Home NDC 51326-858 Replenix Sheer
Product NDC 51326-858
11-digit product format 513260858
Labeler code 51326
Product ID 51326-858_1abf4f5e-ecc6-41c4-9bfb-617ad5a786fd
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Topiderm, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-23
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 165; 23 mg/g; 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 Replenix Sheer
Brand name suffix SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 165 mg/g TITANIUM DIOXIDE 23 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51326-858-01 Replenix SheerSPF 50 60 g in 1 BOTTLE, PLASTIC CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51326-858 REPLENIX SHEER SPF 50 (ZINC OXIDE TITANIUM DIOXIDE) CREAM [TOPIDERM, INC.] 1 Current NDC, 1 package rows 20240730_37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4.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 81 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51326-858-01 51326085801 60 g in 1 BOTTLE, PLASTIC (51326-858-01) 60 g 2021-07-23 No No Current