Schmidts

Manufacturer
Schmidt's Naturals
Effective date
2019-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:45

Label at a glance#

ProductSchmidts ACTIVATED CHARCOAL WITH WONDERMINT 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 a Denti...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.81%
(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, Natural Flavor, Sodium Methyl Cocoyl Taurate, Xanthan Gum, Magnolia Acuminata (Magnolia Bark) Extract, Lycium Barbarum (Goji Berry) Extract, Punica Granatum (Pomegranate) Seed Extract, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Charcoal Powder, Mixed Tocopherols (Sunflower-derived), Stevia Rebaudiana Leaf/Stem Extract, Sodium Bicarbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Coenzyme Q10, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate.

Questions:

OTC - QUESTIONS SECTION

855.866.9748

SPL UNCLASSIFIED SECTION

CAVITY PROTECTION

TOOTHPASTE FOR CAVITY PREVENTION

WITH VITAMIN E AND BOTANICAL EXTRACTS

WITH FLUORIDE | SLS FREE | NO ARTIFICIAL FLAVORS

√ PEG FREE √ DYE FREE √ TRICLOSAN FREE

CERTIFIED VEGAN & CRUELTY-FREE.

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048117sodium monofluorophosphate 0.8 % ToothpastePSN1
1048117sodium monofluorophosphate 0.008 MG/MG ToothpasteSCD1
1048117sodium monofluorophosphate 0.0081 MG/MG ToothpasteSY1
1048117sodium monofluorophosphate 0.8 % 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
72916-112-052021-01-29C16284748780-1ba0f9c33-59e8-a910-e053-dadaa90a0b85Schmidt's™-ACTIVATED CHARCOAL WITH WONDERMINT ® TOOTH+MOUTH PASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72916-112-05SchmidtsACTIVATED CHARCOAL WITH WONDERMINT TOOTH AND MOUTH133 g in 1 TUBEPASTE, DENTIFRICE1331
72916-112-05SchmidtsACTIVATED CHARCOAL WITH WONDERMINT TOOTH AND MOUTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72916-112SCHMIDTS ACTIVATED CHARCOAL WITH WONDERMINT TOOTH AND MOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SCHMIDT'S NATURALS]1Legacy NDC, 2 package rows20190621_a817b92d-e0e2-4106-b951-2aa3a363ced6.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72916-11272916-112-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
7b4ce656-4b85-46aa-a5ba-a36c6e0d168aa817b92d-e0e2-4106-b951-2aa3a363ced62019-06-14WarningsExact identifier
spl id: 7b4ce656-4b85-46aa-a5ba-a36c6e0d168a
spl set id: a817b92d-e0e2-4106-b951-2aa3a363ced6

Reported adverse events (FAERS/openFDA)#

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