FDA.reportPublic FDA data

Dentisse

Manufacturer
Dentisse, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:51

Label at a glance#

ProductDentisse
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities.

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 supevision. Children under 2 years of age, constult a dentist or a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

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 accidently 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 supevision.
  • Children under 2 years of age, constult a dentist or a doctor.

Other information

WARNINGS SECTION

For your protection, this tube has a foil seal under the cap.

Inactive ingredients

INACTIVE INGREDIENT SECTION

refined kaolin clay, purified water, sorbitol, vegetable glycerin, sodium laurly sulfate, cellulose gum, natural mint flavors, xylitol, bentonite clay, sodium citrate, sodium phosphate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Manufactured for Dentisse, Inc.

1-260-444-3046 Fort Wayne, IN 46825

www.dentisse.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTISSE ®

Anticavity Fluoride

Toothpaste

Natural Clay Based Whitening

Radiant Mint

Net Wt. 3.2 oz. (91 g)

Detisse_tube3.2_image.jpgDetisse_tube3.2_image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70683-0703-2Dentisse91 g in 1 TUBEPASTE, DENTIFRICE913

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70683-070370683-0703-2

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
NameUNIIKind
KAOLIN24H4NWX5COIACT
BENTONITEA3N5ZCN45CIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
MENTHOLL7T10EIP3AIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-12-19full-release2026-06-01 00:04:54

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
ndc (package): 70683-0703-2
ndc (product): 70683-0703
ndc11 (package): 70683070302
spl id: 42c83cbe-24d7-6ccb-e063-6294a90ab55b
spl set id: 326b290a-9bd2-468e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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