FDA.reportPublic FDA data

MIPaste One Kids Blue Raspberry

Product NDC
61596-103
11-digit product format
615960103
Labeler code
61596
Product ID
61596-103_4651cb98-dcff-a45b-e063-6294a90ad8b2
Type
HUMAN OTC DRUG
Nonproprietary name
MIPaste One Kids Blue Raspberry
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
GC America Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-21
Substance
SODIUM FLUORIDE
Active strength
.24 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
MIPaste One Kids Blue Raspberry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-103-01MIPaste One Kids Blue Raspberry0.46 g in 1 TUBEPASTE, DENTIFRICE0.464
61596-103-02MIPaste One Kids Blue Raspberry1 in 1 BOTTLE, UNIT-DOSEPASTE, DENTIFRICE14
61596-103-10MIPaste One Kids Blue Raspberry10 in 1 BOXPASTE, DENTIFRICE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-103MIPASTE ONE KIDS BLUE RASPBERRY PASTE, DENTIFRICE [GC AMERICA INC.]3Current NDC, Legacy NDC, 3 package rows20240128_c07e1058-903b-fd47-e053-2995a90afdab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNc07e1058-903b-fd47-e053-2995a90afdab4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDc07e1058-903b-fd47-e053-2995a90afdab4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYc07e1058-903b-fd47-e053-2995a90afdab4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYc07e1058-903b-fd47-e053-2995a90afdab4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYc07e1058-903b-fd47-e053-2995a90afdab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61596-103-01615960103010.46 g in 1 TUBE0.46 gHistorical
61596-103-02615960103021 in 1 BOTTLE, UNIT-DOSEHistorical
61596-103-106159601031010 BOTTLE, UNIT-DOSE in 1 BOX (61596-103-10) / 1 TUBE in 1 BOTTLE, UNIT-DOSE (61596-103-02) / .46 g in 1 TUBE (61596-103-01) 2021-04-210000-00-00NoNoCurrent