Made by Dentists Sensitive and Whitening Fresh Mint

Manufacturer
MADE BY DENTISTS INC
Effective date
2024-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:02

Label at a glance#

ProductMade by Dentists Sensitive and Whitening Fresh Mint
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure7 sections

Dosage and administration

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5.0%

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

Purpose

OTC - PURPOSE SECTION

Antisensitivity

Anticavity 

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Warnings:

WARNINGS SECTION

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

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 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor.
  • Make sure to brush all sensitive areas of the teeth.
  • Children under 12 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, Sodium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate

Questions or comments?

OTC - QUESTIONS SECTION

+ 1 (646) 980-6461

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabeltube labeltube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY1

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
75065-029-06Made by Dentists Sensitive and Whitening Fresh Mint1 in 1 CARTONPASTE11
75065-029-06Made by Dentists Sensitive and Whitening Fresh Mint120 g in 1 TUBEPASTE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75065-029MADE BY DENTISTS SENSITIVE AND WHITENING FRESH MINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [MADE BY DENTISTS INC]1Current NDC, 2 package rows20240229_0d379c26-69ff-4666-9ad5-7618f0bd139f.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-02975065-029-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
ndc (package): 75065-029-06
ndc (product): 75065-029
ndc11 (package): 75065002906
spl id: 125c746e-12f0-07cf-e063-6294a90ac1ca
spl set id: 0d379c26-69ff-4666-9ad5-7618f0bd139f

Reported adverse events (FAERS/openFDA)#

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