FDA.reportPublic FDA data

teeth desensitizing and remineralizing gel

Manufacturer
Fuzhou Difeng Bio-tech Co., Ltd.
Effective date
2018-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:53:58

Label at a glance#

Productteeth desensitizing and remineralizing gel
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure6 sections

Indications and uses

To relieve the discomfort from teeth sensitivity caused by thermal, chemical changes, periodontal conditions...etc. Aids in the prevention of dental cavities.

Dosage and administration

Adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on sensitive teeth, or use it in a custom mouth tray. Keep your mouth open for 10-15 mins. Then rinse your month to clean the gel. Use it 1-2 times daily or as recommended by a dentist or physician. Children under 18 years of age and pregnant, breast feeding women: consult a dentist or physician prior to use.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%
Sodium Fluoride 0.15%

Purpose

OTC - PURPOSE SECTION

.antihypersensitivity
.anticavity

Uses

INDICATIONS & USAGE SECTION


To relieve the discomfort from teeth sensitivity caused by thermal, chemical changes, periodontal
conditions...etc. Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Do not swallow. Avoid contact with eyes. Discontinue use and consultant your dentist if allegric
reaction or gum irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on
sensitive teeth, or use it in a custom mouth tray. Keep your mouth open for 10-15 mins. Then rinse
your month to clean the gel. Use it 1-2 times daily or as recommended by a dentist or physician.
Children under 18 years of age and pregnant, breast feeding women: consult a dentist or
physician prior to use.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Carbopol, Deionized Water, Glycerin, Menthol, Sodium Saccharine,SODIUM MONOFLUOROPHOSPHATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSN3
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCD3
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY3
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSY3
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY3
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49410-200-012020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-022020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-032020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-042020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-052020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-062020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-072020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200
49410-200-082020-01-31C16284748780-19d75b9d0-f43c-f424-e053-dadaa90a57ceteeth desensitizing and remineralizing gel ​49410-200

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49410-200-01teeth desensitizing and remineralizing gel200 in 1 CONTAINERPASTE2003
49410-200-01teeth desensitizing and remineralizing gel5 in 1 CARTONPASTE53
49410-200-02teeth desensitizing and remineralizing gel100 in 1 CONTAINERPASTE1003
49410-200-02teeth desensitizing and remineralizing gel5 in 1 CARTONPASTE53
49410-200-03teeth desensitizing and remineralizing gel100 in 1 CONTAINERPASTE1003
49410-200-03teeth desensitizing and remineralizing gel5 in 1 CARTONPASTE53
49410-200-04teeth desensitizing and remineralizing gel80 in 1 CONTAINERPASTE803
49410-200-04teeth desensitizing and remineralizing gel5 in 1 CARTONPASTE53
49410-200-05teeth desensitizing and remineralizing gel6 in 1 CARTONPASTE63
49410-200-05teeth desensitizing and remineralizing gel300 in 1 CONTAINERPASTE3003
49410-200-06teeth desensitizing and remineralizing gel200 in 1 CONTAINERPASTE2003
49410-200-06teeth desensitizing and remineralizing gel6 in 1 CARTONPASTE63
49410-200-07teeth desensitizing and remineralizing gel6 in 1 CARTONPASTE63
49410-200-07teeth desensitizing and remineralizing gel333 in 1 CONTAINERPASTE3333
49410-200-08teeth desensitizing and remineralizing gel300 in 1 CARTONPASTE3003
49410-200-08teeth desensitizing and remineralizing gel3.5 g in 1 VIAL, SINGLE-USEPASTE3.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49410-200TEETH DESENSITIZING AND REMINERALIZING GEL (POTASSIUM NITRATE,SODIUM FLUORIDE,SODIUM MONOFLUOROPHOSPHATE) PASTE [FUZHOU DIFENG BIO-TECH CO., LTD.]3Legacy NDC, 16 package rows20180108_2d4e6542-faa9-63f2-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49410-20049410-200-01, 49410-200-02, 49410-200-03, 49410-200-04, 49410-200-05, 49410-200-06, 49410-200-07, 49410-200-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QIACT
MENTHOLL7T10EIP3AIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOMER HOMOPOLYMER TYPE AF68VH75CJCIACT

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
62180c5e-1369-1c60-e053-2a91aa0a36682d4e6542-faa9-63f2-e054-00144ff8d46c2018-01-06WarningsExact identifier
spl id: 62180c5e-1369-1c60-e053-2a91aa0a3668
spl set id: 2d4e6542-faa9-63f2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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