Botao Kids Strawberry Flavored with Fluoride

Product NDC
69435-1405
11-digit product format
694351405
Labeler code
69435
Product ID
69435-1405_482fd59d-1ef5-49c2-e063-6394a90a7c12
Type
HUMAN OTC DRUG
Nonproprietary name
Botao Kids Strawberry Flavored Toothpaste with Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Peer Pharm Ltd.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-19
Substance
SODIUM FLUORIDE
Active strength
.122 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Botao Kids Strawberry Flavored with Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.122 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1405-1Botao Kids Strawberry Flavored with Fluoride1 in 1 CARTONPASTE13
69435-1405-1Botao Kids Strawberry Flavored with Fluoride75 mL in 1 TUBEPASTE753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1405BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE (BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE) PASTE [PEER PHARM LTD.]2Current NDC, 2 package rows20241227_48b8d884-5e15-4145-8521-ae9ee482e392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN48b8d884-5e15-4145-8521-ae9ee482e3923
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD48b8d884-5e15-4145-8521-ae9ee482e3923
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY48b8d884-5e15-4145-8521-ae9ee482e3923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69435-1405-1694351405011 TUBE in 1 CARTON (69435-1405-1) / 75 mL in 1 TUBE1 tube2022-12-19NoNoCurrent