Home NDC 76348-580 Pediadermics eczema 3
Product NDC 76348-580
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76348-580-06 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76348-580-06 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76348-580-06 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76348-580-06 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-580-06 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-580-06 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-580-06 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 7 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sosnowskis Magic Healing Multi action CAMPHOR AND COLLOIDAL OATMEAL Herstat (USA) Inc. 38cd8f11-7264-a004-e063-6294a90a3a1b 2026-07-03 Warnings Exact identifier application number: M016 Petroleum Skin Protectant WHITE PETROLATUM Publix Super Markets, Inc. c94b5574-3fd7-48a8-94ef-db5d7184fa10 2026-07-02 Warnings, Adverse reactions Exact identifier application number: M016 Drs. Pharmacy Baby Healing ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 55a6981c-1b32-f448-e063-6294a90ac6d8 2026-07-02 Warnings Exact identifier application number: M016 AVANCE ALOE INCONTINENCE CARE DIMETICONE SMART CHOICE MEDICAL INC. 558d239e-b0cf-c145-e063-6294a90a8a8b 2026-07-01 Warnings Exact identifier application number: M016 DIMETHICONE SKIN PROTECTANT DIMETHICONE VIVE HEALTH LLC 5591a321-4831-1844-e063-6394a90a12d1 2026-07-01 Warnings Exact identifier application number: M016 Drs. Pharmacy healing PETROLATUM OL PHARMA TECH, LLC Drs PHARMACY 55947cd9-ca25-0844-e063-6294a90a381f 2026-07-01 Warnings Exact identifier application number: M016 AVANCE ALOE INCONTINENCE CARE DIMETICONE SMART CHOICE MEDICAL INC. 55833e0f-d184-16a2-e063-6394a90acfd3 2026-06-30 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 55664a0f-7d46-f002-e063-6394a90a2dc7 2026-06-29 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 5566bce3-fc49-5ef4-e063-6294a90abc7a 2026-06-29 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 5568ada5-3ae6-3366-e063-6294a90a7119 2026-06-29 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 55698d88-aae7-c46c-e063-6394a90ad0ac 2026-06-29 Warnings Exact identifier application number: M016 Earth Baby Diaper Rash Cream ZINC OXIDE Earth Baby, Inc 42c5cf9a-0a35-5681-e054-00144ff8d46c 2026-06-28 Warnings Exact identifier application number: M016 ORLASKIN HYDROGEL EYE MASK ALLANTOIN Guangzhou Yapheon Health Industry Co., Ltd. 552d072b-396f-c88a-e063-6294a90aabcd 2026-06-26 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM Medline Industries, LP 3c442890-733d-8175-e063-6294a90a8b1c 2026-06-24 Warnings Exact identifier application number: M016 MOROVAN ESTRIOL HONG KONG UNORDERED TRADING CO., LIMITED 54fa4308-44a4-e9dd-e063-6394a90a0cd7 2026-06-24 Warnings Exact identifier application number: M016 EELHOE Sleep Aid Patch GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 550b0494-ca6d-c897-e063-6394a90a8751 2026-06-24 Warnings Exact identifier application number: M016 Hair Regrowth Liquid GLYCERIN Shantou Woodsleep Biotechnology Co., Ltd. 54e662e7-9c63-ad6b-e063-6294a90a1b8d 2026-06-23 Warnings Exact identifier application number: M016 RoyceDerm Eczema Relief Body Wash COLLOIDAL OATMEAL 2% RoyceDerm LLC 54e74eb4-1b42-a748-e063-6394a90aeb16 2026-06-23 Warnings Exact identifier application number: M016 Comfort Shield Barrier DIMETHICONE Sage Products LLC cc08f571-84ae-4c2f-b09d-a83a8efc39f5 2026-06-23 Warnings Exact identifier application number: M016 CLEAR ANTI ITCH PRAMOXINE HCL, ZINC ACETATE LOTION H E B 54f04056-d805-8c62-e063-6394a90ab740 2026-06-23 Warnings, Adverse reactions 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