Made By Dentists, Inc. Rebuilding

Manufacturer
Made By Dentists, Inc. | Massco Dental
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:44

Label at a glance#

ProductMade By Dentists, Inc. Rebuilding
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24%

OTC - PURPOSE SECTION

Purpose

Potassium Nitrate ....  Desensitizer

Sodium Fluoride ....... Anticavity

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings:

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.

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 accidentally swallowed, get
medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:
• 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 INGREDIENT SECTION

Inactive Ingredients:
Cellulose Gum, Citric Acid, Cocamidopropyl
Betaine, Flavor, Hydrated Silica, Hydroxyapatite,
Potassium Sorbate, Sodium Bicarbonate, Sodium
Saccharin, Sodium Tripolyphosphate, Sorbitol,
Titanium Dioxide, Water, Xylitol

OTC - QUESTIONS SECTION

Questions?  +1 (646) 980-6461

Rebuilding Toothpaste Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rebuilding Toothpaste

Made By Dentists ​™

Fresh Mint Flavor

NET WT 4.2 Oz / 120g

MADE IN THE USA

@Copyright: 2022 Made By Dentists

439 S. Cedros Avenue, Suite 402.

Solana Beach, CA, 92075

Carton

Rebuilding carton-019Rebuilding carton-019

Tube

Rebuilding tube-019Rebuilding tube-019

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN5
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD5
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY5
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75065-019-06Made By Dentists, Inc. Rebuilding120 g in 1 TUBEPASTE1205
75065-019-06Made By Dentists, Inc. Rebuilding1 in 1 CARTONPASTE15

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-01975065-019-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
456be3fd-86c2-7318-e063-6294a90adba6d85f52ca-6339-4ec2-a910-61ddca91a21d2025-12-08WarningsExact identifier
spl id: 456be3fd-86c2-7318-e063-6294a90adba6
spl set id: d85f52ca-6339-4ec2-a910-61ddca91a21d

Reported adverse events (FAERS/openFDA)#

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