Home NDC 52257-1380 ATOMY PROPOLIS TOOTHPAS TE 50G
Product NDC 52257-1380
11-digit product format 522571380
Labeler code 52257
Product ID 52257-1380_bf9632ba-2fdb-4d32-b069-b2533e94f974
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate, Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler ATOMY CO., LTD.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-01
Substance SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE
Active strength .08; .05 g/50g; g/50g
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 ATOMY PROPOLIS TOOTHPAS TE 50G
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .08 g/50g SODIUM FLUORIDE .05 g/50g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup 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 1046867 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 52257-1380-1 ATOMY PROPOLIS TOOTHPAS TE 50G 50 g in 1 TUBE PASTE, DENTIFRICE 50 5 52257-1380-2 ATOMY PROPOLIS TOOTHPAS TE 50G 4 in 1 CARTON PASTE, DENTIFRICE 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52257-1380 ATOMY PROPOLIS TOOTHPAS TE 50G (SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [ATOMY CO., LTD.] 5 Current NDC, Legacy NDC, 2 package rows 20240130_98d839e3-a1aa-c83d-e053-2995a90a7e79.zip
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 35 of 51 · 1,013 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52257-1380-1 52257138001 50 g in 1 TUBE 50 g Historical 52257-1380-2 52257138002 4 TUBE in 1 CARTON (52257-1380-2) / 50 g in 1 TUBE (52257-1380-1) 4 tube 2019-12-01 0000-00-00 No No Current