FDA.reportPublic FDA data

ADVANCED WHITENING ANTI CAVITY FLUORIDE

Manufacturer
Universal Distribution Center LLC | Yangzhou Holyshine Industrial Co. Ltd
Effective date
2017-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:41

Label at a glance#

ProductADVANCED WHITENING ANTI CAVITY FLUORIDE
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.

WARNINGS SECTION

Warning

OTC - WHEN USING SECTION

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

OTC - STOP USE SECTION

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and Children 12 years of age and older:

  • apply at least a 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
  • make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after  brushing.

Children under 12 years of age: Consult a dentist or doctor.

SPL UNCLASSIFIED SECTION

Other information

  • store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

calcium carbonate, FD&C blue#1, flavor, methylparaben, poly ethylene glycol 400, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, precipited silica, tetra sodium pyrophosphate, titanium dioxide, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676979826431GTIN-13: 0676979826431
EAN-13: 0676979826431
GTIN-12: 676979826431
UPC-A: 676979826431
GTIN storage (14 digits): 00676979826431		advanced-whitening.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-035-462020-01-31C16284748780-19d75b9d0-e317-f424-e053-dadaa90a57ceADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-035-46ADVANCED WHITENING ANTI CAVITY FLUORIDE181 g in 1 TUBEPASTE1811
52000-035-46ADVANCED WHITENING ANTI CAVITY FLUORIDE1 in 1 BOXPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-035ADVANCED WHITENING ANTI CAVITY FLUORIDE (SODIUM FLUORIDE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]1Legacy NDC, 2 package rows20170621_591ac8f2-024a-4714-8a7b-eb8dc3bea528.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-03552000-035-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM SILICATEIJF18F77L3IACT
SORBITOL506T60A25RIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
527c64a8-4a3b-3ebd-e054-00144ff88e88591ac8f2-024a-4714-8a7b-eb8dc3bea5282017-06-21WarningsExact identifier
spl id: 527c64a8-4a3b-3ebd-e054-00144ff88e88
spl set id: 591ac8f2-024a-4714-8a7b-eb8dc3bea528

Reported adverse events (FAERS/openFDA)#

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