FDA.reportPublic FDA data

SMILEBAR Whitening

Manufacturer
Smilebar
Effective date
2020-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:46

Label at a glance#

ProductSMILEBAR Whitening
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium Fluoride 0.243%

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Uses

Helps protect against cavities

WARNINGS SECTION

Warnings: Keep out of reach of children under 6 yrs. of age.

If large amount (more than would be used for brushing) is swallowed, get medical help, or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Brush teeth thoroughly after

    meals or at least two times a day

   (or use as directed by a dentist)

  • Do not swallow
  • Not for children undre 6

INACTIVE INGREDIENT SECTION

Inactive ingredients:  Glycerin, Water,

Hydrated Silica, Sodium Lauryl Sulfate,

Sodium Bicarbonate, PEG, CMC, Sodium

Saccharin, Zinc Citrate, Flavor, Sucralose,

Titanium Dioxide, Tri-calcium Phosphate

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

      WHITENING TOOTHPASTE

WITH FLUORIDE + BAKING SODA

DESIGNED FOR CLEAR ALIGNER TREATMENT

      WHITENS                 PROTECTS GUMS

FIGHTS CAVITIES      RESTORES ENAMEL

NET WT 3.4 OZ  e96 G

      WHITENS TEETH BY REMOVING

SURFACE STAINS, TARTER, AND PLAQUE               SMILEBAR.COM

Distributed by SMILEBAR

303 Columbus Ave

Boston, MA 02116

Smilebar 0.243Smilebar 0.243

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73449-001-012022-01-28C16284748780-1d6a99b3a-0042-a426-e053-dadaa90af4c2SMILEBAR WHITENING TOOTHPASTE WITH FLUORIDE + BAKING SODA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73449-001-01SMILEBAR Whitening96 g in 1 TUBEPASTE, DENTIFRICE963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73449-001SMILEBAR WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [SMILEBAR]3Legacy NDC, 1 package rows20201209_5c475cee-6e7e-423f-8945-de99b5458681.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73449-00173449-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM BICARBONATE8MDF5V39QOIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ZINC CITRATEK72I3DEX9BIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT

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
08b95a08-5ffe-4300-8005-c66e1daaa2e45c475cee-6e7e-423f-8945-de99b54586812020-12-08WarningsExact identifier
spl id: 08b95a08-5ffe-4300-8005-c66e1daaa2e4
spl set id: 5c475cee-6e7e-423f-8945-de99b5458681

Reported adverse events (FAERS/openFDA)#

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