Home NDC 82897-468 MAX BARRIER Skin Protectant
Product NDC 82897-468
11-digit product format 828970468
Labeler code 82897
Product ID 82897-468_1247a3be-bad2-1253-e063-6294a90ad7e8
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler GL HEALTH, INC.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-08
Substance ZINC OXIDE
Active strength 400 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 MAX BARRIER Skin Protectant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 400 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1305337 Internal RxNorm 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 82897-468-00 MAX BARRIER Skin Protectant 3.3 mL in 1 PACKET CREAM 3.3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82897-468 MAX BARRIER SKIN PROTECTANT (ZINC OXIDE) CREAM [GL HEALTH, INC.] 1 Current NDC, 1 package rows 20240308_5eec834d-d8f3-49e3-b230-f8cf88b795e6.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 28 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82897-468-00 82897046800 3.3 mL in 1 PACKET (82897-468-00) 3.3 ml 2024-03-08 No No Current