UREA HYDRATING TOPICAL
- Product NDC
- 42192-115
- 11-digit product format
- 421920115
- Labeler code
- 42192
- Product ID
- 42192-115_68900b38-ea80-dbe3-e053-2a91aa0ade35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Acella Pharmaceuticals
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2010-05-21
- Marketing end
- 0000-00-00
- Substance
- UREA
- Active strength
- 35 g/100g
- 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 | 42192-115 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 42192-115 | 42192-115-15 | 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 HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| UREA | ACTIVE MOIETY | 8W8T17847W | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| BUTANE | INACTIVE INGREDIENT | 6LV4FOR43R | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| PROPANE | INACTIVE INGREDIENT | T75W9911L6 | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS] | 4 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42192-115-15 | 42192011515 | 150 g in 1 CANISTER (42192-115-15) | 150 g | 2010-05-21 | 0000-00-00 | No | No | Current |