FDA.reportPublic FDA data

Kindfill

Manufacturer
By Humankind Inc | Make USA LLC | Denttabs GmbH
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:02

Label at a glance#

ProductKindfill
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years of age and older; chew one tablet until crushed, wet toothbrush, brush for 2 minutes. Spit out. Do not swallow the tablet. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride .62mg (28 mg flouride ion)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

  • When using this product, if irritation or sensitivity occurs discontinue use.
  • Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

OTC - WHEN USING SECTION

When using this product, if irritation or sensitivity occurs discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older; chew one tablet until crushed, wet toothbrush, brush for 2 minutes. Spit out.
  • Do not swallow the tablet.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 in Each Box NDC:80487-111-1160 in Each Box NDC:80487-111-1160 in Each Box NDC:80487-112-11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80487-112-112025-11-01C16284748780-1e4f33bdf-abc3-d8a0-e053-dadaa90a6e4eBYHUMANKIND-MAKE USA: Kindfill Dental Tabs
80487-112-112022-07-29C16284748780-1e4f33bdf-abc3-d8a0-e053-dadaa90a6e4eBYHUMANKIND-MAKE USA: Kindfill Dental Tabs

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80487-112KINDFILL (MINT TOOTHPASTE TABLETS) TABLET, CHEWABLE [BY HUMANKIND INC]2Legacy NDC20210211_baeb873e-e8cc-22cb-e053-2995a90ae0a0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80487-11280487-112-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEVIA LEAF6TC6NN0876IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINTFV98Z8GITPIACT
MENTHOL, (+)-C6B1OE8P3WIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAUROYL GLUTAMATENCX1UU2D33IACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
42756a0a-f01b-81d3-e063-6294a90a8c89baeb873e-e8cc-22cb-e053-2995a90ae0a02025-10-31WarningsExact identifier
spl set id: baeb873e-e8cc-22cb-e053-2995a90ae0a0

Reported adverse events (FAERS/openFDA)#

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