FDA.reportPublic FDA data

Acclean Foam Fluoride 60 Second Application

Manufacturer
Henry Schein
Effective date
2023-10-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:53:38

Label at a glance#

ProductAcclean Foam Fluoride 60 Second Application
Active ingredientSODIUM FLUORIDE
Label structure5 sections

Label contents#

Full prescribing information#

General Information

DESCRIPTION SECTION

Henry Schein, Inc.

Acclean Foam Fluoride 60 Second Application

Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion)

Contains:

Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant.

Gluten free.

Indications

INDICATIONS & USAGE SECTION

For topical application to aid in the protection against dental caries.

Warnings

WARNINGS AND PRECAUTIONS SECTION

Contens under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 50-80F. Keep from freezing. do not spray toward open flame.

Instructions For Use

INSTRUCTIONS FOR USE SECTION

  • Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense, invert can completely upside down. Slowly depress nozzle to fill fluoride applicator tray (foam will expand slightly higher than fluoride tray).
  • Tooth surface must be dry prior to inserting tray(s) in mouth.
  • Insert tray(s) into mouth and have patient bite down for 1-4 minutes.
  • Remove tray(s) and have patient expectorate.
  • Advise patient not to eat, drink or rinse for 30 minutes after treatment.

Professional Use Only

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage LabelPackage LabelPackage LabelPackage LabelPackage LabelPackage LabelPackage LabelPackage LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248389sodium fluoride 2.72 % Oral FoamPSN3
248389sodium fluoride 27.2 MG/ML Oral FoamSCD3
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY3
248389sodium fluoride 2.72 % Oral FoamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-1701-44Acclean Foam Fluoride 60 Second Application125 g in 1 CANISTERAEROSOL, FOAM1253
0404-1711-44Acclean Foam Fluoride 60 Second Application125 g in 1 CANISTERAEROSOL, FOAM1253
0404-1721-44Acclean Foam Fluoride 60 Second Application125 g in 1 CANISTERAEROSOL, FOAM1253
0404-1731-44Acclean Foam Fluoride 60 Second Application125 g in 1 CANISTERAEROSOL, FOAM1253
0404-1741-44Acclean Foam Fluoride 60 Second Application125 g in 1 CANISTERAEROSOL, FOAM1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-1701ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION (SODIUM FLUORIDE) AEROSOL, FOAM [HENRY SCHEIN]3Current NDC, Legacy NDC, 1 package rows20231004_c10af938-0537-2425-e053-2a95a90ad608.zip
0404-1711ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION (SODIUM FLUORIDE) AEROSOL, FOAM [HENRY SCHEIN]3Current NDC, Legacy NDC, 1 package rows20231004_c10af938-0537-2425-e053-2a95a90ad608.zip
0404-1721ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION (SODIUM FLUORIDE) AEROSOL, FOAM [HENRY SCHEIN]3Current NDC, Legacy NDC, 1 package rows20231004_c10af938-0537-2425-e053-2a95a90ad608.zip
0404-1731ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION (SODIUM FLUORIDE) AEROSOL, FOAM [HENRY SCHEIN]3Current NDC, Legacy NDC, 1 package rows20231004_c10af938-0537-2425-e053-2a95a90ad608.zip
0404-1741ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION (SODIUM FLUORIDE) AEROSOL, FOAM [HENRY SCHEIN]3Legacy NDC, 1 package rows20231004_c10af938-0537-2425-e053-2a95a90ad608.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-17310404-1731-44
0404-17110404-1711-44
0404-17010404-1701-44
0404-17210404-1721-44
0404-17410404-1741-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
BETAINE3SCV180C9WIACT
XYLITOLVCQ006KQ1EIACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
BETAINE3SCV180C9WIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLOXAMER 407TUF2IVW3M2IACT
BETAINE3SCV180C9WIACT
POLOXAMER 407TUF2IVW3M2IACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
BETAINE3SCV180C9WIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLOXAMER 407TUF2IVW3M2IACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
BETAINE3SCV180C9WIACT

Source Document#

Source XML

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 Foam Fluoride 60 Second ApplicationSODIUM FLUORIDEHenry Scheinc10af938-0537-2425-e053-2a95a90ad6082023-10-03WarningsExact identifier
ndc (package): 0404-1701-44
ndc (package): 0404-1721-44
ndc (package): 0404-1711-44
ndc (package): 0404-1741-44
ndc (package): 0404-1731-44
ndc (product): 0404-1741
ndc (product): 0404-1731
ndc (product): 0404-1721
ndc (product): 0404-1701
ndc (product): 0404-1711
ndc11 (package): 00404174144
ndc11 (package): 00404170144
ndc11 (package): 00404172144
ndc11 (package): 00404171144
ndc11 (package): 00404173144
spl id: 06d4de64-6d8f-6bfb-e063-6294a90a40eb
spl set id: c10af938-0537-2425-e053-2a95a90ad608

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.