FDA.reportPublic FDA data

Dr. Jen SuperPaste Ortho

Manufacturer
Dr Jen Natural, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:19:58

Label at a glance#

ProductDr. Jen SuperPaste Ortho
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredient
Sodium Fluoride 0.22%

OTC - PURPOSE SECTION

Purpose:
Sodium Fluoride - Anticavity

INDICATIONS & USAGE SECTION

Use: Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings:

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children
2 years of age and older: Brush
teeth twice a day with a pea size amount for two minutes. Spit out excess and do not rinse. Wait 30 minutes before eating or drinking, or as directed by a dentist or
doctor. Instruct children under 6
years of age in good brushing and spitting habits (to minimize
swallowing). Supervise children as
necessary until capable of using
without supervision. Children under
2 years of age: Consult a dentist or
doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Glycerin,
Hydrated Silica, Xylitol, Nano-Hydroxyapatite,
Calcium Carbonate, Sodium Carboxy-
methylcellulose, Natural Flavor, Menthol,
Sodium Methyl Cocoyl Taurate, Stevia
Rebaudiana Leaf Extract, Citric Acid, Aloe
Barbadensis (Aloe Vera), Illicium verum (Anise)
Extract, Papaya Extract, Prunus Serotina (Black
Cherry) Extract, Glycyrrhiza Uralensis (Chinese
Licorice) Root Extract, Mentha Spicata
(Spearmint), Mentha Arvensis (Peppermint),
Vitamin D3, Vitamin k2, Calendula

Dr. Jen SuperPaste Product Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

++++++++++++++++++++++++++++++++

​DR.JEN

SP

Super

Paste

ORTHO

10% PREMIUM
NANO-HYDROXYAPATITE,
FLUORIDE & XYLITOL
TOOTHPASTE
___________
Cool Mint
___________

3.4 FL. OZ. | 100 ML

​DRJENNATURAL.COM

Dr. Jen
St. Paul, MN 55118

ortho imgortho img

cartoncarton

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199284212046GTIN-13: 0199284212046
EAN-13: 0199284212046
GTIN-12: 199284212046
UPC-A: 199284212046
GTIN storage (14 digits): 00199284212046		ortho super.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84181-359-09Dr. Jen SuperPaste Ortho1 in 1 BOXPASTE, DENTIFRICE11
84181-359-09Dr. Jen SuperPaste Ortho100 mL in 1 TUBEPASTE, DENTIFRICE1001

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
84181-35984181-359-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CALCIUM CARBONATEH0G9379FGKIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MENTHOLL7T10EIP3AIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
STEVIA REBAUDIANA LEAF6TC6NN0876IACT
CITRIC ACID2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
ILLICIUM VERUM WHOLE52JDS841PXIACT
PAPAYAKU94FIY6JBIACT
BLACK CHERRYA77056YJ4KIACT
GLYCYRRHIZA URALENSIS ROOT42B5YD8F0KIACT
SPEARMINTJ7I2T6IV1NIACT
PEPPERMINTV95R5KMY2BIACT
CHOLECALCIFEROL1C6V77QF41IACT
MENAQUINONE 671ANL51TLAIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT

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
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
ndc (package): 84181-359-09
ndc (product): 84181-359
ndc11 (package): 84181035909
spl id: 22708540-3c27-4dc6-8720-9486b752eb7c
spl set id: 9dd248bf-9488-43cd-a041-e8315a05ce5d

Reported adverse events (FAERS/openFDA)#

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