UREA

Product NDC
42192-101
11-digit product format
421920101
Labeler code
42192
Product ID
42192-101_68920cfc-04e7-facf-e053-2a91aa0a62af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
EMULSION
Route
TOPICAL
Labeler
ACELLA PHARMACEUTICALS
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-06-29
Marketing end
0000-00-00
Substance
UREA
Active strength
50 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42192-101DDiscontinued by firm2026-08-17
excluded packagepackage42192-10142192-101-10DDiscontinued by firm2026-08-17

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42192-101-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42192-101-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42192-101-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42192-101-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42192-101-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42192-101-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42192-101-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42192-101-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42192-101-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42192-101-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42192-101-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42192-101-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42192-101-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42192-101-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42192-101-10IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42192-101-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42192-101-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42192-101-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42192-101-102023-09-19C16284748780-19d75b9d1-01a4-f424-e053-dadaa90a57ce50% UREA EMULSION
42192-101-102020-01-31C16284748780-19d75b9d1-01a4-f424-e053-dadaa90a57ce50% UREA EMULSION

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-101-10GM - Gram42192-101a5b74611-65e9-46a1-b9f4-bafd587e85ed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847WUREA EMULSION [ACELLA PHARMACEUTICALS]2
UREAACTIVE MOIETY8W8T17847WUREA EMULSION [ACELLA PHARMACEUTICALS]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1UREA EMULSION [ACELLA PHARMACEUTICALS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNUREA EMULSION [ACELLA PHARMACEUTICALS]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KUREA EMULSION [ACELLA PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUREA EMULSION [ACELLA PHARMACEUTICALS]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATUREA EMULSION [ACELLA PHARMACEUTICALS]2
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJUREA EMULSION [ACELLA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQUREA EMULSION [ACELLA PHARMACEUTICALS]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MUREA EMULSION [ACELLA PHARMACEUTICALS]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MUREA EMULSION [ACELLA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UREA EMULSION [ACELLA PHARMACEUTICALS]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XUREA EMULSION [ACELLA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUREA EMULSION [ACELLA PHARMACEUTICALS]2
TRICAPRININACTIVE INGREDIENTO1PB8EU98MUREA EMULSION [ACELLA PHARMACEUTICALS]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKUREA EMULSION [ACELLA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RUREA EMULSION [ACELLA PHARMACEUTICALS]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEUREA EMULSION [ACELLA PHARMACEUTICALS]2
ZINC UNDECYLENATEINACTIVE INGREDIENT388VZ25DURUREA EMULSION [ACELLA PHARMACEUTICALS]2