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 29 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TrueLipids Relieve and Protect CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27c0af9b-f397-dec3-e063-6394a90aed8b 2025-12-15 Warnings Exact identifier application number: M016 Truelipids TrueLips Lip Balm CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27c155dc-f194-6750-e063-6394a90a20b1 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing PETROLATUM Beiersdorf Inc 0a17bf6f-6114-4647-a509-65999255c37b 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Original PETROLATUM Beiersdorf Inc d38ec874-7b8c-4b9b-92b6-286278bb67f3 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing Diaper Rash ZINC OXIDE Beiersdorf Inc dec07dfc-67a2-46ad-8fab-828488bdba15 2025-12-15 Warnings Exact identifier application number: M016 HealthWise Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 7ba0ac53-c78c-4a70-a977-a082f731919e 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Lip Protectant and Sunscreen PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Beiersdorf Inc a43c2802-9cf1-477e-9f93-e11cf40b480d 2025-12-15 Warnings Exact identifier application number: M016 Prequel Barrier Therapy Rich Skin Protectant Cream SKIN PROTECTANT CREAM The Center Brands, LLC 39945806-8f29-020b-e063-6294a90a9fc6 2025-12-13 Warnings Exact identifier application number: M016 ECZEMA COLLOIDAL OATMEAL Smith Amish, LLC 20c4bc16-ba20-47ec-e063-6394a90a8b4e 2025-12-12 Warnings Exact identifier application number: M016 Humco Calagesic CALAMINE AND PRAMOXINE HYDROCHLORIDE Humco Holding Group, Inc. 8c43590d-56ec-4588-8076-99ba94a16685 2025-12-11 Warnings Exact identifier application number: M016 Soteri Skin Baby Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d88ff2-22aa-8447-e063-6294a90aea0e 2025-12-10 Warnings Exact identifier application number: M016 Soteri Skin Active Flare-Up Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc. 41b558d9-55ba-97ff-e063-6394a90a963b 2025-12-10 Warnings Exact identifier application number: M016 CeraVe Developed With Dermatologist Baby Eczema Relief Cream OATMEAL L'Oreal USA Products Inc 5d392529-9f0c-40bc-92ca-7003f8e64b1c 2025-12-09 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Eczema Relief Moisturizing COLLOIDAL OATMEAL L'Oreal USA Products Inc c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed 2025-12-09 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 446ddb19-4bdb-6827-e063-6394a90a6af8 2025-12-09 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 45864832-51bb-4e24-e063-6294a90ab554 2025-12-09 Warnings Exact identifier application number: M016 AquaSoothe AQUASOOTHE Dynarex Corporation 45878c3c-d05d-984c-e063-6294a90a4661 2025-12-09 Warnings Exact identifier application number: M016 Soteri Skin Long-Term Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d752cb-3866-e840-e063-6394a90acc37 2025-12-09 Warnings Exact identifier application number: M016 Earths Care Eczema OATMEAL DLC Laboratories, Inc. f72e2adf-8930-458f-a6cc-9b240b2f5eba 2025-12-08 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 4575ba40-009c-26e0-e063-6394a90adee6 2025-12-08 Warnings Exact identifier application number: M016
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