ASTONEA -SODIUM FLUORIDE

Manufacturer: ASTONEA LABS PRIVATE LIMITED
Effective date: 2024-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:14:18

Label at a glance#

ProductASTONEA -SODIUM FLUORIDE

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Dosage and administration

Do not Swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children under 6 years of age: Do not use unless directed by a ...

Storage and handling

Store at 59°-86°F (15°-30°C) Avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22% w/w

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not Swallow
Supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
Children under 6 years of age: Do not use unless directed by a dentist or physician

Other Information

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C)
Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Flavor, Glycerin, PEG-1500, Silica, Sodium Benzoate, Sodium Carboxymethyl Cellulose, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Tetra Sodium Pyrophosphate, Titanium Dioxide, Water

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	3
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	3
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77338-091-38	2024-06-25	C162847	48780-1	1030e365-315d-111a-e063-dadaa90a10e2	astonea -sodium fluoride
77338-091-38	2024-01-30	C162847	48780-1	1030e365-315d-111a-e063-dadaa90a10e2	astonea -sodium fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-091-38	ASTONEA -SODIUM FLUORIDE	43 g in 1 TUBE	PASTE, DENTIFRICE	43		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-091	ASTONEA -SODIUM FLUORIDE (SODIUM FLORIDE) PASTE, DENTIFRICE [ASTONEA LABS PRIVATE LIMITED]	3	Legacy NDC, 1 package rows	20240627_e69bc270-e909-1139-e053-2995a90a039b.zip

Products#

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

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

ASTONEA -SODIUM FLUORIDE
Sodium Floride
POLYETHYLENE GLYCOL 1500
TITANIUM DIOXIDE
WATER
SORBITOL
SILICON DIOXIDE
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM PYROPHOSPHATE
SODIUM FLUORIDE
FLUORIDE ION
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-091	77338-091-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
GLYCERIN	PDC6A3C0OX	IACT

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
1bbb2aec-aab9-7f11-e063-6294a90a795a			e69bc270-e909-1139-e053-2995a90a039b	2024-06-25	Warnings	Exact identifier spl id: 1bbb2aec-aab9-7f11-e063-6294a90a795a spl set id: e69bc270-e909-1139-e053-2995a90a039b

Reported adverse events (FAERS/openFDA)#

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