Home NDC 64760-778 Avene Multi-Defense Fluid
Product NDC 64760-778
11-digit product format 647600778
Labeler code 64760
Product ID 64760-778_1329e56d-1e75-4bcc-e063-6394a90ae0c3
Type HUMAN OTC DRUG
Nonproprietary name Zinc oxide
Dosage form LOTION
Route TOPICAL
Labeler Pierre Fabre USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance ZINC OXIDE
Active strength 120 mg/mL
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 Avene Multi-Defense Fluid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 120 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 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 64760-778-01 Avene Multi-Defense Fluid 40 mL in 1 TUBE LOTION 40 1 64760-778-01 Avene Multi-Defense Fluid 1 in 1 CARTON LOTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64760-778 AVENE MULTI-DEFENSE FLUID (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.] 1 Current NDC, 2 package rows 20240501_1329e56d-1e74-4bcc-e063-6394a90ae0c3.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 64760-778-01 64760077801 1 TUBE in 1 CARTON (64760-778-01) / 40 mL in 1 TUBE 1 tube 2024-05-01 No No Current