FDA.reportPublic FDA data

Lanisty ToothpasteTablets

Manufacturer
COMFMET LIMITED
Effective date
2024-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:46

Label at a glance#

ProductLanisty ToothpasteTablets
Active ingredientSODIUM BICARBONATE, MENTHOL, LACTOBACILLUS ACIDOPHILUS
Label structure14 sections

Indications and uses

Keeps teeth white and strong

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Bicarbonate - (Baking Soda) 22%
Menthol Formylethylamine - (Menthol) 9%
Lactobacillus - (Lactobacillus) 1%

Purpose

OTC - PURPOSE SECTION

Keeps teeth white and strong.Keeps your mouth clean.Refreshes your mouth.Prevents tooth decay and elimina-tes bad breath.Enhances the aesthetic effectPrevention of gingivitis,periodontitis (pyorrhea alveolaris)Prevention of periodontal diseasePrevention of gum diseaseRemoval of plaque (Anti-plaque)

Uses

INDICATIONS & USAGE SECTION

Keeps teeth white and strong

Warnings

WARNINGS SECTION

Children need to be accompanied by a guadian

Do not use

OTC - DO NOT USE SECTION

if this toothpaste causes anydamage to the gums or mouth,discontinue use and consultyour doctor or dentist.

When Using

OTC - WHEN USING SECTION

Avoid direct ingestion

Stop Use

OTC - STOP USE SECTION

if this toothpaste causes anydamage to the gums or mouth,discontinue use and consultyour doctor or dentist.

Ask Doctor

OTC - ASK DOCTOR SECTION

if a child under 6 years of ageswallows a large amount, imme-diately consult your doctor ordentist.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help orcontact Poison Control Center right away.

INDICATIONS & USAGE SECTION

1.Grab up a tablet and plance it your mouth
2.Chew your tablet until fully dissolvrf.
3.Brush with a wet toothbrushfor two minutes twice a day

INACTIVE INGREDIENT SECTION

Maltodextrin
Sodium Carbonate
Light Calcium Carbonate
Essence
Sodium Lauryl Sulfate
Xanthan Gum
Trichlorogalactose
Bioactive Glass
Cocos Nucifera Shell Powder

Questions

OTC - QUESTIONS SECTION

Email: commet515@gmail.com

DOSAGE & ADMINISTRATION SECTION

Place tablets in your mouth.
Chew until it foams.
Brush your teeth as usual. Use twice daily.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

toothpastetoothpaste

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84766-0001-22025-07-29C16284748780-13b156c62-343b-fb37-e063-e6dba90a4e0722c25b85-809f-7d84-e063-6394a90afe93

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84766-0001-2Lanisty ToothpasteTablets50 g in 1 BOTTLETABLET503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84766-0001LANISTY TOOTHPASTETABLETS TABLET [COMFMET LIMITED]31 package rows20241008_22c25b85-809f-7d84-e063-6394a90afe93.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
84766-000184766-0001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BICARBONATE8MDF5V39QOACTIB
CALCIUM CARBONATEH0G9379FGKIACT
XANTHAN GUMTTV12P4NEEIACT
EPIRUBICIN HYDROCHLORIDE22966TX7J5IACT
DIHYDROXYALUMINUM SODIUM CARBONATE84H8Z9550JIACT
VANILLAQ74T35078HIACT
MENTHOLL7T10EIP3AACTIB
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCONUT SHELL7O4218UHJ4IACT
LACTOBACILLUS ACIDOPHILUS1PRR1V42V5ACTIB

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
23da7216-e3e3-d915-e063-6394a90a21de22c25b85-809f-7d84-e063-6394a90afe932024-10-06WarningsExact identifier
spl id: 23da7216-e3e3-d915-e063-6394a90a21de
spl set id: 22c25b85-809f-7d84-e063-6394a90afe93

Reported adverse events (FAERS/openFDA)#

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