Home NDC 83612-0403 Organys Derma Made
Product NDC 83612-0403
11-digit product format 836120403
Labeler code 83612
Product ID 83612-0403_40c07d7f-5fa8-6d11-e063-6394a90a4d69
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Organys Beauty
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-07
Substance ZINC OXIDE
Active strength 132 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 Organys Derma Made
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 132 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 83612-0403-1 Organys Derma Made 45 mL in 1 BOTTLE, PUMP LOTION 45 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83612-0403 ORGANYS DERMA MADE (ZINC OXIDE) LOTION [ORGANYS BEAUTY] 1 Current NDC, 1 package rows 20231129_0b37a73b-73ca-501f-e063-6294a90a6291.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 83612-0403-1 83612040301 45 mL in 1 BOTTLE, PUMP (83612-0403-1) 45 ml 2022-06-07 No No Current