Home NDC 82913-005 AutoBrush bubblegum
Product NDC 82913-005
11-digit product format 829130005
Labeler code 82913
Product ID 82913-005_49f005e2-f3a4-6594-e063-6294a90a7bcd
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL
Route ORAL
Labeler Lander Enterprises, LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-01
Substance SODIUM FLUORIDE
Active strength .243 g/100g
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 AutoBrush bubblegum
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .243 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 Internal RxNorm 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 82913-005-01 AutoBrush bubblegum 100 g in 1 TUBE GEL 100 1 82913-005-01 AutoBrush bubblegum 1 in 1 BOX GEL 1 1
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 33 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82913-005-01 82913000501 1 TUBE in 1 BOX (82913-005-01) / 100 g in 1 TUBE 1 tube 2026-01-01 No No Current