UREA
- Product NDC
- 42808-202
- 11-digit product format
- 428080202
- Labeler code
- 42808
- Product ID
- 42808-202_ecacf984-65d2-8a10-e053-2a95a90a0f0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Exact-Rx, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-08-01
- Marketing end
- 0000-00-00
- Substance
- UREA
- Active strength
- 450 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| UREA | ACTIVE INGREDIENT | 8W8T17847W | UREA CREAM [EXACT-RX, INC.] | 1 | |
| UREA | ACTIVE MOIETY | 8W8T17847W | UREA CREAM [EXACT-RX, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | UREA CREAM [EXACT-RX, INC.] | 1 | |
| CAMPHOR (SYNTHETIC) | INACTIVE INGREDIENT | 5TJD82A1ET | UREA CREAM [EXACT-RX, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | UREA CREAM [EXACT-RX, INC.] | 1 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | UREA CREAM [EXACT-RX, INC.] | 1 | |
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | UREA CREAM [EXACT-RX, INC.] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | UREA CREAM [EXACT-RX, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | UREA CREAM [EXACT-RX, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | UREA CREAM [EXACT-RX, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | UREA CREAM [EXACT-RX, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42808-202 | UREA CREAM [EXACT-RX, INC.] | 9 | Legacy NDC | 20241225_e4516083-fb4d-4550-a6d7-31fb5bb93a24.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42808-202-09 | 42808020209 | 1 TUBE in 1 CARTON (42808-202-09) > 255 g in 1 TUBE | 1 tube | 2011-08-01 | 0000-00-00 | No | No | Current |