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 39 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORCA Pain Reliever Putty with Menthol	MENTHOL	ORCA Products, LLC	188cb01a-3d0f-43d9-983e-6475c0c5b06e	2023-11-10	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	33fbdbc7-e10d-4181-926f-9b591b5b07e3	2023-11-08	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0d2c8c0c-4c72-4400-b3b5-ed578fa35167	2023-11-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Degasa, S.A. de C.V.	45ac0275-4c68-3897-e054-00144ff8d46c	2023-11-05	Warnings	Exact identifier application number: M022
Oral Pain Relief	BENZOCAINE	GERI-CARE PHARMACEUTICAL CORP	d294a39e-55f4-272d-e053-2995a90ab7f7	2023-10-31	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	e10c45e6-d37f-4650-b3e5-07719cc0ea49	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	886d949b-8db1-499c-a277-174f8bc29f34	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	fc8194af-2e77-4ad1-ae75-461dce3ed604	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	baf7d184-07ed-4491-a1fc-9a377b4b0110	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	033034af-c86c-4dbf-90eb-009c117024c6	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	658ada18-2334-4b4e-b08e-702fa127aa14	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	cad932e5-8d7f-4f20-b1c2-febd328152f0	2023-10-11	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	2c9519ab-320d-49da-9deb-97a6168fb088	2023-10-10	Warnings	Exact identifier application number: M022
Ioline	BENZOCAINE	Dharma Research, Inc.	b862c974-c024-42c3-986e-b65069437c7b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	651ea978-081d-4c59-b177-6049a69d9415	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	db763237-2910-45b9-be72-da092edc951b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	34316f93-10b4-41cc-8654-625283f0044c	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	142a8824-657e-492a-8e5a-b15eb73383c9	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	414cbec9-94e2-4bca-908b-1e79f8db0b27	2023-10-10	Warnings	Exact identifier application number: M022
Sore throat cherry	PHENOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de634cf1-ed39-4d8a-8855-006c69b7aee9	2023-10-10	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