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 |
|---|---|---|---|---|---|---|
| Fresh Scent PROTECTIVE BABY | ZINC OXIDE | CVS Pharmacy, Inc. | 3f33c62c-43ec-4576-a24d-bd5de07e74d2 | 2026-07-23 | Warnings | M016 |
| DERMFREE Vein Target Microneedle Patch | ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57449e29-ec46-9c30-e063-6394a90a7b4a | 2026-07-23 | Warnings | M016 |
| Baby Vitamin A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a125ea-6f9f-310c-e063-6394a90acef2 | 2026-07-22 | Warnings | M016 |
| First Aid A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a319d0-d39a-5ff0-e063-6394a90a671d | 2026-07-22 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | M016 |
| Dermasporin | LANOLIN | Marie's Original Formulas LLC | 562f40aa-eeec-2b7c-e063-6294a90ad68d | 2026-07-22 | Warnings | M016 |
| CAREALL Vitamin A and D | PETROLATUM | New World Imports, Inc | ef89a68a-74c1-4c42-8078-b7a208ace0de | 2026-07-22 | Warnings | M016 |
| Dermact | LANOLIN | Marie's Original Formulas LLC | 57121dbe-e886-a562-e063-6294a90a367f | 2026-07-22 | Warnings | M016 |
| Universal WITCH HAZEL | WITCH HAZEL | Universal Distribution Center LLC | 7e0b56ef-fa41-4862-b387-5b58d81d67d4 | 2026-07-22 | Warnings | M016 |
| Aveeno Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | 0c410b8e-025f-477c-afac-6e2e9ac88f7d | 2026-07-21 | Warnings | M016 |
| DERMFREE SCAR SHEETS | SILICONE GEL 1% SCAR SHEETS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4ce316-4b92-7e81-e063-6294a90af6db | 2026-07-21 | Warnings | M016 |
| DERMFREE VARICOSE VEINS | DIMETHICONE 3% VARICOSE VEINS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5a2d1d-9e84-18eb-e063-6394a90a97ee | 2026-07-21 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 571083ce-cd35-a638-e063-6394a90ae4c7 | 2026-07-20 | Warnings | M016 |
| Mederma Stretch Marks Therapy | DIMETHICONE | PMI Branded Pharmaceuticals, Inc. | 0f2918e3-9615-40e3-ab7e-6bfbe022e03c | 2026-07-16 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | Better Living Brands, LLC | c7ef0ef3-6861-4b94-af4b-371fee8c1f3d | 2026-07-16 | Warnings, Adverse reactions | M016 |
| Dove | MEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BAR | Conopco d/b/a Unilever | 56bd6fcb-c762-4e5a-e063-6394a90a3438 | 2026-07-16 | Warnings | M016 |
| Mederma Advanced Scar | ALLANTOIN | PMI Branded Pharmaceuticals, Inc. | 25bc1eae-3502-4c63-bd8a-43be2dfb0d6d | 2026-07-16 | Warnings | M016 |
| Mederma Advanced Scar | ALLANTOIN | L. Perrigo Company | 9c3d9e08-9428-4b28-82a2-0cb24c3c92a3 | 2026-07-16 | Warnings | M016 |
| aftershave | CERAMIDE NP | Shengnan (Guangzhou) Cosmetics Co., LTD | 56a17ac9-803b-932c-e063-6394a90aae90 | 2026-07-15 | Warnings | M016 |
| Clear Root Labs Wound Care | CRL WOUND CARE OINTMENT | Aidance Scientific Inc. DBA Aidance Skincare & Topicals | 56a6dbc7-5001-c095-e063-6294a90a1aa0 | 2026-07-15 | 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 |