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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pediadermics eczema 3
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 3.36 g/168g |
| OATMEAL | .168 g/168g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O, 8PI54V663Y |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76348-580 | PEDIADERMICS ECZEMA 3 (COLLOIDAL OATMEAL, DIMETHICONE) CREAM [RENU LABORATORIES, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250419_af861f0b-4387-6861-e053-2995a90a8bfa.zip |
Packages#
Package NDC, 11-digit format, Description table| 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 |