BIOTENE Fresh Mint Original

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: BIOTENE Fresh Mint Original
Generic name: SODIUM FLUORIDE
Manufacturer: Haleon US Holdings LLC
Product type: HUMAN OTC DRUG
SPL set ID: 1101c17f-c848-4cd5-a7cd-679b59dbe1bf
SPL ID: 95462fd1-5eb4-46ff-bf63-a5e610337bc6
Version: 10
Effective date: 2024-11-05
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:12

Harmonized routes table
Harmonized routes
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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		BIOTENE Gentle Mint	openfda.brand_name
brand name		BIOTENE Fresh Mint Original	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Haleon US Holdings LLC	openfda.manufacturer_name
ndc	package	0135-0558-01	openfda.package_ndc
ndc	package	0135-0557-02	openfda.package_ndc
ndc	package	0135-0557-01	openfda.package_ndc
ndc	product	0135-0558	openfda.product_ndc
ndc	product	0135-0557	openfda.product_ndc
ndc11	package	00135055701	derived:openfda.package_ndc
ndc11	package	00135055801	derived:openfda.package_ndc
ndc11	package	00135055702	derived:openfda.package_ndc
rxcui		1044547	openfda.rxcui
rxcui		416783	openfda.rxcui
spl id		95462fd1-5eb4-46ff-bf63-a5e610337bc6	id
spl set id		1101c17f-c848-4cd5-a7cd-679b59dbe1bf	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 12 years of age and under (Fresh Mint and Gentle Mint) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients. Keep out of reach of children 12 years of age and under. (PBF) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients.

Reported adverse events (FAERS/openFDA)#

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