Home NDC 85215-002 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry
Product NDC 85215-002
11-digit product format 852150002
Labeler code 85215
Product ID 85215-002_3573e1bb-55ac-2f35-e063-6394a90a7fb7
Type HUMAN OTC DRUG
Nonproprietary name Fluoride Anti Caries Toothpaste 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry
Dosage form OINTMENT
Route DENTAL
Labeler WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-19
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 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85215-002-01 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry 65 g in 1 TUBE OINTMENT 65 1 85215-002-02 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry 12 in 1 BOX OINTMENT 12 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85215-002 FLUORIDE ANTI CARIES 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY (FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY) OINTMENT [WORLD DENTISTS ASSOCIATION AMERICA LIMITED] 1 Current NDC, 2 package rows 20250521_3573f149-2af9-4c86-e063-6294a90a7b3f.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 15 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 85215-002-01 85215000201 65 g in 1 TUBE 65 g Historical 85215-002-02 85215000202 12 TUBE in 1 BOX (85215-002-02) / 65 g in 1 TUBE (85215-002-01) 12 tube 2025-05-19 No No Current