Sodium Fluoride Gel

Product NDC
50268-733
11-digit product format
502680733
Labeler code
50268
Product ID
50268-733_47fc8e5e-ba96-0118-e063-6394a90ad45c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
AvPAK
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-05-09
Substance
SODIUM FLUORIDE
Active strength
5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de973f9c-af34-4977-e053-2995a90a54a0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-733-56Sodium Fluoride Gel1 in 1 CARTONGEL, DENTIFRICE14
50268-733-56Sodium Fluoride Gel56 g in 1 TUBEGEL, DENTIFRICE564

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-733-56GM - Gram50268-733ad98b93b-efb7-48d2-b725-24c03d456f6a12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-733SODIUM FLUORIDE GEL (SODIUM FLUORIDE) GEL, DENTIFRICE [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_de973f9c-af34-4977-e053-2995a90a54a0.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
Sodium Fluoride GelSODIUM FLUORIDEAvPAKde973f9c-af34-4977-e053-2995a90a54a02026-01-09Warnings, Adverse reactionsExact identifier
ndc (product): 50268-733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-733-56502680733561 TUBE in 1 CARTON (50268-733-56) / 56 g in 1 TUBE1 tube2022-05-090000-00-00NoNoCurrent