Home NDC 76348-580-06 Pediadermics eczema 3
Product NDC 76348-580
Requested package NDC 76348-580-06
11-digit product format 763480580
Labeler code 76348
Product ID 76348-580_44fe1bad-8844-9960-e063-6394a90a8a7a
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal, Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Renu Laboratories, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-01
Substance DIMETHICONE; OATMEAL
Active strength 3.36; .168 g/168g; g/168g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Skin Barrier Activity [PE]
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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Pediadermics eczema 3
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 3.36 g/168g OATMEAL .168 g/168g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup 8PI54V663Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-580-06 Pediadermics eczema 3 168 g in 1 TUBE CREAM 168 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-580 PEDIADERMICS ECZEMA 3 (COLLOIDAL OATMEAL, DIMETHICONE) CREAM [RENU LABORATORIES, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250419_af861f0b-4387-6861-e053-2995a90a8bfa.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 31 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pediadermics eczema 3 COLLOIDAL OATMEAL, DIMETHICONE Renu Laboratories, LLC af861f0b-4387-6861-e053-2995a90a8bfa 2025-12-02 Warnings Exact identifier application number: M016 ndc (package): 76348-580-06 ndc (product): 76348-580 ndc11 (package): 76348058006 Flexitol Face and Eyelid Eczema OATMEAL LaCorium Health USA Inc. f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65 2025-12-02 Warnings Exact identifier application number: M016 ProCure HydroShield PETROLATUM 41% Twin Med LLC 3d36e664-ac10-72eb-e063-6294a90a49c4 2025-12-01 Warnings Exact identifier application number: M016 ProCure Vitamin A and D WHITE PETROLATUM 93.4% Twin Med LLC 3d385a07-2a12-fce7-e063-6294a90a32d6 2025-12-01 Warnings Exact identifier application number: M016 ESTRIOL ESTRIOL Shenzhen Mengyue Technology Co., Ltd. 44de9eb4-080e-bfbc-e063-6394a90ac0ea 2025-12-01 Warnings Exact identifier application number: M016 CareALL Creamy Petroleum Jelly PETROLATUM New World Imports, Inc e13fea4e-bd6d-425a-aa7e-1d41dc36bf00 2025-12-01 Warnings Exact identifier application number: M016 CareALL Creamy Cocoa Butter Petroleum Jelly PETROLATUM New World Imports, Inc 9358b8ef-df14-45fc-9bfd-9052577a1f88 2025-12-01 Warnings Exact identifier application number: M016 CAREALL Zinc Oxide ZINC OXIDE New World Imports Inc aa9ae4d1-4229-4894-9eaf-8588b2867472 2025-12-01 Warnings Exact identifier application number: M016 CAREALL Petroleum PETROLATUM New World Imports, Inc 47e999de-08bd-4121-b6d0-270cc603b56d 2025-12-01 Warnings Exact identifier application number: M016 HOEGOA Growth Hair Serum GLYCERIN Shantou Oralhoe Biotechnology Co., Ltd. 44b6609f-c58b-b6ac-e063-6394a90a749b 2025-11-29 Warnings Exact identifier application number: M016 OUHOE Micro Darts Tag gone Patch GLYCERIN Shantou Ouhoe Technology Co., Ltd. 33ce447c-facd-35fb-e063-6394a90a1ead 2025-11-27 Warnings Exact identifier application number: M016 OUHOE Herbal Hair Oil GLYCERIN Shantou Ouhoe Technology Co., Ltd. 30c3df30-e0c6-4efa-e063-6294a90ac40a 2025-11-27 Warnings Exact identifier application number: M016 OUHOE Aloe Soothing Sun Cream GLYCERIN Shantou Ouhoe Technology Co., Ltd. 326781e0-55dc-80fc-e063-6394a90a09aa 2025-11-27 Warnings Exact identifier application number: M016 OUHOE Ultra Anti-Acne Control Gel GLYCERIN Shantou Ouhoe Technology Co., Ltd. 3bd1b734-76b0-5264-e063-6294a90a32d0 2025-11-27 Warnings Exact identifier application number: M016 OUHOE Lipoma Cream GLYCERIN Shantou Ouhoe Technology Co., Ltd. 3cb4aed1-3b13-a62a-e063-6294a90a6c39 2025-11-27 Warnings Exact identifier application number: M016 OUHOE Para Crescimento GLYCERIN Shantou Ouhoe Technology Co., Ltd. 42fbfcac-29ab-51f7-e063-6394a90a626f 2025-11-27 Warnings Exact identifier application number: M016 OUHOE Biotin With Hydrolyzed Collagen GLYCERIN Shantou Ouhoe Technology Co., Ltd. 43138915-5fe1-6e32-e063-6294a90abefa 2025-11-27 Warnings Exact identifier application number: M016 EELHOE Pain Relief Patch GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3f835843-eb04-6273-e063-6294a90ab2f0 2025-11-27 Warnings Exact identifier application number: M016 EELHOE Skin Tag Remover GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 32922508-74ae-8347-e063-6294a90a6154 2025-11-27 Warnings Exact identifier application number: M016 EELHOE Bodyacne Removal Cleanser GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3bbebf1d-2e22-1427-e063-6294a90a7999 2025-11-27 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76348-580-06 76348058006 168 g in 1 TUBE (76348-580-06) 168 g 2020-10-01 0000-00-00 No No Current