FDA.reportPublic FDA data

Auraglow Whitening

Manufacturer
Auraglow LLC
Effective date
2022-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:24

Label at a glance#

ProductAuraglow Whitening
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose  Anticavity

INDICATIONS & USAGE SECTION

Use  Aids in prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. 

​If more than used for brushing is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions 

• Adults and children 2 years of age and
older: Brush teeth thouroughly, preferably after each meal or
at least twice a day, or as directed by a dentist or doctor.
• Instruct children under 6 years of age in good brushing
​and rinsing habits (to minimize swallowing). • Supervise
children as necessary until capable of using without supervision.

• Children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Sorbitol, hydrated silica, deionized water,

glycerin, hydrogen peroxide, polyethylene

glycol, sodium tripolyphosphate, cellulose

gum, sodium methyl cocoyl tautate,

flavor, stevia, sodium bicarbonate

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Auraglow

Whitening Toothpaste

Wintergreen

C​ONTAINS FLUORIDE &

3% HYDROGEN PEROXIDE

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

001 Crtn001 Crtn

001 Tube001 Tube

res

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
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
81740-001-012024-01-30C16284748780-11030e365-34d2-111a-e063-dadaa90a10e2Auraglow Whitening Toothpaste

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81740-001AURAGLOW WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [AURAGLOW LLC]2Legacy NDC20221108_6b697a7e-bd57-4b02-8897-326c085b2bd8.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
81740-00181740-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SODIUM BICARBONATE8MDF5V39QOIACT

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
9a14e610-bf97-4797-9125-4cedeca518a86b697a7e-bd57-4b02-8897-326c085b2bd82022-12-08WarningsExact identifier
spl set id: 6b697a7e-bd57-4b02-8897-326c085b2bd8

Reported adverse events (FAERS/openFDA)#

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