FDA.reportPublic FDA data

Acclean Anti-Cavity

Product NDC
0404-0173
11-digit product format
004040173
Labeler code
0404
Product ID
0404-0173_fd35a40b-539d-4a27-a7f2-e360cc07d71b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Henry Schein, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-01-28
Substance
SODIUM FLUORIDE
Active strength
1.1 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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7db9f10e-8f7b-41b2-a158-21e69e8256ebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0173-04Acclean Anti-Cavity113.4 g in 1 TUBEPASTE, DENTIFRICE113.41
0404-0173-04Acclean Anti-Cavity1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0173ACCLEAN ANTI-CAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HENRY SCHEIN, INC.]1Current NDC, 2 package rows20250221_7db9f10e-8f7b-41b2-a158-21e69e8256eb.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-CavitySODIUM FLUORIDEHenry Schein, Inc.7db9f10e-8f7b-41b2-a158-21e69e8256eb2024-11-14Warnings, Adverse reactionsExact identifier
ndc (product): 0404-0173

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
392038sodium fluoride 1.1 % ToothpastePSN7db9f10e-8f7b-41b2-a158-21e69e8256eb1
392038sodium fluoride 0.011 MG/MG ToothpasteSCD7db9f10e-8f7b-41b2-a158-21e69e8256eb1
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY7db9f10e-8f7b-41b2-a158-21e69e8256eb1
392038sodium fluoride 1.1 % Dental GelSY7db9f10e-8f7b-41b2-a158-21e69e8256eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-0173-04004040173041 TUBE in 1 CARTON (0404-0173-04) / 113.4 g in 1 TUBE1 tube2025-01-28NoNoCurrent