FDA.reportPublic FDA data

Kaylaan Strawberry Toothpaste Tablet Refill

Manufacturer
Kaylaan LLC
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:51:48

Label at a glance#

ProductKAYLAAN
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DOSAGE and ADMINISTRATION SECTIONDOSAGE and ADMINISTRATION SECTION

WARNINGS SECTION

WARNINGS SECTIONWARNINGS SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

INDICATIONS & USAGE SECTION

INDICATION and USAGEINDICATION and USAGE

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82091-113-10KAYLAAN74.3 mg in 1 BOTTLE, UNIT-DOSETABLET, CHEWABLE74.35

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]5Current NDC, Legacy NDC, 1 package rows20250112_2b494372-de59-e462-e063-6294a90a08da.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
82091-11382091-113-10

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

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
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
ndc (package): 82091-113-10
ndc (product): 82091-113
ndc11 (package): 82091011310
spl id: 2b4940da-237f-e433-e063-6294a90a47f0
spl set id: 2b494372-de59-e462-e063-6294a90a08da

Reported adverse events (FAERS/openFDA)#

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