FDA.reportPublic FDA data

NEWWORLD

Manufacturer
NEW WORLD HEALTHCARE PRIVATE LIMITED
Effective date
2018-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:16

Label at a glance#

ProductNEWWORLD
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

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

OTC - PURPOSE SECTION

Purpose

Anticavity toothpaste

INDICATIONS & USAGE SECTION

Use

aids in prevention of dental cavities

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Centre right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2yrs. & older brush teeth thoroughly after meals or at least twice a day or use as instructed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6 years
  • supervise children's brushing until good habits are established
  • children under 2 years: ask a dentist

INACTIVE INGREDIENT SECTION

Inactive ingredients

calcium carbonate, sorbitol, water, sodium lauryl sulfate, hydrated silica, sodium carboxymethyl cellulose, flavor, sodium silicate, sodium benzoate, sodium saycharin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPALPRINCIPALDISPLAY PANELDISPLAY PANELDrug fact panelDrug fact panel

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
72423-0010-12020-01-31C16284748780-19d75b9d0-e650-f424-e053-dadaa90a57ceQuip Anticavity Toothpaste
72423-0010-22020-01-31C16284748780-19d75b9d0-e650-f424-e053-dadaa90a57ceQuip Anticavity Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72423-0010-1NEWWORLD133 g in 1 TUBEPASTE, DENTIFRICE1331
72423-0010-2NEWWORLD24 g in 1 TUBEPASTE, DENTIFRICE241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72423-0010NEWWORLD (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NEW WORLD HEALTHCARE PRIVATE LIMITED]1Legacy NDC, 2 package rows20180713_707248f1-1412-7276-e053-2991aa0ac86a.zip

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
72423-001072423-0010-1, 72423-0010-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM SILICATEIJF18F77L3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
707248f1-1410-7276-e053-2991aa0ac86a707248f1-1412-7276-e053-2991aa0ac86a2018-07-08WarningsExact identifier
spl id: 707248f1-1410-7276-e053-2991aa0ac86a
spl set id: 707248f1-1412-7276-e053-2991aa0ac86a

Reported adverse events (FAERS/openFDA)#

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