FDA.reportPublic FDA data

Emmi-dent Fresh

Manufacturer
EMAG AG | Weckerle Cosmetics
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:42

Label at a glance#

ProductEmmi-dent Fresh
Active ingredientSodium Fluoride
Label structure10 sections

Dosage and administration

* adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist * do not swallow * to minimize swallowing use a pea-sized amount in children unter 6 * supervise children's dental cleaning until good habits are established * children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.199% (0.11% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 yrs. of age.

If more than used for dental cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children unter 6
  • supervise children's dental cleaning until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, propylene glycol, tetrapotassium pyrophosphate, xanthan gum, sodium C-14-16 olefin sulfonate, aroma, mentha arvenis leaf oil, titanium dioxide, sodium methyl paraben, sodium saccharin, allantoin, chamomilla recutita (matricaria) flower extract, salvia triloba leaf extract

Questions?

OTC - QUESTIONS SECTION

1-833-682-8902

PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

emmi® DENT

FRESH
PROFESSIONAL

emmi® DENT

100% ULTRASOUND

Ultrasound Toothpaste

Made in Germany

Ideal

100% Ultraschall®

Made by EMAG Germany

PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton
PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235783sodium fluoride 0.2 % ToothpastePSN4
1235783sodium fluoride 0.002 MG/MG ToothpasteSCD4
1235783sodium fluoride 0.2 % ToothpasteSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63956-004-012024-12-12C16284748780-11030e365-05ea-111a-e063-dadaa90a10e2Emmi ® -dent Fresh
63956-004-012024-07-30C16284748780-11030e365-05ea-111a-e063-dadaa90a10e2Emmi ® -dent Fresh
63956-004-012024-01-30C16284748780-11030e365-05ea-111a-e063-dadaa90a10e2Emmi ® -dent Fresh

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63956-004-01Emmi-dent Fresh75 mL in 1 TUBEPASTE, DENTIFRICE754
63956-004-01Emmi-dent Fresh1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63956-004EMMI-DENT FRESH (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]4Legacy NDC, 2 package rows20241215_1986a759-7dec-4287-884b-556cf314679e.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63956-00463956-004-01

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
Water059QF0KO0RIACT
Sorbitol506T60A25RIACT
Hydrated SilicaY6O7T4G8P9IACT
Propylene Glycol6DC9Q167V3IACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
Xanthan GumTTV12P4NEEIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
Mentha Arvensis Leaf oil1AEY1M553NIACT
Titanium Dioxide15FIX9V2JPIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
Allantoin344S277G0ZIACT
CHAMOMILEFGL3685T2XIACT
THREE-LOBE SAGE3V97D33N0KIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT

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
e154bd01-f2ab-4f60-a2a9-aa09d3de88111986a759-7dec-4287-884b-556cf314679e2024-12-03WarningsExact identifier
spl id: e154bd01-f2ab-4f60-a2a9-aa09d3de8811
spl set id: 1986a759-7dec-4287-884b-556cf314679e

Reported adverse events (FAERS/openFDA)#

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