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.
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Anubis Barcelona New Even | LACTIC ACID, CITRIC ACID, GLYCOLIC ACID | ANUBIS COSMETICS SL | eaeeb6e0-5322-20c4-e053-2995a90a9fd9 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Vital Line | HYDROLYZED COLLAGEN | ANUBIS COSMETICS SL | f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 | 2023-08-29 | Warnings | M016 |
| Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 | CAMPHOR (SYNTHETIC), PETROLATUM | Carma Laboratories, Inc. | 5378d653-702d-405c-a067-882554aaf93a | 2023-08-21 | Warnings | M016 |
| Quality Choice Anti-itch Medicated | CALAMINE AND PRAMOXINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 5e07f26f-cfb6-57f9-e053-2991aa0a2008 | 2023-08-02 | Warnings | M016 |
| Barrier Balm | BARRIER BALM | Autumn Harp, Inc. | 01df9746-991b-4363-e063-6294a90aaac6 | 2023-08-01 | Warnings | M016 |
| Barrier Cream | ZINC OXIDE | Avasol LLC | bc6a2736-faa6-46d3-af9b-a70f0762e9ce | 2023-05-15 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | bec2f702-5ff5-ea66-e053-2a95a90ad1ec | 2023-01-01 | Warnings | M016 |
| Badger After-BUG Balm | COLLOIDAL OATMEAL | W.S. Badger Company, Inc. | a623da47-cef2-146f-e053-2a95a90afe3a | 2021-11-17 | Warnings | M016 |
| Derma-e Eczema Relief | OATMEAL | Topiderm, Inc | e1797f81-af4b-49e1-9906-dbfd904a282b | 2020-08-19 | Warnings | M016 |
| Resurfix Plus | PETROLATUM | Topiderm, Inc. | f100f43d-6ace-4c3a-9c85-640c0ab2e360 | 2019-11-19 | 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 |