FDA.reportPublic FDA data

UREA

Product NDC
54295-312
11-digit product format
542950312
Labeler code
54295
Product ID
54295-312_3f888997-18e8-4af1-817b-4011376ac955
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
LOTION
Route
TOPICAL
Labeler
Trinity Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-09-19
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54295-312-182023-03-22C16284748780-1d6a99b39-4d29-a426-e053-dadaa90af4c2Urea Lotion 40%
54295-312-182022-01-28C16284748780-1d6a99b39-4d29-a426-e053-dadaa90af4c2Urea Lotion 40%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54295-312-18UREA1 in 1 CARTONLOTION15
54295-312-18UREA227 g in 1 BOTTLE, PLASTICLOTION2275

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54295-312-18GM - Gram54295-312bcceb88a-f10d-4c9a-b7ca-09db7a3e1aa012014-10-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54295-312UREA (UREA) LOTION [TRINITY PHARMACEUTICALS, LLC]5Legacy NDC, 2 package rows20230323_a3d5241c-eb3d-4775-92a9-620b8a623498.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351155urea 40 % Topical LotionPSN1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 400 MG/ML Topical LotionSCD1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 40 % Bioadhesive Topical SuspensionSY1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 40 % Topical LotionSY1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 40 % Topical LotionPSNa3d5241c-eb3d-4775-92a9-620b8a6234985
351155urea 400 MG/ML Topical LotionSCDa3d5241c-eb3d-4775-92a9-620b8a6234985
351155urea 40 % Bioadhesive Topical SuspensionSYa3d5241c-eb3d-4775-92a9-620b8a6234985
351155urea 40 % Topical LotionSYa3d5241c-eb3d-4775-92a9-620b8a6234985

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54295-312-18542950312181 BOTTLE, PLASTIC in 1 CARTON (54295-312-18) > 227 g in 1 BOTTLE, PLASTIC2014-09-190000-00-00NoNoCurrent