Freshenup Fluoride Cool 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 Cool 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52553-052-02

ANTICAVITY

Freshenup

FLUORIDE TOOTHPASTE

COOL MINT

SENSITIVE + GENTLE

ENAMEL STRENGTH

Fresh Breath

Strengthen Against Acids

Gentle Whitening

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52553-052-022023-01-30C16284748780-1f386c64a-00eb-0266-e053-dadaa90a7c1aFreshenup Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52553-052-02Freshenup Fluoride Cool Mint99.2 g in 1 TUBEPASTE, DENTIFRICE99.21
52553-052-02Freshenup Fluoride Cool Mint1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52553-052FRESHENUP FLUORIDE COOL MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [U. S. NONWOVENS CORP]1Legacy NDC, 2 package rows20190815_10b92d93-a0ed-42c3-9b00-861784ccc79e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52553-05252553-052-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
94a2e3c3-0828-4125-8792-977f8fe6765310b92d93-a0ed-42c3-9b00-861784ccc79e2019-08-14WarningsExact identifier
spl id: 94a2e3c3-0828-4125-8792-977f8fe67653
spl set id: 10b92d93-a0ed-42c3-9b00-861784ccc79e

Reported adverse events (FAERS/openFDA)#

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