Keralac
- Product NDC
- 57883-401
- 11-digit product format
- 578830401
- Labeler code
- 57883
- Product ID
- 57883-401_7cfd83dc-9b9d-3645-e053-2a91aa0ab88c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Brava Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-07-01
- Marketing end
- 0000-00-00
- Substance
- UREA
- Active strength
- 470 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 | 57883-401 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57883-401 | 57883-401-04 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57883-401 | 57883-401-05 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 57883-401 | 57883-401-10 | 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 | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| UREA | ACTIVE MOIETY | 8W8T17847W | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| CAMPHOR (NATURAL) | INACTIVE INGREDIENT | N20HL7Q941 | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) | INACTIVE INGREDIENT | R33S7TK2EP | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC] | 1 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57883-401-04 | 57883040104 | 10 TUBE in 1 CARTON (57883-401-04) > 4 g in 1 TUBE | 10 tube | 2017-09-22 | 0000-00-00 | Yes | No | Current |
| 57883-401-05 | 57883040105 | 142 g in 1 BOTTLE, PLASTIC (57883-401-05) | 142 g | 2011-07-01 | 0000-00-00 | No | No | Current |