FDA.reportPublic FDA data

UREA

Product NDC
54295-311
11-digit product format
542950311
Labeler code
54295
Product ID
54295-311_843930fc-2fd8-4308-83ec-68edd74f8674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
Trinity Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-12-02
Marketing end
0000-00-00
Substance
UREA
Active strength
39 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct54295-311IInactivated by FDA2026-08-17
excluded packagepackage54295-31154295-311-18IInactivated by FDA2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct54295-311EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54295-31154295-311-18EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54295-311-182026-01-29C16284748780-1f386c649-b66f-0266-e053-dadaa90a7c1aUrea Cream 39%
54295-311-182023-03-22C16284748780-1f386c649-b66f-0266-e053-dadaa90a7c1aUrea Cream 39%
54295-311-182023-01-30C16284748780-1f386c649-b66f-0266-e053-dadaa90a7c1aUrea Cream 39%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54295-311-18UREA1 in 1 CARTONCREAM16
54295-311-18UREA227 g in 1 BOTTLE, PLASTICCREAM2276

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54295-311-18GM - Gram54295-3113aa9fc4e-ffb8-4c71-9b5f-8062675d558a12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847WUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
UREAACTIVE MOIETY8W8T17847WUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4UREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEUREA CREAM [TRINITY PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54295-311UREA (UREA) CREAM [TRINITY PHARMACEUTICALS, LLC]6Legacy NDC, 2 package rows20230323_2e1cdb54-949f-4a18-bbec-6265c9b3bbd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093289urea 39 % Topical CreamPSN11cb2ff3-464a-4554-a39c-bae9f0ee456b102
1093289urea 390 MG/ML Topical CreamSCD11cb2ff3-464a-4554-a39c-bae9f0ee456b102
1093289urea 39 % Topical CreamSY11cb2ff3-464a-4554-a39c-bae9f0ee456b102
1093289urea 39 % Topical CreamPSN2e1cdb54-949f-4a18-bbec-6265c9b3bbd36
1093289urea 390 MG/ML Topical CreamSCD2e1cdb54-949f-4a18-bbec-6265c9b3bbd36
1093289urea 39 % Topical CreamSY2e1cdb54-949f-4a18-bbec-6265c9b3bbd36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54295-311-18542950311181 BOTTLE, PLASTIC in 1 CARTON (54295-311-18) > 227 g in 1 BOTTLE, PLASTIC2013-12-020000-00-00NoNoCurrent