FDA.reportPublic FDA data

Auraglow Daily

Manufacturer
Auraglow LLC
Effective date
2022-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:26

Label at a glance#

ProductAuraglow Daily
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

Deionized water, sorbitol, hydrated silica, xylitol,

glycerin, polyethylene glycol, sodium methyl

cocoyl taurate, flavor, cellulose gum, dimethicone,

monosodium phosphate, stevia, sodium benzoate

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Auraglow

Daily

Toothpaste

Strengthens Teeth

and prevents cavities.

_____________________

Wintergreen

C​ONTAINS FLUORIDE

_____________________

NET WT 4.0 OZ (113G)

Distr. by Auraglow LLC, Stamford, CT 06901

002 Crtn002 Crtn

002 Btl002 Btl

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81740-002-012024-01-30C16284748780-11030e365-5d2b-111a-e063-dadaa90a10e2Auraglow Daily Toothpaste

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81740-002AURAGLOW DAILY (SODIUM FLUORIDE) PASTE, DENTIFRICE [AURAGLOW LLC]2Legacy NDC20221108_f9924be1-5467-4abc-8185-47bc11aef59e.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
81740-00281740-002-01

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
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
54220235-1766-4e1c-8d9a-2b58dc35c14ef9924be1-5467-4abc-8185-47bc11aef59e2025-10-22WarningsExact identifier
spl set id: f9924be1-5467-4abc-8185-47bc11aef59e

Reported adverse events (FAERS/openFDA)#

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