FDA.reportPublic FDA data

Made by Dentists Sensitive and Whitening Fresh Mint

Product NDC
75065-029
11-digit product format
750650029
Labeler code
75065
Product ID
75065-029_125c746e-12f0-07cf-e063-6294a90ac1ca
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
2024-02-22
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.5 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Made by Dentists Sensitive and Whitening Fresh Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN0d379c26-69ff-4666-9ad5-7618f0bd139f1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD0d379c26-69ff-4666-9ad5-7618f0bd139f1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY0d379c26-69ff-4666-9ad5-7618f0bd139f1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY0d379c26-69ff-4666-9ad5-7618f0bd139f1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY0d379c26-69ff-4666-9ad5-7618f0bd139f1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY0d379c26-69ff-4666-9ad5-7618f0bd139f1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY0d379c26-69ff-4666-9ad5-7618f0bd139f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75065-029-06750650029061 TUBE in 1 CARTON (75065-029-06) / 120 g in 1 TUBE1 tube2024-02-22NoNoCurrent