45X2JN0Z	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. If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product for longer than 4 weeks unless recommended by a dentist or physician.

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.