FDA.reportPublic FDA data

Dr. Jen SuperPaste Nano-Hydroxyapatite

Manufacturer
Dr Jen Natural, LLC
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:19

Label at a glance#

ProductDr. Jen SuperPaste Nano-Hydroxyapatite
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 thoroughly, preferably after
each meal or at least twice a day,
or as directed by a dentist or
doctor. Instruct children under 6
years of age in good brushing and
rinsing 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 Methyl Cocoyl
Taurate, Sodium Carboxymethyl -
cellulose, Natural Flavor, Menthol,
Stevia Rebaudiana Leaf Extract,
Citric Acid, Illicium Verum (Anise)
Fruit Extract, Carica Papaya Extract,
Prunus Serotina (Black Cherry) Bark
Extract, Glycyrrhiza Uralensis
(Chinese Licorice) Root Extract,
Mentha Spicata (Spearmint), Mentha
Arvensis (Peppermint), Spirulina
Platensis Powder

Dr. Jen SuperPaste Product Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Jen

Super Paste

TRIPLE CAVITY
PROTECTION

10% NANO-HYDROXYAPATITE,
FLUORIDE & XYLITOL
TOOTHPASTE

3.4 FL. OZ. | 100 ML

DrJenNatural.com

Dr. Jen
St. Paul, MN 55118

357 Box357 Box

357 Tube357 Tube

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84181-357-05Dr. Jen SuperPaste Nano-Hydroxyapatite1 in 1 BOXPASTE, DENTIFRICE12
84181-357-05Dr. Jen SuperPaste Nano-Hydroxyapatite100 mL in 1 TUBEPASTE, DENTIFRICE1002

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84181-35784181-357-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MENTHOLL7T10EIP3AIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STAR ANISE FRUITCK15HA8438IACT
CARICA PAPAYA LEAF66J7636Z2IIACT
GLYCYRRHIZA URALENSIS ROOT42B5YD8F0KIACT
PRUNUS SEROTINA BARK5D48E975HAIACT
SPEARMINTJ7I2T6IV1NIACT
PEPPERMINTV95R5KMY2BIACT
ARTHROSPIRA PLATENSIS9L3TIH1UUEIACT

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 Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC5f08d994-e458-42b2-aa39-e84fca3acf482025-12-05WarningsExact identifier
ndc (package): 84181-357-05
ndc (product): 84181-357
ndc11 (package): 84181035705
spl id: 10ad5ec7-a9c8-446f-acfb-f6164cb450d8
spl set id: 5f08d994-e458-42b2-aa39-e84fca3acf48