Home NDC 85601-050 DENTI BUONGIORNO ORIGINAL TOOTH
Product NDC 85601-050
11-digit product format 856010050
Labeler code 85601
Product ID 85601-050_4114ab1e-c4ad-5286-e063-6394a90af3cd
Type HUMAN OTC DRUG
Nonproprietary name Silica, Sodium Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler ATOSAFE CO., Ltd
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-04-01
Substance SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE
Active strength 18; .76 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings • Keep out of reach of children under 6 years of age. • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base DENTI BUONGIORNO ORIGINAL TOOTH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILICON DIOXIDE 18 g/100g SODIUM MONOFLUOROPHOSPHATE .76 g/100g
Harmonized Identifiers# Field, Values table Field Values Unii ETJ7Z6XBU4, C810JCZ56Q
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85601-050-01 DENTI BUONGIORNO ORIGINAL TOOTH 100 g in 1 TUBE PASTE, DENTIFRICE 100 1 85601-050-02 DENTI BUONGIORNO ORIGINAL TOOTH 1 in 1 CARTON PASTE, DENTIFRICE 1 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85601-050-01 85601005001 100 g in 1 TUBE 100 g Historical 85601-050-02 85601005002 1 TUBE in 1 CARTON (85601-050-02) / 100 g in 1 TUBE (85601-050-01) 1 tube 2025-04-01 No No Current