Home NDC 87053-005 Prime Tooth Care Mango Smoothie
Product NDC 87053-005
11-digit product format 870530005
Labeler code 87053
Product ID 87053-005_47f51ae4-adb0-1f0d-e063-6294a90a83c1
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form OINTMENT
Route DENTAL
Labeler Prime Tooth Care LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-31
Substance SODIUM FLUORIDE
Active strength 2.5 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Prime Tooth Care Mango Smoothie
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.5 mg/g
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 87053-005-00 Prime Tooth Care Mango Smoothie 1 in 1 BOX OINTMENT 1 2 87053-005-00 Prime Tooth Care Mango Smoothie 65 g in 1 TUBE OINTMENT 65 2
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 5 of 50 · 995 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87053-005-00 87053000500 1 TUBE in 1 BOX (87053-005-00) / 65 g in 1 TUBE 1 tube 2025-08-31 No No Current