FDA.reportPublic FDA data

Urea

Product NDC
52191-351
Requested package NDC
52191-351-08
11-digit product format
521910351
Labeler code
52191
Product ID
52191-351_69ac5657-d5b3-1abc-e053-2991aa0a26d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
Bowyn Labs, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-04-12
Marketing end
0000-00-00
Substance
UREA
Active strength
410 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 packagepackage52191-35152191-351-08DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52191-351-08GM - Gram52191-351a7affc9d-aab0-4e6e-be08-e1c0ff3ab75012018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52191-351-0852191035108227 g in 1 BOTTLE, PLASTIC (52191-351-08) 227 g2018-04-120000-00-00NoNoCurrent