Home NDC 85394-208 Replenishing Daily Protection
Product NDC 85394-208
11-digit product format 853940208
Labeler code 85394
Product ID 85394-208_45b38a0a-d4ab-d64a-e063-6294a90a5ad1
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler The Maui Medical Group, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-20
Substance ZINC OXIDE
Active strength 160 mg/g
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 Replenishing Daily Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 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 85394-208-50 Replenishing Daily Protection 50 g in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85394-208 REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [THE MAUI MEDICAL GROUP, INC] 1 Current NDC, 1 package rows 20250511_34b96d82-7fcf-e452-e063-6394a90a781b.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 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85394-208-50 85394020850 50 g in 1 BOTTLE, PUMP (85394-208-50) 50 g 2024-06-20 No No Current