FDA.reportPublic FDA data

Fluoride Bits

Manufacturer
The Kind Lab, Inc.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:38

Label at a glance#

ProductFluoride Bits
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76 % (0.14% w/w fluoride ion)

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Helps protect against dental cavities

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away. Keep away from pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 yrs of age

DOSAGE & ADMINISTRATION SECTION

Adult:

Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or atleast twice daily or as directed by a dentist or physician. Rinse after using. Do not swallow.

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

OTHER SAFETY INFORMATION

Store at room temperature and in a dry place.

OTC - QUESTIONS SECTION

BiteToothpaste.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82976-100-0082976-100-0082976-100-0282976-100-02

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82976-10082976-100-02, 82976-100-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
MENTHOLL7T10EIP3AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
CALCIUM CARBONATEH0G9379FGKIACT
PEPPERMINTV95R5KMY2BIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ZINC CITRATEK72I3DEX9BIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
GUAR GUME89I1637KEIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
ndc (package): 82976-100-00
ndc (package): 82976-100-02
ndc (product): 82976-100
ndc11 (package): 82976010000
ndc11 (package): 82976010002
spl id: 28f176f5-cbbd-b69a-e063-6394a90aa893
spl set id: eedf13dc-a009-027a-e053-2995a90a8ec8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.