FDA.reportPublic FDA data

Freshenup Fluoride Fresh Mint

Manufacturer
U. S. Nonwovens Corp | Dabur India Limited
Effective date
2019-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:03

Label at a glance#

ProductFreshenup Fluoride Fresh Mint
Active ingredientSodium Monofluorophosphate
Label structure9 sections

Dosage and administration

adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician children under 6 years to minimize swallowing use a pea sized amount and supervise brushing until good habits are established children under 2 years ask a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (Total Fluoride Content - 1000 ppm approx)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

regular brushing with fluoride toothpaste helps protect teeth against cavities

Warnings

WARNINGS SECTION

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician
children under 6 yearsto minimize swallowing use a pea sized amount and supervise brushing until good habits are established
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate, Tetra Potassium Pyrophosphate

SPL UNCLASSIFIED SECTION

Plaque ShieldTM​ is a trademarks of healthy + KIND Co.

freshenup​ is a licensed trademark of healthy+KIND Co. Made In India. All rights reserved

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52553-050-02

ANTICAVITY

Freshenup

FLUORIDE TOOTHPASTE

FRESH MINT

SENSITIVE + GENTLE

TARTAR + GUM HEALTH

Fight Gengivitis

Plaque ShieldTM

Aid in Breath Control

NET WT 3.5 OZ (99.2 g)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52553-050-022023-01-30C16284748780-1f386c64a-03ac-0266-e053-dadaa90a7c1aFreshenup Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52553-050-02Freshenup Fluoride Fresh Mint99.2 g in 1 TUBEPASTE, DENTIFRICE99.21
52553-050-02Freshenup Fluoride Fresh Mint1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52553-050FRESHENUP FLUORIDE FRESH MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [U. S. NONWOVENS CORP]1Legacy NDC, 2 package rows20190815_5243d8b8-fd9c-4e06-b23b-1e268c9ef1b4.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52553-05052553-050-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium MonofluorophosphateC810JCZ56QACTIM
CALCIUM CARBONATEH0G9379FGKIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM SILICATEIJF18F77L3IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
BENZYL ALCOHOLLKG8494WBHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT

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
720ecbcc-38c2-483a-88ac-54e4b347027c5243d8b8-fd9c-4e06-b23b-1e268c9ef1b42019-08-14WarningsExact identifier
spl id: 720ecbcc-38c2-483a-88ac-54e4b347027c
spl set id: 5243d8b8-fd9c-4e06-b23b-1e268c9ef1b4

Reported adverse events (FAERS/openFDA)#

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