Home NDC 52257-1400 ATOMY DERMA CALMING SUN
Product NDC 52257-1400
11-digit product format 522571400
Labeler code 52257
Product ID 52257-1400_d9c210b4-3004-44e0-a417-0394f5af6302
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form STICK
Route TOPICAL
Labeler ATOMY CO., LTD.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
Substance TITANIUM DIOXIDE
Active strength 1.41 g/16g
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 DERMA CALMING SUN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 1.41 g/16g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP 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 52257-1400-1 ATOMY DERMA CALMING SUN 16 g in 1 CARTON STICK 16 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52257-1400 ATOMY DERMA CALMING SUN (TITANIUM DIOXIDE) STICK [ATOMY CO., LTD.] 2 Current NDC, Legacy NDC, 1 package rows 20240131_fd5fc3ba-6e7c-4e48-8e65-47c03141df45.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 109 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52257-1400-1 52257140001 16 g in 1 CARTON (52257-1400-1) 16 g 2021-05-01 0000-00-00 No No Current