FDA.reportPublic FDA data

Acclean Anti-Cavity Sensitivity Relief

Product NDC
0404-0174
11-digit product format
004040174
Labeler code
0404
Product ID
0404-0174_170263e7-b523-4250-b542-5bddab28ae43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Henry Schein, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-01-30
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; 1.1 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
Acclean Anti-Cavity Sensitivity Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE1.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui637365

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0174-04Acclean Anti-Cavity Sensitivity Relief113.4 g in 1 TUBEPASTE, DENTIFRICE113.41
0404-0174-04Acclean Anti-Cavity Sensitivity Relief1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0174ACCLEAN ANTI-CAVITY SENSITIVITY RELIEF (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [HENRY SCHEIN, INC.]1Current NDC, 2 package rows20250221_d5dc57d9-e62d-4b58-a5df-de4e37238dd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSNd5dc57d9-e62d-4b58-a5df-de4e37238dd71
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCDd5dc57d9-e62d-4b58-a5df-de4e37238dd71
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYd5dc57d9-e62d-4b58-a5df-de4e37238dd71
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYd5dc57d9-e62d-4b58-a5df-de4e37238dd71
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSYd5dc57d9-e62d-4b58-a5df-de4e37238dd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-0174-04004040174041 TUBE in 1 CARTON (0404-0174-04) / 113.4 g in 1 TUBE1 tube2025-01-30NoNoHistorical