Made By Dentists, Inc. Rebuilding

Product NDC
75065-019
11-digit product format
750650019
Labeler code
75065
Product ID
75065-019_456be3fd-86c2-7318-e063-6294a90adba6
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE
Route
DENTAL
Labeler
Made By Dentists, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-24
Marketing end
2026-06-30
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .24 g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Made By Dentists, Inc. Rebuilding

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.24 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75065-019MADE BY DENTISTS, INC. REBUILDING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [MADE BY DENTISTS, INC.]4Current NDC, 2 package rows20250101_d85f52ca-6339-4ec2-a910-61ddca91a21d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNd85f52ca-6339-4ec2-a910-61ddca91a21d5
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDd85f52ca-6339-4ec2-a910-61ddca91a21d5
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYd85f52ca-6339-4ec2-a910-61ddca91a21d5
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYd85f52ca-6339-4ec2-a910-61ddca91a21d5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYd85f52ca-6339-4ec2-a910-61ddca91a21d5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYd85f52ca-6339-4ec2-a910-61ddca91a21d5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYd85f52ca-6339-4ec2-a910-61ddca91a21d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75065-019-06750650019061 TUBE in 1 CARTON (75065-019-06) / 120 g in 1 TUBE1 tube2023-01-242026-06-30NoNoHistorical