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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fa433031-7376-0e5b-e053-6394a90a5f75	Available on FDA.report

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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

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