FDA.reportPublic FDA data

Uremol 20% cream

Product NDC
61344-455
Requested package NDC
61344-455-50
11-digit product format
613440455
Labeler code
61344
Product ID
61344-455_eec7c056-ad53-6346-e053-2a95a90a5375
Type
HUMAN OTC DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Odan Laboratories Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-31
Marketing end
0000-00-00
Substance
UREA
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage61344-45561344-455-50DDiscontinued by firm2026-07-31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61344-455-5061344045550225 g in 1 TUBE (61344-455-50) 225 g2019-05-310000-00-00NoNoCurrent