DawnMist

Manufacturer: Donovan Industries, Inc. | Fulijaya Manufacturing SDN. BHD.
Effective date: 2009-08-18
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:54:38

Label at a glance#

ProductDawnMist

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure11 sections

Contacts and useful links#

PhoneLabel contact1-800-334-4404

Websitewww.dawnmist.com

www.dawnmist.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredient: Purpose:
SMFP 0.76% ......................................................... Anticavity

OTC - PURPOSE SECTION

Use: Aids in the prevention of dental cavities

WARNINGS SECTION

Warning: 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.

INACTIVE INGREDIENT SECTION

Directions : 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.

DESCRIPTION SECTION

Sorbitol, Silica, Water, Sodium Lauryl Sulfate,

Xanthan Gum, Sodium Benzoate, Titanium Dioxide,

Peppermint Oil, Sodium Saccharin

DESCRIPTION SECTION

Expiration Date: Expiration Date and Batch No. on Primary Package

DESCRIPTION SECTION

Manufactured for:

Donovan Industries, Inc.

Tampa, FL 33626-3061

www.dawnmist.com

1-800-334-4404

MADE IN MALAYSIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Cavity Fighting

Formula

Mint Flavor

Toothbrush, Toothpaste and Floss Kit

100 Kits Each Net Wt .1 OZ 3g

CONTAINS ONE TOOTHBRUSH, ONE TUBE

OF TOOTHPASTE AND ONE FLOSS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Donovan Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fulijaya Kit Part 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fulijaya Kit Part 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55504-0540-1	2019-10-21	C162847	48780-1	956f9ecf-bd78-621f-e053-dbdaa90a74ad	DawnMist Toothbrush, Toothpaste and Floss Kit
55504-0540-2	2019-10-21	C162847	48780-1	956f9ecf-bd78-621f-e053-dbdaa90a74ad	DawnMist Toothbrush, Toothpaste and Floss Kit
55504-0540-3	2019-10-21	C162847	48780-1	956f9ecf-bd78-621f-e053-dbdaa90a74ad	DawnMist Toothbrush, Toothpaste and Floss Kit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55504-0540	DAWNMIST (TOOTHBRUSH, TOOTHPASTE AND FLOSS KIT) PASTE [DONOVAN INDUSTRIES, INC.]	3	Legacy NDC	20090901_85a0fde5-4d1c-450f-9e65-2849b43a72e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	3
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	3
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

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

DawnMist
Toothbrush, Toothpaste and Floss Kit
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION
SORBITOL
SILICON DIOXIDE
WATER
SODIUM LAURYL SULFATE
XANTHAN GUM
SODIUM BENZOATE
TITANIUM DIOXIDE
PEPPERMINT OIL
SACCHARIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55504-0540	55504-0540-1, 55504-0540-2, 55504-0540-3

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
Name	UNII	Kind
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIB
SORBITOL	506T60A25R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
WATER	059QF0KO0R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SACCHARIN	FST467XS7D	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 · 276 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 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	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	GRANULE, FOR SOLUTION / ORAL		16 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 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	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		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 BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 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
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 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
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 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	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	INSERT / VAGINAL		15 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / 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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 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

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
60f08b51-e2cd-4939-9acb-401fd3a718ac			85a0fde5-4d1c-450f-9e65-2849b43a72e2	2009-08-18	Warnings	Exact identifier spl id: 60f08b51-e2cd-4939-9acb-401fd3a718ac spl set id: 85a0fde5-4d1c-450f-9e65-2849b43a72e2

Reported adverse events (FAERS/openFDA)#

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