DawnMist Fluoride

Manufacturer: Dukal LLC
Effective date: 2024-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 20:59:32

Label at a glance#

ProductDawnMist Fluoride

Active ingredientSODIUM FLUORIDE

Label structure7 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 dentist or physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warning:

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally 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 dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Water, Sodium Lauryl Sulfate, Xanthan Gum, Sodium Benzoate, Titanium Dioxide, Mentha Piperita (Peppermint Oil), Sodium Saccharin

DawnMist Fluoride Toothpaste 0.6oz/17g (65517-2018-0)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist™ NDC: 65517-2018-0

ORAL CARE

Gel Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

0.6 OZ. (17g)

mm2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65517-2018-0	2024-01-30	C162847	48780-1	1030e365-6cd3-111a-e063-dadaa90a10e2	DawnMist Fluoride Toothpaste

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65517-2018	DAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL LLC]	4	Legacy NDC	20240709_3c0cbe62-3d3a-4040-ac37-7ca3a988b492.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

DawnMist Fluoride
Sodium Fluoride
PEPPERMINT OIL
PEPPERMINT
SORBITOL
SILICON DIOXIDE
WATER
SODIUM LAURYL SULFATE
POLYETHYLENE GLYCOL 1500
CARBOXYMETHYLCELLULOSE
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65517-2018	65517-2018-0

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
PEPPERMINT OIL	AV092KU4JH	IACT
SORBITOL	506T60A25R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
WATER	059QF0KO0R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 · 258 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 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	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 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	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO, SUSPENSION / TOPICAL	40 %w/v		Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, DELAYED RELEASE / ORAL		199 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	JELLY / VAGINAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 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	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 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
1cc3368a-f1f9-912a-e063-6294a90acad3			3c0cbe62-3d3a-4040-ac37-7ca3a988b492	2024-07-08	Warnings	Exact identifier spl id: 1cc3368a-f1f9-912a-e063-6294a90acad3 spl set id: 3c0cbe62-3d3a-4040-ac37-7ca3a988b492

Reported adverse events (FAERS/openFDA)#

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