FDA.reportPublic FDA data

Acclean Foam Fluoride 60 Second Application

Product NDC
0404-1701
11-digit product format
004041701
Labeler code
0404
Product ID
0404-1701_06d4de64-6d8f-6bfb-e063-6294a90a40eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
AEROSOL, FOAM
Route
DENTAL
Labeler
Henry Schein
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-04-28
Substance
SODIUM FLUORIDE
Active strength
.0272 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acclean Foam Fluoride 60 Second Application
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.0272 g/g

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
248389Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c10af938-0537-2425-e053-2a95a90ad608Available on FDA.report

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

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

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 (product): 0404-1701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248389sodium fluoride 2.72 % Oral FoamPSNc10af938-0537-2425-e053-2a95a90ad6083
248389sodium fluoride 27.2 MG/ML Oral FoamSCDc10af938-0537-2425-e053-2a95a90ad6083
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSYc10af938-0537-2425-e053-2a95a90ad6083
248389sodium fluoride 2.72 % Oral FoamSYc10af938-0537-2425-e053-2a95a90ad6083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-1701-4400404170144125 g in 1 CANISTER (0404-1701-44) 125 g2021-04-280000-00-00NoNoCurrent