biotene

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
Generic name: SODIUM MONOFLUOROPHOSPHATE
Manufacturer: Haleon US Holdings LLC
Product type: HUMAN OTC DRUG
SPL set ID: a47a6502-efb2-4072-9562-cbe293531c2b
SPL ID: c26f08a5-fa67-417e-8499-015edb65f7f8
Version: 9
Effective date: 2024-11-04
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 06:54:36

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		biotene	openfda.brand_name
generic name		SODIUM MONOFLUOROPHOSPHATE	openfda.generic_name
manufacturer name		Haleon US Holdings LLC	openfda.manufacturer_name
ndc	package	0135-0577-01	openfda.package_ndc
ndc	product	0135-0577	openfda.product_ndc
ndc11	package	00135057701	derived:openfda.package_ndc
rxcui		545626	openfda.rxcui
spl id		c26f08a5-fa67-417e-8499-015edb65f7f8	id
spl set id		a47a6502-efb2-4072-9562-cbe293531c2b	set_id
unii		C810JCZ56Q	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 When using this product, if irritation occurs discontinue use. Keep out of reach of children under 6 years of age. If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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