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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637365Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5dc57d9-e62d-4b58-a5df-de4e37238dd7Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acclean Anti-Cavity Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHenry Schein, Inc.d5dc57d9-e62d-4b58-a5df-de4e37238dd72024-11-14Warnings, Adverse reactionsExact identifier
ndc (product): 0404-0174

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 tube2025-01-30NoNoCurrent