FDA.reportPublic FDA data

Bubble Gum Flavor For Kids 25g 50g

Product NDC
85215-001
11-digit product format
852150001
Labeler code
85215
Product ID
85215-001_354c0e4d-45af-b189-e063-6394a90a96e9
Type
HUMAN OTC DRUG
Nonproprietary name
Bubble Gum Flavor Toothpaste For Kids 25g 50g
Dosage form
OINTMENT
Route
DENTAL
Labeler
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-17
Substance
SODIUM FLUORIDE
Active strength
.25 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
Bubble Gum Flavor For Kids 25g 50g
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.25 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85215-001-01Bubble Gum Flavor For Kids 25g 50g25 g in 1 TUBEOINTMENT251
85215-001-02Bubble Gum Flavor For Kids 25g 50g50 g in 1 TUBEOINTMENT501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85215-001BUBBLE GUM FLAVOR FOR KIDS 25G 50G (BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G) OINTMENT [WORLD DENTISTS ASSOCIATION AMERICA LIMITED]1Current NDC, 2 package rows20250521_354c1eda-ec5b-a8c7-e063-6294a90a871d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85215-001-018521500010125 g in 1 TUBE (85215-001-01) 25 g2025-05-17NoNoHistorical
85215-001-028521500010250 g in 1 TUBE (85215-001-02) 50 g2025-05-17NoNoHistorical