Cavity Protection

Manufacturer: Tom's of Maine, Inc.
Effective date: 2011-05-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:28:00

Label at a glance#

ProductCavity Protection Peppermint with baking soda

Active ingredientSodium Monofluorophosphate

Label structure10 sections

Dosage and administration

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Contacts and useful links#

PhoneLabel contact(412) 390-3381

PhoneLabel contact1-800-FOR-TOMS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, sodium lauryl sulfate.

Questions?

OTC - QUESTIONS SECTION

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 155.9 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINCE 1970
Tom's
OF MAINE™

baking soda ∣ natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

peppermint

ADA
Accepted
American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

PRINCIPAL DISPLAY PANEL - 155.9 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINCE 1970
Tom's
OF MAINE™

natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

spearmint

ADA
Accepted
American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	2
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51009-116-55	2020-01-31	C162847	48780-1	9d75b9d0-dad1-f424-e053-dadaa90a57ce	Tom's OF MAINE CAVITY PROTECTION fluoride toothpaste
51009-120-55	2020-01-31	C162847	48780-1	9d75b9d0-dad1-f424-e053-dadaa90a57ce	Tom's OF MAINE CAVITY PROTECTION fluoride toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51009-116-55	Cavity Protection Spearmint	155.9 g in 1 TUBE	PASTE, DENTIFRICE	155.9	2
51009-116-55	Cavity Protection Spearmint	1 in 1 CARTON	PASTE, DENTIFRICE	1	2
51009-120-55	Cavity Protection Peppermint with baking soda	1 in 1 CARTON	PASTE, DENTIFRICE	1	2
51009-120-55	Cavity Protection Peppermint with baking soda	155.9 g in 1 TUBE	PASTE, DENTIFRICE	155.9	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51009-116	CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2	Legacy NDC, 2 package rows	20110512_f1cba5ce-852e-424a-b274-4a514505156b.zip
51009-120	CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2	Legacy NDC, 2 package rows	20110512_f1cba5ce-852e-424a-b274-4a514505156b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	2
Fluoride ion	ACTIVE MOIETY	Q80VPU408O	2
Calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	2
Carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	2
Sodium Bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	2
Spearmint Oil	INACTIVE INGREDIENT	C3M81465G5	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Cavity Protection Peppermint with baking soda
Sodium Monofluorophosphate
Fluoride ion
Calcium carbonate
Glycerin
Water
Sodium Bicarbonate
Carrageenan
Xylitol
Sodium Lauryl Sulfate
Peppermint oil
Cavity Protection Spearmint
Spearmint Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51009-120	51009-120-55
51009-116	51009-116-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Monofluorophosphate	C810JCZ56Q	ACTIB
Calcium carbonate	H0G9379FGK	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Sodium Bicarbonate	8MDF5V39QO	IACT
Carrageenan	5C69YCD2YJ	IACT
Xylitol	VCQ006KQ1E	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Peppermint oil	AV092KU4JH	IACT
Sodium Monofluorophosphate	C810JCZ56Q	ACTIB
Calcium carbonate	H0G9379FGK	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Xylitol	VCQ006KQ1E	IACT
Carrageenan	5C69YCD2YJ	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Spearmint Oil	C3M81465G5	IACT
Peppermint oil	AV092KU4JH	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 4 · 216 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	TABLET, CHEWABLE / ORAL		1650 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, SOLUTION / INTRAVENOUS		52 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, EXTENDED RELEASE / ORAL		81 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	GRANULE, FOR SUSPENSION / ORAL		161 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Calcium carbonate	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / BUCCAL		240 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	TABLET / ORAL		15 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, CHEWABLE / ORAL	140 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	SOLUTION / RESPIRATORY (INHALATION)	2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE / ORAL		320 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, DELAYED RELEASE / ORAL		199 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING / ORAL		107 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET / SUBLINGUAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	POWDER / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	TABLET / SUBLINGUAL	0.4 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	POWDER / NASAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	SUSPENSION / ORAL	0.59 mg/20ml		Exact identifier — unii candidate 7 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		3059 mg	Exact identifier — unii candidate 34 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
873dc868-9a54-452c-ae24-e090e8464a05			f1cba5ce-852e-424a-b274-4a514505156b	2011-05-10	Warnings	Exact identifier spl id: 873dc868-9a54-452c-ae24-e090e8464a05 spl set id: f1cba5ce-852e-424a-b274-4a514505156b

Reported adverse events (FAERS/openFDA)#

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