FDA.reportPublic FDA data

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
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
eedf13dc-a009-027a-e053-2995a90a8ec8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82976-100-00Fluoride Bits124 in 1 POUCHTABLET1244
82976-100-02Fluoride Bits124 in 1 BOTTLE, GLASSTABLET1244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82976-100FLUORIDE BITS (SODIUM MONOFLUOROPHOSPHATE 0.76%) TABLET [THE KIND LAB, INC.]4Current NDC, Legacy NDC, 2 package rows20241213_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 18 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
application number: M022
DuoCare Clinical Oral RinseCETYLPYRIDINIUM CHLORIDEMedline Industries, LP98e61cd5-7e29-7066-e053-2a95a90afa212025-10-10WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd40b756b7-ce1b-6482-e063-6294a90a04252025-10-09WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEGil Pharmaceutical Corp85053391-8d71-ab4f-e053-2991aa0a7e082025-10-09WarningsExact identifier
application number: M022
Listerine Gum Therapy Mouthwash Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC40a0bdf3-1698-1449-e063-6394a90ab13d2025-10-08WarningsExact identifier
application number: M022
Kalaya Breath RefreshMOUTHWASHAvaria Health and Beauty Corp750e99ff-72e4-3c2f-e053-2a91aa0ad5a02025-10-08WarningsExact identifier
application number: M022
Trader JoesSODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%TRADER JOE'S COMPANY159abeba-6da2-2643-e063-6394a90a730d2025-10-08WarningsExact identifier
application number: M022
Family Wellness Oral Pain ReliefBENZOCAINE 20%FAMILY DOLLAR SERVICES INC105d87d6-9147-43d4-e063-6394a90a57ee2025-10-08WarningsExact identifier
application number: M022
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
application number: M022
Mouth Sore Relief Professional StrengthBENZOCAINECVS Pharmacy1b7209f6-8368-47fa-8df2-b049613b8c1b2025-09-30WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEFamily Dollar (FAMILY WELLNESS)9db73da2-5b70-41e6-bcf9-caa7f11420242025-09-29WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic LiquidCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47d7e1-b6ae-efd1-e063-6394a90a46022025-09-27WarningsExact identifier
application number: M022
Chloraseptic Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.d5d62f7a-8f92-4d42-a2fb-691f896f72fc2025-09-26WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEDextrum Laboratories Inc.3fa233dc-156c-1e95-e063-6294a90a8bbd2025-09-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEDextrum Laboratories Inc.cb027ab8-4175-4cc0-a73e-991dfb113df92025-09-23WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
application number: M022
Dental ReliefBENZOCAINECintas Corporation0f40f775-797e-43cf-88c9-00eea666494f2025-09-23WarningsExact identifier
application number: M022
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
application number: M022
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
application number: M022
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82976-100-0082976010000124 TABLET in 1 POUCH (82976-100-00) 124 tablet2022-12-060000-00-00NoNoCurrent
82976-100-0282976010002124 TABLET in 1 BOTTLE, GLASS (82976-100-02) 124 tablet2022-12-060000-00-00NoNoCurrent