FDA.reportPublic FDA data

Kaylaan Mint Toothpaste Tablet

Manufacturer
Kaylaan LLC
Effective date
2021-09-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:21

Label at a glance#

ProductKAYLAAN
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINSTRATION SECTIONDOSAGE & ADMINSTRATION SECTION

WARNINGS SECTION

WARNINGS SECTIONWARNINGS SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTIONINDICATIONS & USAGE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC-KEEP OUT OF REACH OF CHILDREN SECTIONOTC-KEEP OUT OF REACH OF CHILDREN SECTION

OTC - PURPOSE SECTION

OTC - PURPOSE SECTIONOTC - PURPOSE SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82091-112-102023-01-30C16284748780-1f386c64a-405f-0266-e053-dadaa90a7c1aKaylaan Mint Toothpaste Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82091-112-10KAYLAAN74.3 mg in 1 BOX, UNIT-DOSETABLET, CHEWABLE74.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82091-112KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC]2Current NDC, Legacy NDC, 1 package rows20210913_cb6f6566-5fae-4827-e053-2995a90a43a7.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82091-11282091-112-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEVIA LEAF6TC6NN0876IACT
ERYTHRITOLRA96B954X6IACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
XANTHAN GUMTTV12P4NEEIACT
MINTFV98Z8GITPIACT
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM BICARBONATE8MDF5V39QOIACT
MAGNESIUM STEARATE70097M6I30IACT
XYLITOLVCQ006KQ1EIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCc68fd8c7-7ec3-cc3f-e053-2995a90a43952025-01-16WarningsExact identifier
ndc (product): 82091-112
cb6f6566-5faf-4827-e053-2995a90a43a7cb6f6566-5fae-4827-e053-2995a90a43a72021-09-07WarningsExact identifier
spl id: cb6f6566-5faf-4827-e053-2995a90a43a7
spl set id: cb6f6566-5fae-4827-e053-2995a90a43a7

Reported adverse events (FAERS/openFDA)#

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