Home NDC 82976-100 Fluoride Bits
Product NDC 82976-100
11-digit product format 829760100
Labeler code 82976
Product ID 82976-100_28f176f5-cbbd-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 2022-12-06
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 82976-100-00 Fluoride Bits 124 in 1 POUCH TABLET 124 4 82976-100-02 Fluoride Bits 124 in 1 BOTTLE, GLASS TABLET 124 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82976-100 FLUORIDE BITS (SODIUM MONOFLUOROPHOSPHATE 0.76%) TABLET [THE KIND LAB, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241213_eedf13dc-a009-027a-e053-2995a90a8ec8.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 19 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Povi-One POVIDONE-IODINE 10% TOPICAL Elevate Oral Care f5252b4f-5e14-509e-e053-2995a90a6db8 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f199947-bf25-914b-e063-6394a90a8a6f 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f199947-bf28-914b-e063-6394a90a8a6f 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f19a1a7-c234-8d26-e063-6394a90ad7e9 2025-09-18 Warnings Exact identifier application number: M022 McKesson Orasol Gel BENZOCAINE 20% McKesson Medical-Surgical cc8724f4-c482-5e7d-e053-2a95a90a608f 2025-09-09 Warnings Exact identifier application number: M022 MGC Health Drops Sugar Free Lemon Mint MENTHOL Medical Group Care LLC 3d70bca7-e830-e693-e063-6294a90a73f9 2025-08-28 Warnings Exact identifier application number: M022 Exchange Select Drops Sugar Free Lemon Mint MENTHOL Army & Air Force Exchange Service 3d70450f-04ea-1885-e063-6294a90a05bd 2025-08-28 Warnings Exact identifier application number: M022 Ki No Sin CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 21fa2bad-5b8b-8aac-e063-6394a90a9f49 2025-08-27 Warnings Exact identifier application number: M022 R Cos CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 21fa767a-1344-5ed9-e063-6394a90a5fe6 2025-08-27 Warnings Exact identifier application number: M022 Na Mi Cal CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 20cfbcd1-eb13-933c-e063-6294a90a7e59 2025-08-27 Warnings Exact identifier application number: M022 Ki No Sin CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 20cf8f80-c638-4d94-e063-6294a90a5400 2025-08-27 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE SODIUM MONOFLUOROPHOSPHATE Yangzhou Hongshengding Chemical Co.,Ltd. 63a69664-8611-4d69-b871-8d1d5b553e5c 2025-08-18 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE SODIUM CHLORIDE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) f51491d8-12ad-4b1b-a171-c621bfdcc341 2025-08-12 Warnings Exact identifier application number: M022 MGC Health Drops Sugar Free Lemon Mint MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. b9227966-847c-40c3-87f2-8bea3954ec84 2025-08-12 Warnings Exact identifier application number: M022 Exchange Select Drops Sugar Free Lemon Mint MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 5f4b1960-43ac-4c74-9410-210c48bd8a1b 2025-08-12 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 113cdb83-0fdd-40f2-8ee6-b771dca99713 2025-08-12 Warnings Exact identifier application number: M022 CVS Pharmacy Maximum Strength BENZOCAINE CVS Pharmacy 13bf31c1-78e3-459f-9249-b0b6e2c17a13 2025-08-12 Warnings Exact identifier application number: M022 Rexall Maximum Strength BENZOCAINE Rexall 8f6e2780-cfb7-4bef-9b7d-13cb80d8923e 2025-08-12 Warnings Exact identifier application number: M022 Walgreens Maximum Strength BENZOCAINE Walgreens 8f24309d-d393-455a-a9a5-a55344adf36b 2025-08-12 Warnings Exact identifier application number: M022 Oral Anesthetic Liquid BENZOCAINE Meijer, Inc. 0321c480-e150-421d-e063-6294a90ad687 2025-08-12 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82976-100-00 82976010000 124 TABLET in 1 POUCH (82976-100-00) 124 tablet 2022-12-06 0000-00-00 No No Current 82976-100-02 82976010002 124 TABLET in 1 BOTTLE, GLASS (82976-100-02) 124 tablet 2022-12-06 0000-00-00 No No Current