FDA.reportPublic FDA data

Kaylaan Strawberry Toothpaste Tablet Refill

Manufacturer
Kaylaan LLC
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:14

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
82091-113-012025-01-30C16284748780-12cef2736-70c4-d83d-e063-dadaa90ab31fKaylaan Strawberry Toothpaste Tablet Refill

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82091-113-01KAYLAAN74.3 mg in 1 BOTTLE, UNIT-DOSETABLET, CHEWABLE74.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82091-113KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC]4Current NDC, Legacy NDC, 1 package rows20230113_cb7d4735-42a0-3555-e053-2a95a90a5bc8.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
82091-11382091-113-01

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
SODIUM FLUORIDE8ZYQ1474W7ACTIM
STEVIA LEAF6TC6NN0876IACT
ERYTHRITOLRA96B954X6IACT
XYLITOLVCQ006KQ1EIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM CARBONATEH0G9379FGKIACT
MAGNESIUM STEARATE70097M6I30IACT
STRAWBERRY4J2TY8Y81VIACT

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 LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
ndc (product): 82091-113
f1ed1ec4-fd79-a448-e053-2995a90ab6facb7d4735-42a0-3555-e053-2a95a90a5bc82023-01-12WarningsExact identifier
spl id: f1ed1ec4-fd79-a448-e053-2995a90ab6fa
spl set id: cb7d4735-42a0-3555-e053-2a95a90a5bc8

Reported adverse events (FAERS/openFDA)#

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