MIPaste One

Product NDC
61596-400
11-digit product format
615960400
Labeler code
61596
Product ID
61596-400_4651d664-464b-05c1-e063-6394a90a565e
Type
HUMAN OTC DRUG
Nonproprietary name
MIPaste One
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
GC America Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-03
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .24 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MIPaste One
Listing expiration
2026-12-31

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
61596-400-10MIPaste One10 in 1 BOXPASTE, DENTIFRICE103
61596-400-40MIPaste One46 g in 1 TUBEPASTE, DENTIFRICE463
61596-400-41MIPaste One1 in 1 BOXPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-400MIPASTE ONE PASTE, DENTIFRICE [GC AMERICA INC.]2Current NDC, Legacy NDC, 3 package rows20240128_d71f8e6e-7005-4b3e-e053-2995a90a6789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNd71f8e6e-7005-4b3e-e053-2995a90a67893
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDd71f8e6e-7005-4b3e-e053-2995a90a67893
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYd71f8e6e-7005-4b3e-e053-2995a90a67893
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYd71f8e6e-7005-4b3e-e053-2995a90a67893
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYd71f8e6e-7005-4b3e-e053-2995a90a67893
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYd71f8e6e-7005-4b3e-e053-2995a90a67893
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYd71f8e6e-7005-4b3e-e053-2995a90a67893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61596-400-106159604001010 BOX in 1 BOX (61596-400-10) / 1 TUBE in 1 BOX (61596-400-41) / 46 g in 1 TUBE (61596-400-40) 10 box2022-02-030000-00-00NoNoCurrent
61596-400-406159604004046 g in 1 TUBE46 gHistorical
61596-400-41615960400411 in 1 BOXHistorical