FDA.reportPublic FDA data

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
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.76 g/1001

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa433031-7376-0e5b-e053-6394a90a5f75Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82976-101-00Fluoride Bits124 in 1 POUCHTABLET1243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82976-101FLUORIDE BITS (SODIUM MONOFLUOROPHOSPHATE 0.76%) TABLET [THE KIND LAB, INC.]3Current NDC, 1 package rows20241213_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 17 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
application number: M022
Iodent Oral AnalgesicBENZOCAINEUnited Exchange Corp.63902125-f8dc-0ada-e053-2991aa0a7ce52025-10-30WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact identifier
application number: M022
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
application number: M022
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
application number: M022
WinCo Foods Maximum Strength Oral AnalgesicBENZOCAINEWinCo Foods, LLCc22a7726-8c3f-41bf-b852-8456b2be6f932025-10-28WarningsExact identifier
application number: M022
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
application number: M022
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
application number: M022
Meijer Sore ThroatPHENOLMEIJER DISTRIBUTION INC.360f9756-1cd7-41b2-8ee2-9d1bb7234cf12025-10-24WarningsExact identifier
application number: M022
MEIJER SalineNASALMEIJERa5c6d800-078a-4b66-9d4c-cf3c53f5c1382025-10-24WarningsExact identifier
application number: M022
meijer Maximum Strength Sore Throat Fast ReliefPHENOL AND GLYCERINMEIJER DISTRIBUTION INCf1f17aab-7ea7-4dac-a854-48b4b560ec4f2025-10-24WarningsExact identifier
application number: M022
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and CoughMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.6b1a50d0-be54-4fcb-b5e2-b47abf3555c02025-10-23WarningsExact identifier
application number: M022
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
application number: M022
Boka SensitivePOTASSIUM NITRATEKaraka LLC40be9fab-53db-c67a-e063-6394a90a48cb2025-10-23WarningsExact identifier
application number: M022
Canker Care PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.1ec960db-52d5-4d99-a7f7-a2e538d287242025-10-20WarningsExact identifier
application number: M022
meijer Sensitive EXTRA WHITENINGPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bbcffb88-0bd4-4883-bb83-0b7a1428ad122025-10-20WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82976-101-0082976010100124 TABLET in 1 POUCH (82976-101-00) 124 tablet2023-05-19NoNoCurrent