biotene

Manufacturer: Haleon US Holdings LLC
Effective date: 2024-11-04
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:34:31

Label at a glance#

Productbiotene

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure10 sections

Dosage and administration

• adults and children 2 years of age and older: o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits...

Storage and handling

store at or below 25ºC (77ºF)

Contacts and useful links#

PhoneLabel contact1-800-922-5856

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

When using this product,

OTC - WHEN USING SECTION

if irritation occurs discontinue use.

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older:
- apply toothpaste onto a toothbrush
- brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing.
- to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
children under 2 years of age: Consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

store at or below 25ºC (77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-922-5856

Additional information

SPL UNCLASSIFIED SECTION

This product contains no Sodium Lauryl Sulfate (SLS)

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

@2019 GSK group of companies or its licensor.

Questions or Comments?

1-800-922-5856

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0577-01

biotene^®

Fluoride Toothpaste

SPECIALLY FORMULATED TO NOT IRRITATE

Helps prevent cavities & strengthen teeth

Gentle Formula

GENTLE MINT

NET WT 4.3 OZ (121.9g)

1000114 Front Carton

Biotene Gentle Mint Original 4.3 oz (121.9g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	9
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0135-0577-01	2024-11-05	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0577-01	2024-07-30	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0577-01	2024-01-30	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-01	2022-01-07	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-02	2022-01-07	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0577-01	2022-01-07	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-01	2020-09-27	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-02	2020-09-27	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0577-01	2020-09-27	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-01	2020-09-25	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-02	2020-09-25	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0577-01	2020-09-25	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-01	2020-07-22	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0487-02	2020-07-22	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts
0135-0577-01	2020-07-22	C162847	48780-1	ab0e2407-33a0-f274-e053-dbdaa90a6471	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0135-0577-01	biotene	1 in 1 CARTON	PASTE	1		9
0135-0577-01	biotene	121.9 g in 1 TUBE	PASTE	121.9		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0577	BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE [HALEON US HOLDINGS LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241107_a47a6502-efb2-4072-9562-cbe293531c2b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	4
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	4
CALCIUM LACTATE	INACTIVE INGREDIENT	2URQ2N32W3	4
CALCIUM PYROPHOSPHATE	INACTIVE INGREDIENT	X69NU20D19	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	4
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	4
DEXTRANASE PENICILLIUM	INACTIVE INGREDIENT	N2161X1O5O	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	4
GLUCOSE OXIDASE	INACTIVE INGREDIENT	0T8392U5N1	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	4
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	4
LACTOPEROXIDASE BOVINE	INACTIVE INGREDIENT	01UIN5OC49	4
LYSOZYME, CHICKEN EGG WHITE	INACTIVE INGREDIENT	1ZML031Y3C	4
MICA	INACTIVE INGREDIENT	V8A1AW0880	4
MUTANASE SCHIZOSACCHAROMYCES POMBE	INACTIVE INGREDIENT	7SOH7SS2HE	4
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	4
POTASSIUM THIOCYANATE	INACTIVE INGREDIENT	TM7213864A	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	4
SODIUM COPPER CHLOROPHYLLIN	INACTIVE INGREDIENT	1D276TYV9O	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	4
TALACTOFERRIN ALFA	INACTIVE INGREDIENT	7A055A9QRR	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

biotene
sodium monofluorophosphate
FLUORIDE ION
SORBITOL
GLYCERIN
CALCIUM PYROPHOSPHATE
WATER
HYDRATED SILICA
XYLITOL
SILICON DIOXIDE
HYDROXYETHYL CELLULOSE, UNSPECIFIED
ISOCETETH-20
XANTHAN GUM
SODIUM BENZOATE
CALCIUM LACTATE ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0135-0577	0135-0577-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CALCIUM PYROPHOSPHATE	X69NU20D19	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
XYLITOL	VCQ006KQ1E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
ISOCETETH-20	O020065R7Z	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CALCIUM LACTATE ANHYDROUS	2URQ2N32W3	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 298 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, DELAYED RELEASE / ORAL	4.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii+route 70 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	CAPSULE / ORAL		20 mg	Exact identifier — unii+route 14 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	POWDER, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii+route 30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii+route 70 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+dosage form 70 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 46 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	TABLET, EXTENDED RELEASE / ORAL	150 mg		Exact identifier — unii+route 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route 46 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	TABLET, EXTENDED RELEASE / ORAL	150 mg		Exact identifier — unii+route 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii+route 70 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	CONCENTRATE / ORAL		3 mg	Exact identifier — unii+route 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii+route 70 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii+route 46 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 70 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	SUSPENSION, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 38 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, CHEWABLE / ORAL	24.75 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii+route 70 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 46 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii+route 46 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii+route 70 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii+route 70 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SUSPENSION / ORAL		1200 mg	Exact identifier — unii+route 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 46 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii+route 70 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii+route 70 equally ranked IID candidates
POLOXAMER 188	POLOXAMER 188	LQA7B6G8JG	TABLET, EXTENDED RELEASE / ORAL		37 mg	Exact identifier — unii+route 30 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier ndc (package): 0135-0577-01 ndc (product): 0135-0577 ndc11 (package): 00135057701 spl id: c26f08a5-fa67-417e-8499-015edb65f7f8 spl set id: a47a6502-efb2-4072-9562-cbe293531c2b

Reported adverse events (FAERS/openFDA)#

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