Urea 47

Product NDC
58657-488
11-digit product format
586570488
Labeler code
58657
Product ID
58657-488_9ed18606-b9cc-6fac-e053-2a95a90af3ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-03
Marketing end
2020-02-29
Substance
UREA
Active strength
470 mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58657-488DDiscontinued by firm2026-07-31
excluded packagepackage58657-48858657-488-05DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-488-052020-02-17C16284748780-19d75b9d0-62a7-f424-e053-dadaa90a57ceUrea 47
58657-488-052020-01-31C16284748780-19d75b9d0-62a7-f424-e053-dadaa90a57ceUrea 47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-488-05GM - Gram58657-4884ac4c92c-6ca0-4726-9993-dbeed13e389912018-09-05