Home NDC 85215-001 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength SODIUM FLUORIDE .25 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85215-001-01 Bubble Gum Flavor For Kids 25g 50g 25 g in 1 TUBE OINTMENT 25 1 85215-001-02 Bubble Gum Flavor For Kids 25g 50g 50 g in 1 TUBE OINTMENT 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85215-001 BUBBLE GUM FLAVOR FOR KIDS 25G 50G (BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G) OINTMENT [WORLD DENTISTS ASSOCIATION AMERICA LIMITED] 1 Current NDC, 2 package rows 20250521_354c1eda-ec5b-a8c7-e063-6294a90a871d.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 9 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85215-001-01 85215000101 25 g in 1 TUBE (85215-001-01) 25 g 2025-05-17 No No Current 85215-001-02 85215000102 50 g in 1 TUBE (85215-001-02) 50 g 2025-05-17 No No Current