FDA.reportPublic FDA data

Made By Dentisits Total Care

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 Total Care
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:
Cellulose Gum, Cocamidopropyl Betaine, Flavor,
Hydrated Silica, Sodium Bicarbonate, Sodium
Tripolyphosphate, Sorbitol, Titanium Dioxide,
Sodium Saccharin, Water

OTC - QUESTIONS SECTION

Questions or comments?

+1 (646) 980-6461

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made By Dentists​™

Total Care

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

TC 4.2 Mint CrtnTC 4.2 Mint Crtn

Tube

TC 4.2 Mint TubeTC 4.2 Mint 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
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
75065-016-062024-01-30C16284748780-11030e365-5018-111a-e063-dadaa90a10e2Made By Dentists ​™ Total Care Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75065-016-06Made By Dentists Total Care120 g in 1 TUBEPASTE1202
75065-016-06Made By Dentists Total Care1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75065-016MADE BY DENTISTS TOTAL CARE (SODIUM FLUORIDE) PASTE [ORAL SPOTLIGHT CARE INC]2Legacy NDC, 2 package rows20220804_460f73df-142b-40fe-bf3f-3a77b4becf54.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-01675065-016-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT

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
fd31ff12-59fb-4ff8-9ee3-c9a02a0a725f460f73df-142b-40fe-bf3f-3a77b4becf542022-07-22WarningsExact identifier
spl id: fd31ff12-59fb-4ff8-9ee3-c9a02a0a725f
spl set id: 460f73df-142b-40fe-bf3f-3a77b4becf54

Reported adverse events (FAERS/openFDA)#

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