FDA.reportPublic FDA data

Dr. Jen SuperPaste Perio

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 01:19:57

Label at a glance#

ProductDr. Jen SuperPaste Perio
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTHER SAFETY INFORMATION

IMPORTANT:

Read directions for proper use.

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:

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.

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: Glycerin, Water,
Hydrated Silica, Xylitol, Nano-Hydroxy apatite,
Cellulose Gum, Spearmint Flavor, Menthol
Crystal, Stevia Rebaudiana Leaf Extract, Citric
Acid, Aloe Barbadensis (Aloe Vera), Illicium
verun (Anise) Extract, Papaya Extract, Prunus
Serotina (Black Cherry) Extract, Glycyrrhiza
Uralensis, (Chinese Licorice) Root Extract,
Mentha Spicata (Spearmint), Mentha Arvensis
(Peppermint), Vitamin K2, Vitamin D3,
Calendula

Dr. Jen SuperPaste Perio Product Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DR. JEN
SP


Super
Paste

PERIO

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

3.4 FL. OZ. | 100 ML
DrJenNatural.com
Dr. Jen
St. Paul, MN 55118

Carton

81481 Perio Box81481 Perio Box

Tube

81481 Perio Tube81481 Perio Tube

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

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
84181-358-08Dr. Jen SuperPaste Perio100 mL in 1 TUBEPASTE, DENTIFRICE1001
84181-358-08Dr. Jen SuperPaste Perio1 in 1 CARTONPASTE, DENTIFRICE11

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
84181-35884181-358-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
CELLULOSE GUMK679OBS311IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
STEVIA REBAUDIANA LEAF6TC6NN0876IACT
CITRIC ACID2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
ILLICIUM VERUM WHOLE52JDS841PXIACT
PAPAYAKU94FIY6JBIACT
BLACK CHERRYA77056YJ4KIACT
GLYCYRRHIZA URALENSIS ROOT42B5YD8F0KIACT
SPEARMINTJ7I2T6IV1NIACT
PEPPERMINTV95R5KMY2BIACT
MENAQUINONE 671ANL51TLAIACT
CHOLECALCIFEROL1C6V77QF41IACT
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 PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
ndc (package): 84181-358-08
ndc (product): 84181-358
ndc11 (package): 84181035808
spl id: 8aacccae-3dc5-4814-ac01-7a042b657dd5
spl set id: 8c7e6d3a-49d9-4098-9d5e-e9792b373574

Reported adverse events (FAERS/openFDA)#

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