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: STANNOUS FLUORIDE
Manufacturer: Burkhart Dental Supply Inc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 47142a7d-3095-4ea6-b977-80e9f2cc8958
SPL ID: d70dc1ee-062b-64d4-e053-2995a90a7559
Version: 3
Effective date: 2022-02-02
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:07

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Burkhart	openfda.brand_name
generic name		STANNOUS FLUORIDE	openfda.generic_name
manufacturer name		Burkhart Dental Supply Inc	openfda.manufacturer_name
ndc	package	43498-201-10	openfda.package_ndc
ndc	product	43498-201	openfda.product_ndc
ndc11	package	43498020110	derived:openfda.package_ndc
rxcui		583459	openfda.rxcui
spl id		d70dc1ee-062b-64d4-e053-2995a90a7559	id
spl set id		47142a7d-3095-4ea6-b977-80e9f2cc8958	set_id
unii		3FTR44B32Q	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 more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use until diluted. This product may produce surface staining of the teeth. Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Reported adverse events (FAERS/openFDA)#

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