FDA.reportPublic FDA data

DawnMist

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
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DawnMist Fluoride Toothpaste

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

WARNINGS SECTION

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

Calcium Carbonate, Carboxymethylcellulose Sodium, Flavor, Guaraprolose, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-0

Dukal

0.6oz (17g)

RTP06RTP06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-1

Dukal

0.85oz (24g)

RTP085RTP085

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-2

Dukal

1.5oz (43g)

RTP15RTP15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-3

Dukal

2.75oz (78g)

RTP27RTP27

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-4

Dukal

4.75oz (134g)

RTP47BRTP47B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-5

Dukal

6.4oz (181g)

RTP64RTP64

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
65517-2005-0DawnMist17 g in 1 TUBEPASTE, DENTIFRICE173
65517-2005-1DawnMist24 g in 1 TUBEPASTE, DENTIFRICE243
65517-2005-2DawnMist43 g in 1 TUBEPASTE, DENTIFRICE433
65517-2005-3DawnMist78 g in 1 TUBEPASTE, DENTIFRICE783
65517-2005-4DawnMist134 g in 1 TUBEPASTE, DENTIFRICE1343
65517-2005-5DawnMist181 g in 1 TUBEPASTE, DENTIFRICE1813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2005DAWNMIST (TOOTHPASTE) PASTE, DENTIFRICE [DUKAL LLC]3Current NDC, 6 package rows20250210_147f7738-5080-9907-e063-6294a90a6170.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65517-200565517-2005-0, 65517-2005-1, 65517-2005-2, 65517-2005-3, 65517-2005-4, 65517-2005-5

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
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GUARAPROLOSE (1300 MPA.S AT 1%)1530WMS90SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
ndc (package): 65517-2005-5
ndc (package): 65517-2005-3
ndc (package): 65517-2005-2
ndc (package): 65517-2005-0
ndc (package): 65517-2005-1
ndc (package): 65517-2005-4
ndc (product): 65517-2005
ndc11 (package): 65517200504
ndc11 (package): 65517200502
ndc11 (package): 65517200501
ndc11 (package): 65517200505
ndc11 (package): 65517200500
ndc11 (package): 65517200503
spl id: 2d8d37f1-43ea-5d8b-e063-6394a90a8e1c
spl set id: 147f7738-5080-9907-e063-6294a90a6170

Reported adverse events (FAERS/openFDA)#

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