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.
| 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 |
|---|---|
| DIMETHICONE | 3.36 g/168g |
| OATMEAL | .168 g/168g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
| 8PI54V663Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| af861f0b-4387-6861-e053-2995a90a8bfa | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76348-580-06 | 2025-04-18 | C162847 | 48780-1 | 2cef2736-6a81-d83d-e063-dadaa90ab31f | Pediadermics eczema 3 |
| 76348-580-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6a81-d83d-e063-dadaa90ab31f | Pediadermics eczema 3 |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EELHOE Skin Advanced Mole Remove Serum | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3efd75f9-438a-f811-e063-6394a90a9450 | 2025-11-27 | Warnings | M016 |
| EELHOE Wart Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3127d616-1933-e783-e063-6294a90a52f7 | 2025-11-27 | Warnings | M016 |
| EELHOE Tanning Mist | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32670243-957d-3a95-e063-6394a90a5893 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Patches | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3ddd3fb0-b824-0cde-e063-6394a90aea6a | 2025-11-27 | Warnings | M016 |
| WART REMOVER | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3fd47677-52c9-6d43-e063-6294a90aa45b | 2025-11-27 | Warnings | M016 |
| JAYSUING Hair Treatment Green Ginger | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2e8e70de-a2e0-7a71-e063-6294a90a90b8 | 2025-11-27 | Warnings | M016 |
| JAYSUING Liquid Wart Flat | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 3b0c05d1-a00e-97df-e063-6394a90af3d0 | 2025-11-27 | Warnings | M016 |
| JAYSUING 7 Days Nail Fungus Treatment | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2ef424cc-815a-b331-e063-6394a90aae70 | 2025-11-27 | Warnings | M016 |
| JAYSUING Pain Relief Knee Patches | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 358a3e81-abb5-0a65-e063-6294a90a3d69 | 2025-11-27 | Warnings | M016 |
| Sandra Plasencia PDRN Rejuvenating Serum | RH-OLIGOPEPTIDE-1 | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 449634c8-ff99-1387-e063-6294a90aef45 | 2025-11-27 | Warnings | M016 |
| GLUTATHIONE | KOJIC ACIDSKIN LIGHTENING | HANCHOYEANBIOTEC Co.,Ltd. | 2be274be-e6d0-d961-e063-6294a90a2190 | 2025-11-27 | Warnings | M016 |
| XIMONTH Bee Venom Joint Cream | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 33d18888-8d06-da13-e063-6294a90a743c | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Wart Remover Patch | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e6965b6-8f08-db62-e063-6394a90a64c9 | 2025-11-26 | Warnings | M016 |
| XIMONTH GLP-1 Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Repair | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 37e40cc1-1121-1eee-e063-6294a90aab26 | 2025-11-26 | Warnings | M016 |
| XIMONTH Liquid Wart Corn Callus Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3a1b872a-2883-0b70-e063-6294a90af9d6 | 2025-11-26 | Warnings | M016 |
| XIMONTH Jimerito Honey For Eyes | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3aa38704-4d2b-ffaf-e063-6294a90a323e | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Honey Eye Drops | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e69c950-bbbc-5c47-e063-6294a90a070e | 2025-11-26 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 4c7e832e-55f3-4766-98b7-29b17d741a4b | 2025-11-26 | Warnings | M016 |
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 43edc287-57e1-d96e-e063-6294a90ac5a1 | 2025-11-24 | Warnings | M016 |
Packages#
| 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 |