FDA.reportPublic FDA data

Western Dental

Manufacturer
Yangzhou Hongshengding Chemical Co.,Ltd.
Effective date
2017-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:39

Label at a glance#

ProductWestern Dental
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure6 sections

Indications and uses

Aids in the prevention of dental 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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), supervise children as necessary until capable of useing without supervision.Children under 2 years of age:consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

SODIUM MONOFLUOROPHOSPHATE 0.76%

Purpose

OTC - PURPOSE SECTION

anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidentally swalowed, 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.

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 doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing),

supervise children as necessary until capable of useing without supervision.Children under 2 years of age:consult a dentist or doctor.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

calcium carbonate,CarboxyMethyl Cellulose ,glycerin,hydrated silica,purified water,Sodium Benzoate,Sodium Lauryl Sulfate,Sodium Saccharin,Sorbitol,Tetrasodium Diphosphate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71035-800-012020-01-31C16284748780-19d75b9d0-8ba8-f424-e053-dadaa90a57ce52506e52-5fd9-293a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-800-01Western Dental24 in 1 BOXPASTE241
71035-800-01Western Dental6 in 1 CARTONPASTE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71035-800WESTERN DENTAL (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]1Legacy NDC, 2 package rows20170619_52506e52-5fd9-293a-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71035-80071035-800-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYL SULFATE368GB5141JIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SORBITOL506T60A25RIACT
PHYTONADIOL TETRASODIUM DIPHOSPHATEX952T8E4RNIACT

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
5250b063-8d76-2a8e-e054-00144ff8d46c52506e52-5fd9-293a-e054-00144ff8d46c2017-06-19WarningsExact identifier
spl id: 5250b063-8d76-2a8e-e054-00144ff8d46c
spl set id: 52506e52-5fd9-293a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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