FDA.reportPublic FDA data

Urea Cream 40%

Product NDC
0904-7167
Requested package NDC
0904-7167-83
11-digit product format
009047167
Labeler code
0904
Product ID
0904-7167_c6a097be-a462-6476-e053-2995a90a1788
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Major Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-07-06
Marketing end
0000-00-00
Substance
UREA
Active strength
400 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage0904-71670904-7167-83DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7167-23GM - Gram0904-7167719abb33-9fe9-4b58-9edd-8e2f21d1798312021-09-07
0904-7167-83GM - Gram0904-7167dd42c449-7c7f-4653-96bb-ef3780af9d7f12021-09-07
0904-7167-99GM - Gram0904-71672d799714-e0e2-49a8-853a-49d3a846be9812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7167UREA CREAM 40% (UREA) CREAM [MAJOR PHARMACEUTICALS]3Legacy NDC20231007_c6a097be-a461-6476-e053-2995a90a1788.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7167-83009047167831 BOTTLE, PLASTIC in 1 CARTON (0904-7167-83) > 85 g in 1 BOTTLE, PLASTIC2021-07-060000-00-00NoNoCurrent