FDA.reportPublic FDA data

Kroger Enamel Protection Sensitive

Product NDC
30142-362
11-digit product format
301420362
Labeler code
30142
Product ID
30142-362_437f97f2-a999-5c11-e063-6394a90a312d
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Kroger Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-25
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 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
Kroger Enamel Protection Sensitive
Brand name suffix
Gentle Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-362-99Kroger Enamel Protection SensitiveGentle Whitening113 g in 1 TUBEPASTE, DENTIFRICE11314
30142-362-99Kroger Enamel Protection SensitiveGentle Whitening1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-362KROGER ENAMEL PROTECTION SENSITIVE GENTLE WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]12Current NDC, Legacy NDC, 2 package rows20250119_82b9a954-2a53-ac56-e053-2991aa0abd0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN82b9a954-2a53-ac56-e053-2991aa0abd0e14
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD82b9a954-2a53-ac56-e053-2991aa0abd0e14
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY82b9a954-2a53-ac56-e053-2991aa0abd0e14
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY82b9a954-2a53-ac56-e053-2991aa0abd0e14
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY82b9a954-2a53-ac56-e053-2991aa0abd0e14
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY82b9a954-2a53-ac56-e053-2991aa0abd0e14
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY82b9a954-2a53-ac56-e053-2991aa0abd0e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-362-99301420362991 TUBE in 1 CARTON (30142-362-99) / 113 g in 1 TUBE1 tube2019-02-250000-00-00NoNoCurrent