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

PRINCIPALDISPLAY PANELDrug fact panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72423-0010-1	2020-01-31	C162847	48780-1	9d75b9d0-e650-f424-e053-dadaa90a57ce	Quip Anticavity Toothpaste
72423-0010-2	2020-01-31	C162847	48780-1	9d75b9d0-e650-f424-e053-dadaa90a57ce	Quip Anticavity Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72423-0010-1	NEWWORLD	133 g in 1 TUBE	PASTE, DENTIFRICE	133		1
72423-0010-2	NEWWORLD	24 g in 1 TUBE	PASTE, DENTIFRICE	24		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72423-0010	NEWWORLD (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NEW WORLD HEALTHCARE PRIVATE LIMITED]	1	Legacy NDC, 2 package rows	20180713_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.

NEWWORLD
SODIUM MONOFLUOROPHOSPHATE
CALCIUM CARBONATE
SORBITOL
WATER
SODIUM LAURYL SULFATE
HYDRATED SILICA
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM SILICATE
SODIUM BENZOATE
SACCHARIN SODIUM
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72423-0010	72423-0010-1, 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
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM SILICATE	IJF18F77L3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
707248f1-1410-7276-e053-2991aa0ac86a			707248f1-1412-7276-e053-2991aa0ac86a	2018-07-08	Warnings	Exact 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.