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 |
|---|---|---|---|---|---|---|
| Aveeno Daily Moisturizing | DIMETHICONE | Kenvue Brands LLC | 70593b0c-c41b-4294-9bfa-42003ba1e3e4 | 2024-11-05 | Warnings | M016 |
| Aveeno Baby Calming Comfort | DIMETHICONE | Kenvue Brands LLC | 029fbae2-06ad-4fe9-b542-834686c5cb97 | 2024-11-05 | Warnings | M016 |
| Aveeno Skin Relief Overnight | DIMETHICONE | Kenvue Brands LLC | e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c | 2024-11-05 | Warnings | M016 |
| Quality Choice Diaper Rash | ZINC OXIDE | Chain Drug Marketing Association Inc. | 262e7eac-4b44-f224-e063-6394a90a4f59 | 2024-11-05 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Chain Drug Marketing Association Inc. | 262f8cab-c7b8-b07e-e063-6294a90a1289 | 2024-11-05 | Warnings | M016 |
| ECZEMA | OATMEAL | ORGANIC & SUSTAINABLE BEAUTY | 926706b5-0a08-4604-b5ad-3b3ddfd7f02d | 2024-11-05 | Warnings | M016 |
| Walgreens Eczema Relief Body Skin Protectant | OATMEAL | Walgreen Company | b2eebc2f-addd-4822-b224-04bd5f450653 | 2024-11-05 | Warnings | M016 |
| ECZEMA | OATMEAL | ORGANIC & SUSTAINABLE BEAUTY | 81eb3df4-5beb-45aa-82ca-e8b4b37e45f4 | 2024-11-05 | Warnings, Adverse reactions | M016 |
| Aveeno Baby Calming Comfort | DIMETHICONE | Kenvue Brands LLC | 567b1481-b783-45f9-af38-5630c9edf044 | 2024-11-01 | Warnings | M016 |
| ZO Skin Health Astringent Solution | ALUMINUM ACETATE | ZO Skin Health, Inc. | cb801d7e-52ad-6c16-e053-2a95a90a7a1f | 2024-10-31 | Warnings | M016 |
| ZINC OXIDE PHARMA | ZINC OXIDE | ALLIED TRADE LINK LLC | 1b580bf6-f217-5c0f-e063-6294a90a012e | 2024-10-29 | Warnings | M016 |
| Dove DermaSeries Eczema Relief Soothing Body | COLLOIDAL OATMEAL | Conopco, Inc. d/b/a/ Unilever | 59f737f6-dd3f-4b63-b13e-2345cb9a951a | 2024-10-24 | Warnings | M016 |
| Dove | HAND SANITIZER SHEA BUTTER | Conopco Inc. d/b/a/ Unilever | a735d885-bacd-0f5c-e053-2a95a90ad14a | 2024-10-24 | Warnings | M016 |
| Baby Dove | 8H MOISTURIZATION HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | b8dc481c-1ac3-2d63-e053-2a95a90a44f5 | 2024-10-24 | Warnings | M016 |
| Vaseline | CLINICAL CARE HAND SANITIZER LOTION | Conopco Inc. d/b/a/ Unilever | ba0aa323-8887-597f-e053-2995a90a2077 | 2024-10-24 | Warnings | M016 |
| Dove | NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION | Conopco Inc. d/b/a/ Unilever | d1039316-3ca8-90f8-e053-2995a90a2061 | 2024-10-24 | Warnings | M016 |
| Dove | HAND SANITIZER LAVENDER | Conopco Inc. d/b/a/ Unilever | a736838b-b559-f066-e053-2995a90a90f5 | 2024-10-24 | Warnings | M016 |
| Diaper Rash Cream 2.5oz | ZINC OXIDE | Rejoice International Corp. | 130d94d8-ad98-d61f-e063-6294a90a76b0 | 2024-10-21 | Warnings | M016 |
| HARMON DAILY MOISTURZIER | DIMETHICONE | HARMON STORES, INC. | bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7 | 2024-10-21 | Warnings | M016 |
| Dimethicone | BODY SHIELD | McKesson | 8febb45d-a200-702c-e053-2995a90a3e62 | 2024-10-18 | 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 |