Burkhart

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: Burkhart
Generic name: SODIUM FLUORIDE
Manufacturer: Burkhart Dental Supply Inc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 8d1997c0-4f61-46b5-954e-620d521d3fba
SPL ID: d70e60bc-60c2-c66c-e053-2a95a90a106f
Version: 4
Effective date: 2022-02-02
Source export date: 2026-11-06
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:53:48

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 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Burkhart	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Burkhart Dental Supply Inc	openfda.manufacturer_name
ndc	package	43498-107-15	openfda.package_ndc
ndc	product	43498-107	openfda.product_ndc
ndc11	package	43498010715	derived:openfda.package_ndc
spl id		d70e60bc-60c2-c66c-e053-2a95a90a106f	id
spl set id		8d1997c0-4f61-46b5-954e-620d521d3fba	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

Warnings: Keep out of 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. Read directions carefully before using.

Reported adverse events (FAERS/openFDA)#

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