FDA.reportPublic FDA data

Fluoride Gel

Manufacturer
Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd | Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
Effective date
2016-07-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:46:29

Label at a glance#

ProductFluoride Gel
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

helps protect against cavities.

Dosage and administration

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician. Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years:Ask a dentist or a physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%(0.15 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.

Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN3
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD3
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51289-400-012020-01-31C16284748780-19d75b9d0-40b4-f424-e053-dadaa90a57ceCharm-Tex Fluoride Gel Toothpaste
51289-400-022020-01-31C16284748780-19d75b9d0-40b4-f424-e053-dadaa90a57ceCharm-Tex Fluoride Gel Toothpaste
51289-400-032020-01-31C16284748780-19d75b9d0-40b4-f424-e053-dadaa90a57ceCharm-Tex Fluoride Gel Toothpaste
51289-400-042020-01-31C16284748780-19d75b9d0-40b4-f424-e053-dadaa90a57ceCharm-Tex Fluoride Gel Toothpaste
51289-400-052020-01-31C16284748780-19d75b9d0-40b4-f424-e053-dadaa90a57ceCharm-Tex Fluoride Gel Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51289-400-01Fluoride Gel720 in 1 BOXPASTE7203
51289-400-01Fluoride Gel17 g in 1 TUBEPASTE173
51289-400-02Fluoride Gel720 in 1 BOXPASTE7203
51289-400-02Fluoride Gel24 g in 1 TUBEPASTE243
51289-400-03Fluoride Gel144 in 1 BOXPASTE1443
51289-400-03Fluoride Gel43 g in 1 TUBEPASTE433
51289-400-04Fluoride Gel0.22 g in 1 TUBEPASTE0.223
51289-400-04Fluoride Gel1000 in 1 BOXPASTE10003
51289-400-05Fluoride Gel7 g in 1 TUBEPASTE73
51289-400-05Fluoride Gel1000 in 1 BOXPASTE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51289-400FLUORIDE GEL (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO.,LTD]3Legacy NDC, 10 package rows20160707_33ab7045-39e6-3066-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51289-40051289-400-01, 51289-400-02, 51289-400-03, 51289-400-04, 51289-400-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOCYSTEINE LYSINE MONOHYDRATEQA5ZP9OL3EIACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYL PARAOXONUE1A2XL95HIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM SILICATEIJF18F77L3IACT
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT

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
37083c7b-abe9-5cd6-e054-00144ff8d46c33ab7045-39e6-3066-e054-00144ff88e882016-07-07WarningsExact identifier
spl id: 37083c7b-abe9-5cd6-e054-00144ff8d46c
spl set id: 33ab7045-39e6-3066-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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