Home NDC 82976-101 Fluoride Bits
Product NDC 82976-101
11-digit product format 829760101
Labeler code 82976
Product ID 82976-101_28f176f5-cbbc-b69a-e063-6394a90aa893
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate 0.76%
Dosage form TABLET
Route DENTAL
Labeler The Kind Lab, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-19
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .76 g/1001
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 Bits
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .76 g/1001
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q 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 82976-101-00 Fluoride Bits 124 in 1 POUCH TABLET 124 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82976-101 FLUORIDE BITS (SODIUM MONOFLUOROPHOSPHATE 0.76%) TABLET [THE KIND LAB, INC.] 3 Current NDC, 1 package rows 20241213_fa433031-7376-0e5b-e053-6394a90a5f75.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 28 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 82976-101-00 82976010100 124 TABLET in 1 POUCH (82976-101-00) 124 tablet 2023-05-19 No No Current