UREA
- Product NDC
- 42792-101
- 11-digit product format
- 427920101
- Labeler code
- 42792
- Product ID
- 42792-101_e71318cb-a690-517b-e053-2a95a90ac97b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- AUSTIN PHARMACEUTICALS, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-03-09
- Marketing end
- 0000-00-00
- Substance
- UREA
- Active strength
- 390 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 42792-101 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 42792-101 | 42792-101-08 | 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 | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| UREA | ACTIVE MOIETY | 8W8T17847W | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | F68VH75CJC | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| DIMETHYL ISOSORBIDE | INACTIVE INGREDIENT | SA6A6V432S | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | UREA CREAM [AUSTIN PHARMACEUTICALS, 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 |
|---|
| 42792-101-08 | 42792010108 | 227 g in 1 BOTTLE (42792-101-08) | 227 g | 2011-03-09 | 0000-00-00 | No | No | Current |