FDA.reportPublic FDA data

Nature Mint Anticavity

Manufacturer
Daxal Cosmetics Private Limited
Effective date
2019-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:03

Label at a glance#

ProductNature Mint Anticavity
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure6 sections

Dosage and administration

Adults & Children 6 years of age & older : Brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years : Ask a dentist or physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate - 0.76% (Total Fluoride Content - 1000 ppm Approx.)

SPL UNCLASSIFIED SECTION

DRUG FACTS

PURPOSE

OTC - PURPOSE SECTION

Anticavity.

USE

INDICATIONS & USAGE SECTION

Helps protect against cavities.

WARNINGS

WARNINGS SECTION

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 Center immediately.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Purified Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Glycerin, Sodium Carboxy Methyl Cellulose, Flavor, Sodium Saccharin, Sodium Benzoate.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults & Children 6 years of age & older : Brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

Children under 2 years : Ask a dentist or physician.

PRINCIPAL DISPLAY PANEL - 43 g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

display paneldisplay 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
76001-001-012022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity
76001-001-022022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity
76001-001-032022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity
76001-001-042022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity
76001-001-052022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity
76001-001-062022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity
76001-001-072022-01-28C16284748780-1d6a99b39-9ebe-a426-e053-dadaa90af4c2Nature Mint Anticavity

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76001-001-01Nature Mint Anticavity7.94 g in 1 PACKETPASTE, DENTIFRICE7.941
76001-001-02Nature Mint Anticavity17 g in 1 TUBEPASTE, DENTIFRICE171
76001-001-03Nature Mint Anticavity24 g in 1 TUBEPASTE, DENTIFRICE241
76001-001-04Nature Mint Anticavity43 g in 1 TUBEPASTE, DENTIFRICE431
76001-001-05Nature Mint Anticavity78 g in 1 TUBEPASTE, DENTIFRICE781
76001-001-06Nature Mint Anticavity130 g in 1 TUBEPASTE, DENTIFRICE1301
76001-001-06Nature Mint Anticavity1 in 1 CARTONPASTE, DENTIFRICE11
76001-001-07Nature Mint Anticavity181 g in 1 TUBEPASTE, DENTIFRICE1811
76001-001-07Nature Mint Anticavity1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76001-001NATURE MINT ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DAXAL COSMETICS PRIVATE LIMITED]1Legacy NDC, 9 package rows20190814_90044dec-5d58-13e0-e053-2a95a90ad994.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
76001-00176001-001-01, 76001-001-02, 76001-001-03, 76001-001-04, 76001-001-05, 76001-001-07, 76001-001-06

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
GLYCERINPDC6A3C0OXIACT
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SODIUM BENZOATEOJ245FE5EUIACT

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
90044dec-5d5a-13e0-e053-2a95a90ad99490044dec-5d58-13e0-e053-2a95a90ad9942019-08-13WarningsExact identifier
spl id: 90044dec-5d5a-13e0-e053-2a95a90ad994
spl set id: 90044dec-5d58-13e0-e053-2a95a90ad994

Reported adverse events (FAERS/openFDA)#

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