Sodium fluoride

Manufacturer: DUKAL LLC
Effective date: 2024-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:14:52

Label at a glance#

ProductSodium fluoride

Active ingredientSODIUM FLUORIDE

Label structure8 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 doctor or physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.22%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings Section

Warnings

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

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 doctor or physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

Expiration date

SPL UNCLASSIFIED SECTION

Expiration date & batch No. on crimp of tube

Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist^®

NDC: 65517-2000-0

ORAL CARE

Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

0.6 OZ. (17 g)

Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	6
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	6
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65517-2000-0	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-1	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-2	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-3	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-4	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-5	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-6	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE
65517-2000-7	2024-01-30	C162847	48780-1	1030e365-6831-111a-e063-dadaa90a10e2	DAWNMIST TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65517-2000-0	Sodium fluoride	17 g in 1 TUBE	CREAM	17	6
65517-2000-1	Sodium fluoride	24 g in 1 TUBE	CREAM	24	6
65517-2000-2	Sodium fluoride	42 g in 1 TUBE	CREAM	42	6
65517-2000-3	Sodium fluoride	78 g in 1 TUBE	CREAM	78	6
65517-2000-4	Sodium fluoride	1 in 1 BOX	CREAM	1	6
65517-2000-4	Sodium fluoride	42 g in 1 TUBE	CREAM	42	6
65517-2000-5	Sodium fluoride	78 g in 1 TUBE	CREAM	78	6
65517-2000-5	Sodium fluoride	1 in 1 BOX	CREAM	1	6
65517-2000-6	Sodium fluoride	135 g in 1 TUBE	CREAM	135	6
65517-2000-6	Sodium fluoride	1 in 1 BOX	CREAM	1	6
65517-2000-7	Sodium fluoride	181 g in 1 TUBE	CREAM	181	6
65517-2000-7	Sodium fluoride	1 in 1 BOX	CREAM	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65517-2000	SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL LLC]	6	Legacy NDC, 12 package rows	20240709_460c0f54-367a-4300-b066-5071d718ea73.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
POTASSIUM NITRATE	INACTIVE INGREDIENT	RU45X2JN0Z	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Sodium fluoride
Toothpaste
CALCIUM CARBONATE
WATER
SORBITOL
SODIUM LAURYL SULFATE
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE
POTASSIUM NITRATE
SODIUM BENZOATE
SACCHARIN SODIUM
MENTHOL
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65517-2000	65517-2000-0, 65517-2000-1, 65517-2000-2, 65517-2000-3, 65517-2000-4, 65517-2000-5, 65517-2000-6, 65517-2000-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
POTASSIUM NITRATE	RU45X2JN0Z	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
MENTHOL	L7T10EIP3A	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 251 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	JELLY / NASAL	32.5 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml		Exact identifier — unii candidate 8 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, DELAYED RELEASE / ORAL	8.4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates

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
1cbd9395-3d74-b411-e063-6394a90afb29			460c0f54-367a-4300-b066-5071d718ea73	2024-07-08	Warnings	Exact identifier spl id: 1cbd9395-3d74-b411-e063-6394a90afb29 spl set id: 460c0f54-367a-4300-b066-5071d718ea73

Reported adverse events (FAERS/openFDA)#

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