FDA.reportPublic FDA data

Linhart

Manufacturer
Linhart Inc
Effective date
2021-03-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:07

Label at a glance#

ProductLinhart
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

Aids in the prevention of tooth decay

Dosage and administration

Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount. Supervise children as necessary until capable of using without supervision. Chlidren under 2 years of age: Consult a dentist ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.25%

Purpose 

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of tooth decay

Warnings

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison control center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Chlidren under 2 years of age: Consult a dentist or doctor.

Inactive ingredients 

INACTIVE INGREDIENT SECTION

Sorbitol, Water (purified), Hydrated Silica, Xylitol, Glycerin, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum, Disodium Phosphate, Aloe Barbadenias Leaf Juice, Allantoin, Sodium Saccharin, Theobromine, Bisabolol

Principal Primary Panel - Carton 3.5oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Primary Panel - Carton 3.5ozPrincipal Primary Panel - Carton 3.5oz

LINHART with Linamel

Fluoride Toothpaste

NET WT 3.5oz(99g)

Principal Primary Panel - Carton 3.5ozPrincipal Primary Panel - Carton 3.5oz

Principal Primary Panel - Tube 3.5oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Primary Panel - Tube 3.5ozPrincipal Primary Panel - Tube 3.5oz

LINHART with Linamel

Fluoride Toothpaste

NET WT 3.5oz (99g)

Principal Primary Panel - Tube 3.5ozPrincipal Primary Panel - Tube 3.5oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044547sodium fluoride 0.25 % ToothpastePSN2
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD2
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY2
1044547sodium fluoride 0.25 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70926-100-342023-01-30C16284748780-1ba0f9c33-242b-a910-e053-dadaa90a0b85937d0a02-2ed7-4207-9bbe-2b8017815d68
70926-100-642023-01-30C16284748780-1ba0f9c33-242b-a910-e053-dadaa90a0b85937d0a02-2ed7-4207-9bbe-2b8017815d68
70926-100-642021-03-22C16284748780-1ba0f9c33-242b-a910-e053-dadaa90a0b85937d0a02-2ed7-4207-9bbe-2b8017815d68
70926-100-642021-01-29C16284748780-1ba0f9c33-242b-a910-e053-dadaa90a0b85937d0a02-2ed7-4207-9bbe-2b8017815d68

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70926-100-34Linhart1 in 1 CARTONPASTE, DENTIFRICE12
70926-100-34Linhart28 g in 1 TUBEPASTE, DENTIFRICE282
70926-100-64Linhart1 in 1 CARTONPASTE, DENTIFRICE12
70926-100-64Linhart99 g in 1 TUBEPASTE, DENTIFRICE992

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70926-100LINHART (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [LINHART INC]2Legacy NDC, 4 package rows20210324_937d0a02-2ed7-4207-9bbe-2b8017815d68.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70926-10070926-100-64, 70926-100-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
THEOBROMINEOBD445WZ5PIACT

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
58a832be-5feb-47c7-badd-0a59c10399cc937d0a02-2ed7-4207-9bbe-2b8017815d682021-03-22WarningsExact identifier
spl id: 58a832be-5feb-47c7-badd-0a59c10399cc
spl set id: 937d0a02-2ed7-4207-9bbe-2b8017815d68

Reported adverse events (FAERS/openFDA)#

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