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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health AdvantageCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyddcd56fe-25d6-8195-e053-2a95a90a575a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dc1f31-625d-a032-e053-2995a90a730d2026-01-08WarningsExact identifier
application number: M022
Crest Pro Health Gum plus Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc598a4ab-5981-0068-e053-2a95a90af4fa2026-01-08WarningsExact identifier
application number: M022
Oral B Gum Detoxify Special Care RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dcdde4-5542-1f87-e053-2995a90a261c2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Fresh MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company62991165-ec81-48a8-e053-2991aa0a54f32026-01-08WarningsExact identifier
application number: M022
Crest Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company6287bc3e-8b05-45d3-e053-2991aa0aaa102026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company8867d791-7e93-4f39-aaaf-bfbee8296fd92026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
application number: M022
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
application number: M022
Scope Icy BlastCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company164ed151-01d3-021a-e063-6294a90a0e512026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Advanced Enamel CareSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1660e7d7-5b8d-8aba-e063-6294a90a50d82026-01-08WarningsExact identifier
application number: M022
Crest Deep Cleanse Germ TreatmentCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company2d6b15d4-7827-ec2f-e063-6294a90a82c82026-01-08WarningsExact identifier
application number: M022
Crest Scope OriginalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company21eed451-9368-146c-e063-6294a90af62b2026-01-08WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
HEB Extra WhiteningFLUORIDEHEBb76c3591-6383-4661-b3db-7a56b11202f72026-01-08WarningsExact 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