Home NDC 50555-201 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base botalab HERBAL COMPLETE TOOTH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .22 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245598 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50555-201-01 botalab HERBAL COMPLETE TOOTH 150 g in 1 TUBE PASTE, DENTIFRICE 150 1 50555-201-02 botalab HERBAL COMPLETE TOOTH 1 in 1 CARTON PASTE, DENTIFRICE 1 1
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 43 of 49 · 974 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50555-201-01 50555020101 150 g in 1 TUBE 150 g Historical 50555-201-02 50555020102 1 TUBE in 1 CARTON (50555-201-02) / 150 g in 1 TUBE (50555-201-01) 1 tube 2026-05-01 No No Current