FDA.reportPublic FDA data

Keralac

Product NDC
57883-401
Requested package NDC
57883-401-05
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57883-40157883-401-05DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57883-401-05GM - Gram57883-4012766875d-5f2c-484b-8ea3-9db43d29d0da12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847WKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
UREAACTIVE MOIETY8W8T17847WKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662KERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RKERALAC (UREA) CREAM [BRAVA PHARMACEUTICALS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57883-401-0557883040105142 g in 1 BOTTLE, PLASTIC (57883-401-05) 142 g2011-07-010000-00-00NoNoCurrent