Home NDC 83612-0282 Organys Derma Made
Product NDC 83612-0282
11-digit product format 836120282
Labeler code 83612
Product ID 83612-0282_40c0942a-1318-6a67-e063-6294a90af373
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 2023-07-24
Substance ZINC OXIDE
Active strength 132 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 83612-0282-1 Organys Derma Made 45 mL in 1 BOTTLE, PUMP LOTION 45 5 83612-0282-2 Organys Derma Made 5 mL in 1 BOTTLE LOTION 5 5 83612-0282-3 Organys Derma Made 45 mL in 1 TUBE LOTION 45 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83612-0282 ORGANYS DERMA MADE (ZINC OXIDE) LOTION [ORGANYS BEAUTY] 3 Current NDC, 3 package rows 20241004_09b8b8c0-4066-9cbe-e063-6394a90aca24.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 83612-0282-1 83612028201 45 mL in 1 BOTTLE, PUMP 45 ml Historical 83612-0282-2 83612028202 5 mL in 1 BOTTLE (83612-0282-2) 5 ml 2023-08-21 Yes No Current 83612-0282-3 83612028203 45 mL in 1 TUBE (83612-0282-3) 45 ml 2023-07-24 No No Current