FreshDent Cavity Protection Anticavity

Manufacturer: FreshDent LLC | Swiss Egyptian Co. For Oral Care Products and Cosmetics
Effective date: 2014-11-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:44

Label at a glance#

ProductFreshDent Cavity Protection Anticavity

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure8 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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Contacts and useful links#

PhoneLabel contact+1-512-653-8814

Websitewww.freshdent.net

www.freshdent.net

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.085% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Keep out of Reach of children

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 contact a Poison Control Center right away.

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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Calcium Carbonate, Sodium Lauryl Sulfate,Carboxymethyl Cellulose, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Methyl Paraben, FD&C Blue 1.

Questions?

OTC - QUESTIONS SECTION

+1-512-653-8814

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticavity Toothpaste

FreshDent

we care

Cavity Protection

Strengthens teeth with Active Fluoride

Net Wt. 0.85 oz (24 g)

Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt

CavityBoxCavityTube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69338-002-01	2020-01-31	C162847	48780-1	9d75b9d0-0cd9-f424-e053-dadaa90a57ce	FreshDent Anticavity Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69338-002-01	FreshDent Cavity Protection Anticavity	24 g in 1 TUBE	PASTE, DENTIFRICE	24		1
69338-002-01	FreshDent Cavity Protection Anticavity	1 in 1 CARTON	PASTE, DENTIFRICE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69338-002	FRESHDENT CAVITY PROTECTION ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [FRESHDENT LLC]	1	Legacy NDC, 2 package rows	20141106_16ac653c-0bad-4d3b-a060-1be1444f28af.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
METHYLPARABEN SODIUM	INACTIVE INGREDIENT	CR6K9C2NHK	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

FreshDent Cavity Protection Anticavity
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION
SORBITOL
GLYCERIN
WATER
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SACCHARIN SODIUM
METHYLPARABEN SODIUM
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69338-002	69338-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 6 · 335 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 / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN SODIUM	METHYLPARABEN SODIUM	CR6K9C2NHK	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
METHYLPARABEN SODIUM	METHYLPARABEN SODIUM	CR6K9C2NHK	POWDER, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 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 candidate 37 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
a5acc4f6-b53f-4a17-a889-ef681cfdf27b			16ac653c-0bad-4d3b-a060-1be1444f28af	2014-11-06	Warnings	Exact identifier spl id: a5acc4f6-b53f-4a17-a889-ef681cfdf27b spl set id: 16ac653c-0bad-4d3b-a060-1be1444f28af

Reported adverse events (FAERS/openFDA)#

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