Home NDC 84589-002 SUDOCREM SKIN PROTECTANT
Product NDC 84589-002
11-digit product format 845890002
Labeler code 84589
Product ID 84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler LEDA INNOVATIONS USA, INC.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-06
Substance ZINC OXIDE
Active strength 152.9 mg/g
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 SUDOCREM SKIN PROTECTANT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 152.9 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 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 84589-002-10 SUDOCREM SKIN PROTECTANT 1 in 1 BLISTER PACK CREAM 1 1 84589-002-10 SUDOCREM SKIN PROTECTANT 10 g in 1 JAR CREAM 10 1 84589-002-12 SUDOCREM SKIN PROTECTANT 125 g in 1 JAR CREAM 125 1 84589-002-25 SUDOCREM SKIN PROTECTANT 250 g in 1 JAR CREAM 250 1 84589-002-40 SUDOCREM SKIN PROTECTANT 400 g in 1 JAR CREAM 400 1 84589-002-60 SUDOCREM SKIN PROTECTANT 60 g in 1 JAR CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84589-002 SUDOCREM SKIN PROTECTANT (ZINC OXIDE) CREAM [LEDA INNOVATIONS USA, INC.] 1 Current NDC, 6 package rows 20240830_20d2cf0b-d237-fd78-e063-6394a90a8d03.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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84589-002-10 84589000210 1 JAR in 1 BLISTER PACK (84589-002-10) / 10 g in 1 JAR 1 jar 2024-08-06 No No Current 84589-002-12 84589000212 125 g in 1 JAR (84589-002-12) 125 g 2024-08-06 No No Current 84589-002-25 84589000225 250 g in 1 JAR (84589-002-25) 250 g 2024-08-06 No No Current 84589-002-40 84589000240 400 g in 1 JAR (84589-002-40) 400 g 2024-08-06 No No Current 84589-002-60 84589000260 60 g in 1 JAR (84589-002-60) 60 g 2024-08-06 No No Current