CEM-Urea
- Product NDC
- 42546-100
- 11-digit product format
- 425460100
- Labeler code
- 42546
- Product ID
- 42546-100_2267e100-a474-4423-8f46-3458a9e5e221
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- urea
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- PruGen, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-07-01
- Marketing end
- 0000-00-00
- Substance
- UREA
- Active strength
- 0 mL/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42546-100-20 | CEM-Urea | 20 mL in 1 APPLICATOR | SOLUTION | 20 | | 1 |
| 42546-100-20 | CEM-Urea | 1 in 1 BOX | SOLUTION | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| UREA | ACTIVE INGREDIENT | 8W8T17847W | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| UREA | ACTIVE MOIETY | 8W8T17847W | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| CAMPHOR (SYNTHETIC) | INACTIVE INGREDIENT | 5TJD82A1ET | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) | INACTIVE INGREDIENT | 7Q6P4JN1QT | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42546-100 | CEM-UREA (UREA) SOLUTION [PRUGEN, INC.] | 1 | Legacy NDC, 2 package rows | 20111014_697b1730-b716-444f-8671-934f47ae21bd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 42546-100-20 | 42546010020 | 20 mL in 1 APPLICATOR | 20 ml | Historical |