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 |
|---|---|---|---|---|---|---|
| Cetaphil Soothing Gel Cream | ALLANTOIN | Galderma Laboratories, L.P. | bab404f0-2f7a-4bac-b053-cbdc81c029b5 | 2025-11-24 | Warnings | M016 |
| health beyond VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | de87da51-cf92-402c-b60f-5f28d1724124 | 2025-11-23 | Warnings | M016 |
| Medline | WHITE PETROLATUM | Medline Industries, LP | 00766a7b-797e-dd15-e063-6394a90af9ac | 2025-11-20 | Warnings | M016 |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | M016 |
| Moisture Barrier Cream | PETROLATUM, ZINC OXIDE | Derma Sciences Canada Inc. | 43e01e22-7872-8e24-e063-6394a90a17ef | 2025-11-18 | Warnings | M016 |
| terrasil Bed Sore and Pressure Sore Relief | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | d0e4a492-f833-4e92-bd4a-b0a07ce9a69e | 2025-11-18 | Warnings | M016 |
| terrasil Foot Ulcer and Sore Relief | ALLANTOIN | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2776080b-3ddb-ad6c-e063-6394a90a93e0 | 2025-11-18 | Warnings | M016 |
| After Bite Kids | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 226c1420-d771-204f-e063-6294a90af9f6 | 2025-11-18 | Warnings | M016 |
| Petroleum with Cocoa | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 280d4bdb-30d3-44f2-9159-3aa9a1de9a5f | 2025-11-17 | Warnings | M016 |
| After Bite X Tech | SODIUM BICARBONATE | Adventure Ready Brands | e9e49ab4-3e1f-9fd4-e053-2a95a90a775a | 2025-11-17 | Warnings | M016 |
| Diaper Rash skin protectant | LANOLIN AND PETROLATUM | Universal Distribution Centre LLC | 29b5475d-6085-cfe6-e063-6294a90a7e74 | 2025-11-17 | Warnings | M016 |
| DERMOGEN | ZINC OXIDE | KRAMER NOVIS | 38e02d1c-c143-4da6-ad32-a3ce2861aac5 | 2025-11-14 | Warnings | M016 |
| Welmedix HomeCare PRO Rapid Relief Rash Cream | PETROLATUM, ZINC OXIDE | Welmedix LLC | 4382a6b4-0b1f-0822-e063-6394a90adffc | 2025-11-14 | Warnings | M016 |
| Petroleum with Cocoa | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 086b6563-cb73-4874-aa42-028f5e81b60d | 2025-11-13 | Warnings | M016 |
| Welmedix HomeCare PRO Fragile Skin Protectant | PETROLATUM | Welmedix LLC | 43840785-3640-9813-e063-6394a90a7770 | 2025-11-13 | Warnings | M016 |
| Petroleum Jelly Baby Fresh Scent 3.53oz | PETROLATUM | Rejoice International Corp. | 1309926f-ecd9-635e-e063-6294a90aaab3 | 2025-11-11 | Warnings | M016 |
| Petroleum Jelly Fragrance Free 3.53oz | PETROLATUM | Rejoice International Corp. | 12f8d9cc-aa77-e034-e063-6394a90a94dd | 2025-11-11 | Warnings | M016 |
| Petroleum Jelly Cocoa Butter Scent 3.53oz | PETROLATUM | Rejoice International Corp. | 1309b15b-5236-6e9f-e063-6294a90afe11 | 2025-11-11 | Warnings | M016 |
| ODLUMIVIE Tremella Revitalizing Cleanser | TREMELLA FUCIFORMIS WHOLE | ODLUMIVIE | 435e4736-bcef-c227-e063-6394a90a53d5 | 2025-11-11 | Warnings | M016 |
| ODLUMIVIE Peptide CalmMist | PALMITOYL TRIPEPTIDE-8 | ODLUMIVIE | 435e6717-5fbf-5cb2-e063-6294a90a40d7 | 2025-11-11 | 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 |