FDA.reportPublic FDA data

UREA

Product NDC
54295-308
Requested package NDC
54295-308-15
11-digit product format
542950308
Labeler code
54295
Product ID
54295-308_b77984dc-97fc-43b2-bd7a-909ebb9ff576
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
Trinity Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-09-01
Marketing end
0000-00-00
Substance
UREA
Active strength
40 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54295-30854295-308-15IInactivated by FDA2026-08-03

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 · 1 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 packagepackage54295-30854295-308-15EExcluded 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
54295-308-152026-01-29C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-242026-01-29C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-252026-01-29C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-152023-03-22C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-242023-03-22C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-252023-03-22C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-152023-01-30C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-242023-01-30C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%
54295-308-252023-01-30C16284748780-1f386c64a-1765-0266-e053-dadaa90a7c1aUrea Cream 40%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54295-308-15UREA1 in 1 CARTONCREAM15
54295-308-15UREA28 g in 1 BOTTLE, PLASTICCREAM285
54295-308-24UREA85 g in 1 BOTTLE, PLASTICCREAM855
54295-308-24UREA1 in 1 CARTONCREAM15
54295-308-25UREA1 in 1 CARTONCREAM15
54295-308-25UREA198 g in 1 BOTTLE, PLASTICCREAM1985

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54295-308-15GM - Gram54295-308f0292d54-9d03-477f-823e-91701daa8cf512014-11-05
54295-308-24GM - Gram54295-3082b2db6f1-c7c8-419d-9298-de031402ad1812014-11-05
54295-308-25GM - Gram54295-308d5469ca5-fc1d-44fb-9a69-426993dce9a312014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847WUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
UREAACTIVE MOIETY8W8T17847WUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4UREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEUREA CREAM [TRINITY PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54295-308UREA (UREA) CREAM [TRINITY PHARMACEUTICALS, LLC]5Legacy NDC, 6 package rows20230323_ba6f162b-98ac-43a8-b098-ac08a428c91f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNba6f162b-98ac-43a8-b098-ac08a428c91f5
198342urea 400 MG/ML Topical CreamSCDba6f162b-98ac-43a8-b098-ac08a428c91f5
198342urea 40 % Topical CreamSYba6f162b-98ac-43a8-b098-ac08a428c91f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54295-308-15542950308151 BOTTLE, PLASTIC in 1 CARTON (54295-308-15) > 28 g in 1 BOTTLE, PLASTIC2014-09-010000-00-00NoNoCurrent