Made by Dentists Ultra Whitening Professional

Manufacturer
Fulijaya Manufacturing Sdn. Bhd
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:52

Label at a glance#

ProductMade by Dentists Ultra Whitening Professional
Active ingredientSODIUM FLUORIDE
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), and only use a pea size amount. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentis...

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity 

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities.

Warnings:

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentlly 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), and only use a pea size amount.
  • 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

Water (Aqua), Sorbitol, Hydrated Silica, Xylitol, Flavor, Cocamidopropyl Betaine, Cellulose Gum, Pentasodium Triphosphate, Titanium Dioxide, Sordium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate

Questions or comments?

OTC - QUESTIONS SECTION

+ 1 (646) 980-6461

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Labell.jpgLabell.jpgLabel2.jpgLabel2.jpg

Label: 62776-005-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel tubeLabel tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850031970700GTIN-13: 0850031970700
EAN-13: 0850031970700
GTIN-12: 850031970700
UPC-A: 850031970700
GTIN storage (14 digits): 00850031970700
Labell.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
62776-005-01Made by Dentists Ultra Whitening Professional120 g in 1 TUBEPASTE1203
62776-005-01Made by Dentists Ultra Whitening Professional1 in 1 CARTONPASTE13
62776-005-02Made by Dentists Ultra Whitening Professional1 in 1 CARTONPASTE13
62776-005-02Made by Dentists Ultra Whitening Professional20 g in 1 TUBEPASTE203

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
62776-00562776-005-01, 62776-005-02

Ingredients#

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

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

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
386c23e2-b4fc-5f9a-e063-6294a90a506b177b26c8-6ad2-2e78-e063-6394a90afe6b2025-06-25WarningsExact identifier
spl id: 386c23e2-b4fc-5f9a-e063-6294a90a506b
spl set id: 177b26c8-6ad2-2e78-e063-6394a90afe6b

Reported adverse events (FAERS/openFDA)#

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