FDA.reportPublic FDA data

dentalux SENSITIVE ANTI-CAVITY FLUORIDE

Product NDC
71141-187
11-digit product format
711410187
Labeler code
71141
Product ID
71141-187_fc734f34-1c0f-4211-b5aa-bbd0ba55d821
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate, Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Lidl US, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-30
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
dentalux SENSITIVE ANTI-CAVITY FLUORIDE
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
71141-187-10dentalux SENSITIVE ANTI-CAVITY FLUORIDE1 in 1 BOXPASTE, DENTIFRICE11
71141-187-10dentalux SENSITIVE ANTI-CAVITY FLUORIDE113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-187DENTALUX SENSITIVE ANTI-CAVITY FLUORIDE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [LIDL US, LLC]1Current NDC, 2 package rows20241121_baef7f15-8082-4e61-8c08-8beda8ad40c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNbaef7f15-8082-4e61-8c08-8beda8ad40c01
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDbaef7f15-8082-4e61-8c08-8beda8ad40c01
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYbaef7f15-8082-4e61-8c08-8beda8ad40c01
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYbaef7f15-8082-4e61-8c08-8beda8ad40c01
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYbaef7f15-8082-4e61-8c08-8beda8ad40c01
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYbaef7f15-8082-4e61-8c08-8beda8ad40c01
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYbaef7f15-8082-4e61-8c08-8beda8ad40c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71141-187-10711410187101 TUBE in 1 BOX (71141-187-10) / 113 g in 1 TUBE1 tube2024-06-30NoNoHistorical