Medpride

Manufacturer
Shield Line LLC
Effective date
2025-01-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:54

Label at a glance#

ProductMedpride
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Indications and uses

aids in the prevention of dental cavities

Dosage and administration

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 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 ■ children under 6 years of age: do not use unless directe...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age

WARNINGS SECTION

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 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 ■ children under 6 years of age: do not use unless directed by a doctor or dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, sodium saccharin, sodium methylparaben, sodium propylparaben

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG FACT PANELDRUG FACT PANELfront panelfront panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-9005-32024-03-20C16284748780-11030e365-427e-111a-e063-dadaa90a10e2Drug Facts
52410-9005-42024-03-20C16284748780-11030e365-427e-111a-e063-dadaa90a10e2Drug Facts
52410-9005-32024-01-30C16284748780-11030e365-427e-111a-e063-dadaa90a10e2Drug Facts
52410-9005-42024-01-30C16284748780-11030e365-427e-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-9005-3Medpride42.5 g in 1 TUBEPASTE, DENTIFRICE42.55
52410-9005-4Medpride78 g in 1 TUBEPASTE, DENTIFRICE785

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-9005MEDPRIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHIELD LINE LLC]5Current NDC, Legacy NDC, 2 package rows20250117_9c1b0420-6b57-4914-99fe-df6a494815c3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P91
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHK1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
52410-900552410-9005-3, 52410-9005-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKCAPSULE / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET / ORAL0.19 mgExact identifier — unii candidate
18 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii+route
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET, ORALLY DISINTEGRATING / ORAL0.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii+route
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKPOWDER, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
18 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSOLUTION / ORAL134 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSOLUTION / ORAL134 mgExact identifier — unii candidate
18 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSUSPENSION / ORAL80 mgExact identifier — unii candidate
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSUSPENSION / ORAL80 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKCAPSULE / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET, ORALLY DISINTEGRATING / ORAL0.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET / ORAL0.19 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSUSPENSION / ORAL80 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKPOWDER, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSOLUTION / ORAL134 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKCAPSULE / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii+route
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKPOWDER, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET / ORAL0.19 mgExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET, ORALLY DISINTEGRATING / ORAL0.3 mgExact identifier — unii candidate
18 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
MedprideSODIUM MONOFLUOROPHOSPHATEShield Line LLC9c1b0420-6b57-4914-99fe-df6a494815c32025-01-16WarningsExact identifier
ndc (package): 52410-9005-3
ndc (package): 52410-9005-4
ndc (product): 52410-9005
ndc11 (package): 52410900503
ndc11 (package): 52410900504
spl id: 2bd54896-ace8-e65b-e063-6294a90a8cd4
spl set id: 9c1b0420-6b57-4914-99fe-df6a494815c3

Reported adverse events (FAERS/openFDA)#

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