FDA.reportPublic FDA data

UPC 801803 00203 MegaFresh Fluoride Tooth

Manufacturer
American Amenities, Inc.
Effective date
2017-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:46

Label at a glance#

ProductUPC 801803 00203 MegaFresh Fluoride Tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Monofluorophosphate (0.76%)

OTC - PURPOSE SECTION

Purpose: Anticavity

INDICATIONS & USAGE SECTION

Uses: Aids in the prevention of dental cavities

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under six years of age

DOSAGE & ADMINISTRATION SECTION

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Purified Water, Sorbitol, Polyethylene Glycol, Sodium Lauryl Sulfate, Hydrated Silica, Carboxymethylcellulose Sodium, Flavor, Guar Gum, Saccharin Sodium, Methylisothiazolinone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091932sodium monofluorophosphate 0.1 % ToothpastePSN1
1091932sodium monofluorophosphate 0.001 MG/MG ToothpasteSCD1
1091932sodium monofluorophosphate 0.1 % ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54157-108-012020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-022020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-032020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-042020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-052020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-062020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-072020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-082020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-092020-01-31C16284748780-19d75b9d1-0f63-f424-e053-dadaa90a57ce6d23604c-0749-4bb3-a405-c2bd06d9318c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54157-108-01UPC 801803 00203 MegaFresh Fluoride Tooth17 g in 1 TUBEPASTE, DENTIFRICE171
54157-108-02UPC 801803 00203 MegaFresh Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE241
54157-108-03UPC 801803 00203 MegaFresh Fluoride Tooth43 g in 1 TUBEPASTE, DENTIFRICE431
54157-108-04UPC 801803 00203 MegaFresh Fluoride Tooth78 g in 1 TUBEPASTE, DENTIFRICE781
54157-108-05UPC 801803 00203 MegaFresh Fluoride Tooth85 g in 1 TUBEPASTE, DENTIFRICE851
54157-108-06UPC 801803 00203 MegaFresh Fluoride Tooth130 g in 1 TUBEPASTE, DENTIFRICE1301
54157-108-07UPC 801803 00203 MegaFresh Fluoride Tooth181 g in 1 TUBEPASTE, DENTIFRICE1811
54157-108-08UPC 801803 00203 MegaFresh Fluoride Tooth200 g in 1 TUBEPASTE, DENTIFRICE2001
54157-108-09UPC 801803 00203 MegaFresh Fluoride Tooth4.25 g in 1 POUCHPASTE, DENTIFRICE4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54157-108UPC 801803 00203 MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]1Legacy NDC, 9 package rows20170629_6d23604c-0749-4bb3-a405-c2bd06d9318c.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
54157-10854157-108-01, 54157-108-02, 54157-108-03, 54157-108-04, 54157-108-05, 54157-108-06, 54157-108-07, 54157-108-08, 54157-108-09

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 MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
HYDRATED SILICAY6O7T4G8P9IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
GUAR GUME89I1637KEIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
e2a1fbd5-d2e1-4ae0-b24f-47e8e0da63966d23604c-0749-4bb3-a405-c2bd06d9318c2017-06-03WarningsExact identifier
spl id: e2a1fbd5-d2e1-4ae0-b24f-47e8e0da6396
spl set id: 6d23604c-0749-4bb3-a405-c2bd06d9318c

Reported adverse events (FAERS/openFDA)#

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