dawnmist - Donavan

Manufacturer: Donavan
Effective date: 2012-01-23
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:30:42

Label at a glance#

Productdawnmist

Active ingredientsodium fluoride

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium fluroide 0.22 % anticavity

INACTIVE INGREDIENT SECTION

calcium carbonate, water, sorbitol, silica, sodium lauryl sulphate, flavor, carboxyl methyl cellulose, sodium benzoate, sodium saccharin, potassium nitrate, menthol

DOSAGE & ADMINISTRATION SECTION

adults and children 2 yrs. 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 yrs.: 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.

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities.

OTC - PURPOSE SECTION

aids in the prevention of dental cavities.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing seek professional assistance or contact a poison control center immediately.

WARNINGS SECTION

keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing seek professional assistance or contact a poison control center immediately.

USER SAFETY WARNINGS SECTION

expiration date: expiration date and batch no. on crimp of tube.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dawnmist anticavity fluoride toothpaste.carton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	4
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	4
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55504-4341-8	2019-11-13	C162847	48780-1	97449f38-d2a1-f6ea-e053-dbdaa90aa703	Dawnmist toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55504-4341-8	dawnmist	181.4 g in 1 TUBE	PASTE	181.4		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55504-4341	DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]	4	Legacy NDC, 1 package rows	20120124_638050f5-3f08-4352-85d8-d4291d0d6237.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	4
fluoride ion	ACTIVE MOIETY	Q80VPU408O	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	4
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	4
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	4
POTASSIUM NITRATE	INACTIVE INGREDIENT	RU45X2JN0Z	4
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	4
SODIUM FLUORIDE	INACTIVE INGREDIENT	8ZYQ1474W7	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

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

dawnmist
sodium fluoride
fluoride ion
CALCIUM CARBONATE
WATER
SORBITOL
SODIUM LAURYL SULFATE
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE
PEPPERMINT
POTASSIUM NITRATE
SODIUM BENZOATE
SACCHARIN SODIUM DIHYDRATE
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55504-4341	55504-4341-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
sodium fluoride	8ZYQ1474W7	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
PEPPERMINT	V95R5KMY2B	IACT
POTASSIUM NITRATE	RU45X2JN0Z	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM DIHYDRATE	SB8ZUX40TY	IACT
SODIUM FLUORIDE	8ZYQ1474W7	IACT
MENTHOL	L7T10EIP3A	IACT

Source Document#

Source XML

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	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / AURICULAR (OTIC)	0.38 %w/w		Exact identifier — unii candidate 15 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 DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 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
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 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	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 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
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	JELLY / VAGINAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 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	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	OINTMENT / TOPICAL		14 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
87b9b288-0dd8-4b02-90b2-bb09ab8838c6			638050f5-3f08-4352-85d8-d4291d0d6237	2012-01-23	Warnings	Exact identifier spl id: 87b9b288-0dd8-4b02-90b2-bb09ab8838c6 spl set id: 638050f5-3f08-4352-85d8-d4291d0d6237

Reported adverse events (FAERS/openFDA)#

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