Home NDC 42792-101 UREA
Product NDC 42792-101
11-digit product format 427920101
Labeler code 42792
Product ID 42792-101_e71318cb-a690-517b-e053-2a95a90ac97b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name UREA
Dosage form CREAM
Route TOPICAL
Labeler AUSTIN PHARMACEUTICALS, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-03-09
Marketing end 0000-00-00
Substance UREA
Active strength 390 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42792-101-08 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42792-101-08 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42792-101-08 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42792-101-08 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42792-101-08 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42792-101-08 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42792-101-08 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42792-101-08 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42792-101-08 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded UREA ACTIVE INGREDIENT 8W8T17847W UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 UREA ACTIVE MOIETY 8W8T17847W UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT F68VH75CJC UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 DIMETHYL ISOSORBIDE INACTIVE INGREDIENT SA6A6V432S UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE UREA CREAM [AUSTIN PHARMACEUTICALS, LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42792-101-08 42792010108 227 g in 1 BOTTLE (42792-101-08) 227 g 2011-03-09 0000-00-00 No No Current