Home NDC 82897-379 GL HEALTH Barrier Skin Protectant
Product NDC 82897-379
11-digit product format 828970379
Labeler code 82897
Product ID 82897-379_0976dfc5-c368-11fe-e063-6294a90aa2bb
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 2022-12-16
Substance ZINC OXIDE
Active strength 205 mg/g
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 GL HEALTH Barrier Skin Protectant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 205 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2623963 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 82897-379-00 GL HEALTH Barrier Skin Protectant 113.4 g in 1 TUBE CREAM 113.4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82897-379 GL HEALTH BARRIER SKIN PROTECTANT (ZINC OXIDE) CREAM [GL HEALTH, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231106_76cfa330-fea9-48d4-b187-469154765d39.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 30 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 Marketing end Sample Exclude flag Status 82897-379-00 82897037900 113.4 g in 1 TUBE (82897-379-00) 113.4 g 2022-12-16 0000-00-00 No No Current