Home NDC 51326-245 Mineral Repair SPF 45
Product NDC 51326-245
11-digit product format 513260245
Labeler code 51326
Product ID 51326-245_9069ee6d-cf2d-4462-a049-eb79d381d858
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide
Dosage form LOTION
Route TOPICAL
Labeler Topiderm, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-07
Substance ZINC OXIDE
Active strength 150 mg/g
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 Mineral Repair SPF 45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 150 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z 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 51326-245-01 Mineral Repair SPF 45 30 g in 1 BOTTLE, PUMP LOTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51326-245 MINERAL REPAIR SPF 45 (ZINC OXIDE) LOTION [TOPIDERM, INC.] 3 Current NDC, 1 package rows 20231031_84580f10-3119-4253-87a6-53d24a1f2227.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 26 of 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51326-245-01 51326024501 30 g in 1 BOTTLE, PUMP (51326-245-01) 30 g 2022-05-07 No No Current