Home NDC 52187-549 UREA
Product NDC 52187-549
11-digit product format 521870549
Labeler code 52187
Product ID 52187-549_db83b517-90d6-44f2-e053-2995a90a2cf3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name UREA
Dosage form CREAM
Route TOPICAL
Labeler KMM Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-03-31
Marketing end 0000-00-00
Substance UREA
Active strength 470 mg/g
NDC exclude flag No
Listing certified through 2023-12-31
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 · 4 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 52187-549-05 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 52187-549-05 f5e01cc5f278…a2eaf40c39c3…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52187-549 UREA CREAM [KMM PHARMACEUTICALS, LLC] 2 Legacy NDC 20241213_db83b517-90d5-44f2-e053-2995a90a2cf3.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52187-549-05 52187054905 142 g in 1 BOTTLE, PLASTIC (52187-549-05) 142 g 2022-03-31 0000-00-00 No No Current