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 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 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 UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ETJ7Z6XBU4 Internal UNII lookup C810JCZ56Q Internal UNII 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 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
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 1 of 1 · 1 matching rows.
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