MegaFresh Fluoride Tooth

Manufacturer
American Amenities, Inc.
Effective date
2015-01-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:41:24

Label at a glance#

ProductMegaFresh Fluoride Tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 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

For external use only. Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under six years of age

OTC - ASK DOCTOR SECTION

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

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, Carboxymethylcellulose Sodium, Flavour, Glycerin, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Hydrated Silica, Saccharin Sodium, Sorbitol, Sodium Pyrophosphate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54157-103-012020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-022020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-032020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-042020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-052020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-062020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-072020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-082020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-092020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-102020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-112020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-122020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-132020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-142020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-152020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-162020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-172020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-182020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-192020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012
54157-103-202020-01-31C16284748780-19d75b9d0-2cb9-f424-e053-dadaa90a57cec40be43e-3da9-441b-8cde-82a471b94012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54157-103-01MegaFresh Fluoride Tooth17 g in 1 TUBEPASTE, DENTIFRICE174
54157-103-02MegaFresh Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE244
54157-103-03MegaFresh Fluoride Tooth35 g in 1 TUBEPASTE, DENTIFRICE354
54157-103-04MegaFresh Fluoride Tooth43 g in 1 TUBEPASTE, DENTIFRICE434
54157-103-05MegaFresh Fluoride Tooth50 g in 1 TUBEPASTE, DENTIFRICE504
54157-103-06MegaFresh Fluoride Tooth70 g in 1 TUBEPASTE, DENTIFRICE704
54157-103-07MegaFresh Fluoride Tooth78 g in 1 TUBEPASTE, DENTIFRICE784
54157-103-08MegaFresh Fluoride Tooth90 g in 1 TUBEPASTE, DENTIFRICE904
54157-103-09MegaFresh Fluoride Tooth100 g in 1 TUBEPASTE, DENTIFRICE1004
54157-103-10MegaFresh Fluoride Tooth120 g in 1 TUBEPASTE, DENTIFRICE1204
54157-103-11MegaFresh Fluoride Tooth130 g in 1 TUBEPASTE, DENTIFRICE1304
54157-103-12MegaFresh Fluoride Tooth150 g in 1 TUBEPASTE, DENTIFRICE1504
54157-103-13MegaFresh Fluoride Tooth181 g in 1 TUBEPASTE, DENTIFRICE1814
54157-103-14MegaFresh Fluoride Tooth200 g in 1 TUBEPASTE, DENTIFRICE2004
54157-103-15MegaFresh Fluoride Tooth3 g in 1 POUCHPASTE, DENTIFRICE34
54157-103-16MegaFresh Fluoride Tooth5 g in 1 POUCHPASTE, DENTIFRICE54
54157-103-17MegaFresh Fluoride Tooth10 g in 1 POUCHPASTE, DENTIFRICE104
54157-103-18MegaFresh Fluoride Tooth4.25 g in 1 POUCHPASTE, DENTIFRICE4.254
54157-103-19MegaFresh Fluoride Tooth71 g in 1 TUBEPASTE, DENTIFRICE714
54157-103-20MegaFresh Fluoride Tooth85 g in 1 TUBEPASTE, DENTIFRICE854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54157-103MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]4Legacy NDC, 20 package rows20150120_c40be43e-3da9-441b-8cde-82a471b94012.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56Q4
FLUORIDE IONACTIVE MOIETYQ80VPU408O4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3114
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P94
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J4
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8Z4
SORBITOLINACTIVE INGREDIENT506T60A25R4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 292 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii candidate
42 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii candidate
42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION/ DROPS / ORAL12.85 mg/2.5mlExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER, FOR SUSPENSION / ORAL64 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM PYROPHOSPHATESODIUM PYROPHOSPHATEO352864B8ZPASTE, DENTIFRICE / DENTAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRA-ARTICULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates

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
def7e93e-088f-45ca-90bd-8146eda23abbc40be43e-3da9-441b-8cde-82a471b940122015-01-16WarningsExact identifier
spl id: def7e93e-088f-45ca-90bd-8146eda23abb
spl set id: c40be43e-3da9-441b-8cde-82a471b94012

Reported adverse events (FAERS/openFDA)#

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