FDA.reportPublic FDA data

Denti-Care

Manufacturer
AR Medicom Inc
Effective date
2011-02-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:11:20

Label at a glance#

ProductDenti-Care Topical Fluoride Foam Raspberry
Active ingredientsodium fluoride, HYDROFLUORIC ACID
Label structure6 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Denti-Care

Denti-Foam

Topical Fluoride Foam Raspberry

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1378-1

DOSAGE & ADMINISTRATION SECTION


A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

130 applications

Medicinal ingredients:

Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04% hydrofluoric acid)

INACTIVE INGREDIENT SECTION

Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone C30, glycerin USP, propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid, purified water, raspberry flavor

WARNINGS AND PRECAUTIONS SECTION

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx Only

SPL UNCLASSIFIED SECTION

Manufactured in Canada for
AR Medicom Inc
Montreal, Canada, H8T 3J8
Questions 1-800-361-2862 or www.medicom.com
UPC 686864018704
Item code 10037-RB
Rev 00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10037foamrb10037foamrb

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090053sodium fluoride 1.76 % / hydrofluoric acid 1.04 % Oral FoamPSN1
1090053hydrofluoric acid 10.4 MG/ML / sodium fluoride 17.6 MG/ML Oral FoamSCD1
1090053hydrofluoric acid 1.04 % / sodium fluoride 1.76 % (fluoride ion 1.23 % ) Oral FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64778-1378-12019-10-29C16284748780-1960f7f55-c7f7-8e05-e053-dbdaa90a074aDenti-Care Denti-Foam Topical Fluoride Foam Raspberry 1.23 % Fluoride Ions

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64778-1378-1Denti-CareTopical Fluoride Foam Raspberry125 g in 1 BOTTLE, SPRAYAEROSOL, FOAM1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64778-1378DENTI-CARE TOPICAL FLUORIDE FOAM RASPBERRY (FLUORIDE IONS) AEROSOL, FOAM [AR MEDICOM INC]1Legacy NDC, 1 package rows20110210_4a7ea46a-9799-418d-b277-550e9f0a0612.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ1
sodium fluorideACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64778-137864778-1378-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
sodium fluoride8ZYQ1474W7ACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIB

Source Document#

Source XML

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
0ef082fc-d68a-432b-adbf-dc67a578f3ad4a7ea46a-9799-418d-b277-550e9f0a06122011-02-09WarningsExact identifier
spl id: 0ef082fc-d68a-432b-adbf-dc67a578f3ad
spl set id: 4a7ea46a-9799-418d-b277-550e9f0a0612

Reported adverse events (FAERS/openFDA)#

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