Schmidts

Manufacturer
Schmidt's Naturals
Effective date
2019-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:44

Label at a glance#

ProductSchmidts WATERMELON and STRAWBERRY KIDS TOOTH AND MOUTH
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

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 Physician. Children 2 to 6 years of age:    Instruct children under 6 years of age in good brushing and rinsing methods (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate (0.77%)

(0.10% w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use 

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. 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 Physician.

Children 2 to 6 years of age:   

Instruct children under 6 years of age in good brushing and rinsing methods (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a Dentist or Physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sodium Methyl Cocoyl Taurate, Natural Flavor, Xanthan Gum, Cocos Nucifera (Coconut) Oil, Stevia Rebaudiana Leaf/Stem Powder, Aloe Barbadensis Leaf Extract, Magnolia Acuminata (Blue Magnolia) Bark Extract, Lycium Barbarum (Goji Berry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E, Sunflower Derived), Sodium Bicarbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate.

Questions

OTC - QUESTIONS SECTION

855.866.9748

SPL UNCLASSIFIED SECTION

CAVITY PROTECTION

SLS FREE | TRICLOSAN FREE | PEG FREE

FLUORIDE TOOTHPASTE FOR CAVITY PREVENTION

√DYE FREE  √NO ARTIFICIAL FLAVORS 

CERTIFIED VEGAN & CRUELTY-FREE.

DIST. BY ©SCHMIDT'S | SCHMIDTS.COM
PORTLAND, OR 97209, USA

Packaging 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72916-310-052021-01-29C16284748780-1ba0f9c33-45ae-a910-e053-dadaa90a0b85Schmidt's™-WATERMELON+STRAWBERRY KIDS TOOTH+MOUTH PASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72916-310-05SchmidtsWATERMELON and STRAWBERRY KIDS TOOTH AND MOUTH133 g in 1 TUBEPASTE, DENTIFRICE1331
72916-310-05SchmidtsWATERMELON and STRAWBERRY KIDS TOOTH AND MOUTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72916-310SCHMIDTS WATERMELON AND STRAWBERRY KIDS TOOTH AND MOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SCHMIDT'S NATURALS]1Legacy NDC, 2 package rows20190621_4e83c19d-8493-4d01-83d6-4cd7ee61e812.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72916-31072916-310-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
f3437a71-22fa-44a2-8b74-9456be0c43a74e83c19d-8493-4d01-83d6-4cd7ee61e8122019-06-12WarningsExact identifier
spl id: f3437a71-22fa-44a2-8b74-9456be0c43a7
spl set id: 4e83c19d-8493-4d01-83d6-4cd7ee61e812

Reported adverse events (FAERS/openFDA)#

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