Home NDC 85364-208 AM RESTORE
Product NDC 85364-208
11-digit product format 853640208
Labeler code 85364
Product ID 85364-208_4604bcf1-6b11-a71e-e063-6394a90acd8a
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Minder Day Spa, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-10
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 AM RESTORE
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 85364-208-15 AM RESTORE 1.5 g in 1 PACKET CREAM 1.5 2 85364-208-50 AM RESTORE 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 85364-208 AM RESTORE (ZINC OXIDE) CREAM [MINDER DAY SPA, INC.] 1 Current NDC, 1 package rows 20250524_35c010ad-e25d-f197-e063-6294a90a0efb.zip 85364-208 AM RESTORE (ZINC OXIDE) CREAM [MINDER DAY SPA, INC.] 1 Current NDC, 1 package rows 20250524_35c03804-04e9-3d54-e063-6294a90a3407.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 85364-208-15 85364020815 1.5 g in 1 PACKET (85364-208-15) 1.5 g 2023-07-10 Yes No Current 85364-208-50 85364020850 50 g in 1 BOTTLE, PUMP (85364-208-50) 50 g 2020-05-13 No No Current