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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS DO NOT SWALLOW. Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Prolonged daily ingestion may result in various degrees of dental fluorosis in children with developing dentition, especially if the water fluoridation exceeds 0.6 ppm, since younger children frequently cannot perform the brushing process without significant swallowing. Use in children under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have rarely been reported.

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 tube2025-01-30NoNoCurrent