FDA.reportPublic FDA data

UREA

Product NDC
44523-617
11-digit product format
445230617
Labeler code
44523
Product ID
44523-617_4629c716-aa54-7dc4-e063-6294a90a3dec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-03-15
Substance
UREA
Active strength
400 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UREA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA400 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W8T17847WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198342Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6774a5ef-9bb0-4e7a-e053-2a91aa0af47fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
44523-617-012024-03-06Urea 40% Cream
44523-617-032024-03-06Urea 40% Cream
44523-617-072024-03-06Urea 40% Cream
44523-617-012024-01-30Urea 40% Cream
44523-617-032024-01-30Urea 40% Cream
44523-617-072024-01-30Urea 40% Cream
44523-617-012020-04-28Urea 40% Cream
44523-617-032020-04-28Urea 40% Cream
44523-617-072020-04-28Urea 40% Cream
44523-617-012020-01-31Urea 40% Cream
44523-617-032020-01-31Urea 40% Cream
44523-617-072020-01-31Urea 40% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-617-01UREA1 in 1 CARTONCREAM16
44523-617-01UREA28.35 g in 1 BOTTLE, PLASTICCREAM28.356
44523-617-03UREA85 g in 1 BOTTLE, PLASTICCREAM856
44523-617-07UREA198.4 g in 1 BOTTLE, PLASTICCREAM198.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-617-01GM - Gram44523-61798206e40-aaf9-4816-acf9-a16d3374163f12018-04-19
44523-617-03GM - Gram44523-617a9ec887f-be5a-43af-bbcb-94126b240aed12018-04-19
44523-617-07GM - Gram44523-617fb034714-47f7-40cc-8187-47c508fe0f5d12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-617UREA CREAM [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 4 package rows20240308_6774a5ef-9bb0-4e7a-e053-2a91aa0af47f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UREAUREABioComp Pharma, Inc.6774a5ef-9bb0-4e7a-e053-2a91aa0af47f2025-12-17Warnings, Adverse reactionsExact identifier
ndc (product): 44523-617

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN6774a5ef-9bb0-4e7a-e053-2a91aa0af47f6
198342urea 400 MG/ML Topical CreamSCD6774a5ef-9bb0-4e7a-e053-2a91aa0af47f6
198342urea 40 % Topical CreamSY6774a5ef-9bb0-4e7a-e053-2a91aa0af47f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-617-01445230617011 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTIC2018-03-150000-00-00NoNoCurrent
44523-617-034452306170385 g in 1 BOTTLE, PLASTIC (44523-617-03) 85 g2018-03-150000-00-00NoNoCurrent
44523-617-0744523061707198.4 g in 1 BOTTLE, PLASTIC (44523-617-07) 198.4 g2018-03-150000-00-00NoNoCurrent