FDA.reportPublic FDA data

Made By Dentisits Whitening

Manufacturer
Oral Spotlight Care Inc
Effective date
2022-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:19

Label at a glance#

ProductMade By Dentists Whitening
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Sodium Fluoride 0.24%

OTC - PURPOSE SECTION

Purpose:  Anticavity

INDICATIONS & USAGE SECTION

Use: Aids in the prevention of 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 thoroughly, 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 swall-
  owing), and only use a pea size amount.
• 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:

OTC - QUESTIONS SECTION

Questions or comments?

+1 (646) 980-6461

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made By Dentists​™

Whitening

Toothpaste

Fresh Mint Flavor

Fluoride Anticavity Toothpaste

NET WT 4.2 Oz / 120 g

MADE IN THE USA

90 South Dale, Suite 8, Saint Paul,

Minnesota, USA 55102

Carton

Whitng 015 CrtnWhitng 015 Crtn

Tube

Whitng 015 TubeWhitng 015 Tube

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

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
75065-015-062024-01-30C16284748780-11030e365-2a10-111a-e063-dadaa90a10e2Made By Dentists ​™ Whitening Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75065-015-06Made By Dentists Whitening120 g in 1 TUBEPASTE1202
75065-015-06Made By Dentists Whitening1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75065-015MADE BY DENTISTS WHITENING (SODIUM FLUORIDE) PASTE [ORAL SPOTLIGHT CARE INC]2Legacy NDC, 2 package rows20220804_a4f68d70-4a4f-4414-bf27-6a2a3da6bd21.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-01575065-015-06

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 FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
b1a56a39-231e-4fe5-890a-b99950550f10a4f68d70-4a4f-4414-bf27-6a2a3da6bd212022-07-22WarningsExact identifier
spl id: b1a56a39-231e-4fe5-890a-b99950550f10
spl set id: a4f68d70-4a4f-4414-bf27-6a2a3da6bd21

Reported adverse events (FAERS/openFDA)#

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