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 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 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