Home NDC 50096-501 Urea 47% Cream
Product NDC 50096-501
11-digit product format 500960501
Labeler code 50096
Product ID 50096-501_7cec1e16-8165-13c7-e053-2991aa0ae0f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name UREA
Dosage form CREAM
Route TOPICAL
Labeler Rosemar Labs, 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50096-501-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50096-501-05 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50096-501-05 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50096-501-05 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50096-501-05 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50096-501-05 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50096-501-05 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50096-501-05 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50096-501-05 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50096-501-05 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50096-501-05 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50096-501-05 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded UREA ACTIVE INGREDIENT 8W8T17847W UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 UREA ACTIVE MOIETY 8W8T17847W UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) INACTIVE INGREDIENT R33S7TK2EP UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R UREA 47% CREAM (UREA) CREAM [ROSEMAR LABS, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50096-501-05 50096050105 142 g in 1 BOTTLE, PLASTIC (50096-501-05) 142 g 2011-07-01 0000-00-00 No No Current