FDA.reportPublic FDA data

DawnMist Gel Fluoride

Manufacturer
Dukal LLC
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:41

Label at a glance#

ProductDawnMist Gel Fluoride
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

WARNINGS SECTION

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

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 accidently swallowed, get medical help or contact a Poison Control Center immediately.

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 doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Flavor, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Water, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2004-1

Dukal

0.6oz (17g)

GTP4654GTP4654

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2004-2

Dukal

0.85oz (24g)

GTP4661GTP4661

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2004-3

Dukal

1.5oz (43g)

GTP4678GTP4678

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2004-0

Dukal

2.75oz (78g)

GTP4685GTP4685

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN3
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD3
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2004-0DawnMist Gel Fluoride78 g in 1 TUBEGEL, DENTIFRICE783
65517-2004-1DawnMist Gel Fluoride17 g in 1 TUBEGEL, DENTIFRICE173
65517-2004-2DawnMist Gel Fluoride24 g in 1 TUBEGEL, DENTIFRICE243
65517-2004-3DawnMist Gel Fluoride43 g in 1 TUBEGEL, DENTIFRICE433

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2004DAWNMIST GEL FLUORIDE (GEL FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [DUKAL LLC]3Current NDC, 4 package rows20250210_14443184-1694-70b9-e063-6394a90a86fe.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65517-200465517-2004-1, 65517-2004-0, 65517-2004-2, 65517-2004-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
ndc (package): 65517-2004-0
ndc (package): 65517-2004-3
ndc (package): 65517-2004-1
ndc (package): 65517-2004-2
ndc (product): 65517-2004
ndc11 (package): 65517200402
ndc11 (package): 65517200401
ndc11 (package): 65517200400
ndc11 (package): 65517200403
spl id: 2d8d4082-db75-4bfc-e063-6294a90a540d
spl set id: 14443184-1694-70b9-e063-6394a90a86fe

Reported adverse events (FAERS/openFDA)#

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