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 26 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DERMATITIS FACE BALM COLLOIDAL OATMEAL Skinfix, Inc. 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 2026-01-08 Warnings Exact identifier application number: M016 First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power COLLOIDAL OATMEAL JCS Global Distribution, Inc. 47d06283-21cd-4a69-e063-6294a90adb05 2026-01-07 Warnings Exact identifier application number: M016 DE LA CRUZ DIAPER RASH ALLANTOIN, PETROLATUM, AND ZINC OXIDE DLC Laboratories, Inc. 5949aa0f-a7cb-453c-81fd-9fa24653a452 2026-01-07 Warnings Exact identifier application number: M016 Thera Wise Natural Hemorrhoidal WITCH HAZEL Derma Wise Skin Care Ltd. a29fb680-cfc8-4a7b-9970-563fa0e2bed6 2026-01-06 Warnings Exact identifier application number: M016 Sky and Sol SPF25 Lip Balm SKY AND SOL SPF25 LIP BALM Guangzhou Fantesy Biotechnology Co.,Ltd 1f37c0c3-6443-60a3-e063-6394a90a596f 2026-01-05 Warnings Exact identifier application number: M016 Remedy Essentials WHITE PETROLATUM,ZINC OXIDE Medline Industries, LP 42a033d6-782b-2d7f-e054-00144ff8d46c 2026-01-05 Warnings Exact identifier application number: M016 BUNUSS Estriol Face ESTRIOL Jiashen International Trade Limited 478b5690-038a-ba1c-e063-6394a90a3ad6 2026-01-04 Warnings Exact identifier application number: M016 Skin Protectant for Babies and kids SKIN PROTECTANT OINTMENT Neilmed Pharmaceuticals Inc. 448b70db-ca81-db7b-e063-6294a90a5f0d 2026-01-02 Warnings Exact identifier application number: M016 Puriya Eczema Cream COLLOIDAL OATMEAL IPC Republic, Inc. 24ac044e-13fa-5ff6-e063-6294a90a9985 2026-01-01 Warnings Exact identifier application number: M016 Scarzen DIMETHICONE Village Pharma LLC 1550f4e5-22e2-491f-8184-de65da7234e6 2026-01-01 Warnings Exact identifier application number: M016 NUVALU 100 PURE PETROLEUM WHITE PETROLATUM JC SALES 48f74b99-7ead-b0d0-e063-6394a90a4929 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM JC SALES 48f79c2a-b314-169f-e063-6294a90a576e 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM JC SALES 490ac0a6-eac0-a74f-e063-6394a90a84ed 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM COCOA BUTTER WHITE PETROLATUM JC SALES 490af001-c78c-e2d2-e063-6394a90abdb0 2026-01-01 Warnings Exact identifier application number: M016 NUVALU 100 PURE PETROLEUM WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 4946ac1a-f475-fbb1-e063-6394a90a30bc 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 4946d1b7-ae1b-1e73-e063-6394a90a1ed2 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 49471d77-303a-8536-e063-6394a90aea51 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM COCOA BUTTER WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 49472319-09d1-7c4f-e063-6294a90a26a7 2026-01-01 Warnings Exact identifier application number: M016 Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 1fa6282a-172e-f5c8-e063-6294a90a4fb1 2025-12-31 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 27713ae6-b428-e0d7-e063-6394a90a7a89 2025-12-31 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