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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42192-101DDiscontinued by firm2026-07-31
excluded packagepackage42192-10142192-101-10DDiscontinued by firm2026-07-31

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