Made by Dentists Ultra Whitening Fresh Mint

Manufacturer: MADE BY DENTISTS INC
Effective date: 2024-03-15
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:09:53

Label at a glance#

ProductMade by Dentists Ultra Whitening Fresh Mint

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...

Contacts and useful links#

PhoneLabel contact1 (646) 980-6461

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 75065-027-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Labell.jpgLabel2.jpg

Label 75065-027-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	2
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	2
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	2
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	2
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75065-027-06	Made by Dentists Ultra Whitening Fresh Mint	120 g in 1 TUBE	PASTE	120	2
75065-027-06	Made by Dentists Ultra Whitening Fresh Mint	1 in 1 CARTON	PASTE	1	2
75065-027-07	Made by Dentists Ultra Whitening Fresh Mint	1 in 1 CARTON	PASTE	1	2
75065-027-07	Made by Dentists Ultra Whitening Fresh Mint	20 g in 1 TUBE	PASTE	20	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75065-027	MADE BY DENTISTS ULTRA WHITENING FRESH MINT (SODIUM FLUORIDE) PASTE [MADE BY DENTISTS INC]	2	Current NDC, 4 package rows	20240316_dbce2aba-48db-4e78-bf79-74f34868ee37.zip

Products#

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

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

Made by Dentists Ultra Whitening Fresh Mint
SODIUM FLUORIDE
WATER
SORBITOL
HYDRATED SILICA
XYLITOL
COCAMIDOPROPYL BETAINE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM TRIPOLYPHOSPHATE ANHYDROUS
TITANIUM DIOXIDE
POTASSIUM SORBATE
HYDROGEN PEROXIDE
SODIUM BICARBONATE
FLUORIDE ION
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75065-027	75065-027-06, 75065-027-07

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
XYLITOL	VCQ006KQ1E	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS	9SW4PFD2FZ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SACCHARIN SODIUM	SB8ZUX40TY	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Made by Dentists Ultra Whitening Fresh Mint	SODIUM FLUORIDE	MADE BY DENTISTS INC	dbce2aba-48db-4e78-bf79-74f34868ee37	2024-03-15	Warnings	Exact identifier ndc (package): 75065-027-07 ndc (package): 75065-027-06 ndc (product): 75065-027 ndc11 (package): 75065002707 ndc11 (package): 75065002706 spl id: 13b86adc-f15f-de02-e063-6294a90a4ac4 spl set id: dbce2aba-48db-4e78-bf79-74f34868ee37

Reported adverse events (FAERS/openFDA)#

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