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 36 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join JAFRA Fruteria Coco Fresco Lip Balm DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 9895a320-8a74-4b27-9bf1-4b492f89888c 2025-10-21 Warnings Exact identifier application number: M016 JAFRA Fruteria So Citrico DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. a68d6cda-2268-440a-9ca6-677c4e3ea0e7 2025-10-21 Warnings Exact identifier application number: M016 JAFRA Fruteria Very Verde Lip Balm DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 4f0de70b-7ebe-4381-9b46-d5b334f426e0 2025-10-21 Warnings Exact identifier application number: M016 Gelmicin Hydrocortisone with Aloe HYDROCORTISONE United Exchange Corp. bb64eca4-799d-4711-e053-2995a90af403 2025-10-21 Warnings Exact identifier application number: M016 Quadrydern HYDROCORTISONE Productos Zapotol Corp a087ad4d-9a65-19c3-e053-2995a90ab341 2025-10-21 Warnings Exact identifier application number: M016 VENROCK ROSEMARY OIL Guangzhou Oupeng Cosmetics Co., Ltd 4156b669-1817-6280-e063-6394a90aaf3a 2025-10-17 Warnings Exact identifier application number: M016 Gerigentle-Vitamins A and D PETROLATUM Geri-Gentle Corporation c36c74f7-975b-4e4c-99e3-e6921d782c71 2025-10-17 Warnings Exact identifier application number: M016 Seacall Dexamethasone Ointment. DEXAMETHASONE OINTMENT Guangdong Quadrant Ecological Technology Co., Ltd. 201adf67-773c-34a2-e063-6394a90ac525 2025-10-15 Warnings Exact identifier application number: M016 Medline ZINC OXIDE Medline Industries, LP dae45414-7401-9536-e053-2a95a90a0a86 2025-10-15 Warnings Exact identifier application number: M016 Curology Barrier Balm SKIN BARRIER BALM Curology 04b2ba38-0f81-be51-e063-6294a90af821 2025-10-15 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM Medline Industries, LP 34f3581f-39ba-4f28-9237-52f3820ab4c0 2025-10-09 Warnings Exact identifier application number: M016 Facial Fortress PYRITHIONE ZINC Pediatric Solutions, LLC cdd3c52e-4c32-46c1-bdb3-957b164190bb 2025-10-08 Warnings Exact identifier application number: M016 Happy Cappy PYRITHIONE ZINC Pediatric Solutions, LLC 3d3828d8-ee15-4aff-99d1-a121f0102a00 2025-10-08 Warnings Exact identifier application number: M016 Purforma Advanced Hand Sanitizer 70% Alcohol HAND SANITIZER 70% ALCOHOL Spartan Chemical Company, Inc. 06bd825d-914f-5ca7-e063-6394a90aec49 2025-10-06 Warnings Exact identifier application number: M016 Scar Reducer Intensive Herbal and Nutrient ALLANTOIN Quantum, Inc 5197f1fa-aae5-406c-97d9-635b8c1a88a8 2025-10-06 Warnings Exact identifier application number: M016 PURE SOL SPF 30 LIP BALM CACOA BUTTER ZINC OXIDE Brand 2022b LLC 40537561-d334-5859-e063-6394a90a92a7 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss original ZINC OXIDE Brand 2022b LLC 4056e49a-2976-38f9-e063-6394a90a786d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Nudie rose ZINC OXIDE Brand 2022b LLC 4057b0e2-1c31-abae-e063-6294a90a053d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Pink coral ZINC OXIDE Brand 2022b LLC 405865dd-7d0e-048d-e063-6394a90ab105 2025-10-04 Warnings Exact identifier application number: M016 HealthWise Medicated Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 164f4cd8-975a-40d5-e063-6394a90ae7d5 2025-10-02 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