Utopic
- Product NDC
- 57893-301
- 11-digit product format
- 578930301
- Labeler code
- 57893
- Product ID
- 57893-301_7cedfd8f-2ac1-5db4-e053-2991aa0a9bac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Artesa Labs, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-08-15
- Marketing end
- 0000-00-00
- Substance
- UREA
- Active strength
- 410 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 57893-301 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57893-301 | 57893-301-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57893-301 | 57893-301-08 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57893-301 | 57893-301-09 | D | Discontinued by firm | | 2026-07-31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| UREA | ACTIVE INGREDIENT | 8W8T17847W | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| UREA | ACTIVE MOIETY | 8W8T17847W | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| GLYCERYL STEARATE SE | INACTIVE INGREDIENT | FCZ5MH785I | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | UTOPIC (UREA) CREAM [ARTESA LABS, LLC] | 2 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57893-301-01 | 57893030101 | 10 TUBE in 1 CARTON (57893-301-01) > 4 g in 1 TUBE (57893-301-04) | 10 tube | 2018-02-01 | 0000-00-00 | Yes | No | Current |
| 57893-301-08 | 57893030108 | 227 g in 1 BOTTLE, PLASTIC (57893-301-08) | 227 g | 2011-08-15 | 0000-00-00 | No | No | Current |