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 |
|---|---|---|---|---|---|---|
| NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN | ZINC OXIDE | Bentley Laboratories, LLC | 7920708a-6fa7-4bc8-94ba-096e77d9d7e1 | 2024-12-27 | Warnings | M016 |
| AD Medicated Rash | AD MEDICATED RASH | WellSpring Pharmaceutical Corporation | aac345bf-ea66-4f5b-a497-c24ea72f93ea | 2024-12-27 | Warnings | M016 |
| ZO Skin Health Post Procedure Recovery System | ALUMINUM ACETATE | ZO Skin Health, Inc. | 3b977415-2bf4-43a9-bb48-1eb023ca4f53 | 2024-12-27 | Warnings | M016 |
| terrasil Scar Recovery | ALLANTOIN | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2a2f91ff-a447-9d2a-e063-6394a90a84f8 | 2024-12-26 | Warnings | M016 |
| WITCH HAZEL | WITCH HAZEL | CHAIN DRUG MARKETING ASSOCIATION INC | bdccee3f-0ad8-4264-a65f-ae86aed6bf03 | 2024-12-26 | Warnings | M016 |
| All Over Lavender Rosemary | COLLOIDAL OAT OINTMENT | Tubby Todd | 29f46671-7467-95c9-e063-6294a90a1354 | 2024-12-23 | Warnings | M016 |
| Sweet Cheeks Diaper Sprayer | ZINC OXIDE DIAPER PASTE SPRAY | Tubby Todd | 29f4aa3c-d10e-52a5-e063-6294a90acc4b | 2024-12-23 | Warnings | M016 |
| calamine | CALAMINE AND ZINC OXIDE | WALGREEN COMPANY | fed3026b-3473-26fe-e053-6294a90a8aa2 | 2024-12-23 | Warnings | M016 |
| CUREFINI | PETROLATUM, COD LIVER OIL | Miramar Cosmetics, Inc DBA Miramar Lab | fc9211db-71aa-44d8-a00b-65f1482d3981 | 2024-12-23 | Warnings | M016 |
| CUREFINI | PETROLATUM | Miramar Cosmetics, Inc DBA Miramar Lab | 6a2610ca-ca80-451f-8fed-b982443a10b9 | 2024-12-23 | Warnings | M016 |
| Vitamin A and D | LANOLIN, PETROLATUM | Trifecta Pharmaceuticals USA LLC | 453dffec-de9d-0eac-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| Vitamin A and D | LANOLIN, PETROLATUM | Trifecta Pharmaceuticals USA LLC | 455a16fd-9ce5-6bef-e054-00144ff88e88 | 2024-12-20 | Warnings | M016 |
| White Petrolatum | PETROLATUM | Trifecta Pharmaceuticals USA LLC | f1eb0ec2-98e7-13a2-e053-2a95a90a2938 | 2024-12-20 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Pharmacy Value Alliance, LLC | 38018e3f-3778-01d1-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| DiaperRashOintment | ZINC OXIDE | Pharmacy Value Alliance, LLC | 3aace6d8-d24c-00e1-e054-00144ff8d46c | 2024-12-20 | Warnings | M016 |
| Medicated Body Powder | MENTHOL | New Pride Corp | f0f0e332-cb93-42a7-e053-2995a90ac4ae | 2024-12-19 | Warnings | M016 |
| Health Smart Medicated Body | MENTHOL AND ZINC OXIDE | International Wholesale Inc dba Home Smart Products | 044870e2-ebac-a095-e063-6294a90a2751 | 2024-12-19 | Warnings | M016 |
| White Rain Original Petroleum | WHITE PETROLEUM | INTERNATIONAL WHOLESALE INC. | d6ebe00c-b692-5171-e053-2a95a90a976c | 2024-12-19 | Warnings | M016 |
| Health Smart Original Petroleum | WHITE PETROLEUM | Home Smart Products | aedf746f-4c49-421d-a666-1ba02e8fb17d | 2024-12-19 | Warnings | M016 |
| white rain Cocoa Butter Petroleum Jelly | WHITE PETROLATUM | INTERNATIONAL WHOLESALE INC. | d7068e2b-c3b2-d16d-e053-2a95a90a6dd2 | 2024-12-19 | 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 |