FDA.reportPublic FDA data

DawnMist

Product NDC
65517-2005
11-digit product format
655172005
Labeler code
65517
Product ID
65517-2005_2d8d37f1-43ea-5d8b-e063-6394a90a8e1c
Type
HUMAN OTC DRUG
Nonproprietary name
Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Dukal LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-25
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DawnMist
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.22 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN147f7738-5080-9907-e063-6294a90a61703
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD147f7738-5080-9907-e063-6294a90a61703
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY147f7738-5080-9907-e063-6294a90a61703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65517-2005-06551720050017 g in 1 TUBE (65517-2005-0) 17 g2024-03-25NoNoCurrent
65517-2005-16551720050124 g in 1 TUBE (65517-2005-1) 24 g2024-03-25NoNoCurrent
65517-2005-26551720050243 g in 1 TUBE (65517-2005-2) 43 g2024-03-25NoNoCurrent
65517-2005-36551720050378 g in 1 TUBE (65517-2005-3) 78 g2024-03-25NoNoCurrent
65517-2005-465517200504134 g in 1 TUBE (65517-2005-4) 134 g2024-03-25NoNoCurrent
65517-2005-565517200505181 g in 1 TUBE (65517-2005-5) 181 g2024-03-25NoNoCurrent