botalab HERBAL COMPLETE TOOTH

Product NDC
50555-201
11-digit product format
505550201
Labeler code
50555
Product ID
50555-201_51365ef7-ed95-2650-e063-6394a90ab89e
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
KMPHARMACEUTICAL CO., LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
botalab HERBAL COMPLETE TOOTH
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50555-201-01botalab HERBAL COMPLETE TOOTH150 g in 1 TUBEPASTE, DENTIFRICE1501
50555-201-02botalab HERBAL COMPLETE TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN51365ef7-ed94-2650-e063-6394a90ab89e1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD51365ef7-ed94-2650-e063-6394a90ab89e1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY51365ef7-ed94-2650-e063-6394a90ab89e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50555-201-0150555020101150 g in 1 TUBE150 gHistorical
50555-201-02505550201021 TUBE in 1 CARTON (50555-201-02) / 150 g in 1 TUBE (50555-201-01) 1 tube2026-05-01NoNoCurrent