Urea 39% Cream

Product NDC: 44523-801
Requested package NDC: 44523-801-08
11-digit product format: 445230801
Labeler code: 44523
Product ID: 44523-801_4846ec49-3653-db3d-e063-6294a90aa815
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Urea 39% Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: BioComp Pharma, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2022-09-23
Substance: UREA
Active strength: 390 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Urea 39% Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UREA	390 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8W8T17847W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1093289	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e79004b9-ffbc-3d06-e053-2995a90a8cd7	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44523-801-08	2024-03-06	C162847	48780-1	1030e365-5bc4-111a-e063-dadaa90a10e2	UREA CREAM 39%
44523-801-08	2024-01-30	C162847	48780-1	1030e365-5bc4-111a-e063-dadaa90a10e2	UREA CREAM 39%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44523-801-08	Urea 39% Cream	227 g in 1 BOTTLE	CREAM	227		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44523-801-08	GM - Gram	44523-801	b01b6262-a573-437c-9295-23f89ec58cd7	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44523-801	UREA 39% CREAM CREAM [BIOCOMP PHARMA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240308_e79004b9-ffbc-3d06-e053-2995a90a8cd7.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Urea 39% Cream	UREA 39% CREAM	BioComp Pharma, Inc.	e79004b9-ffbc-3d06-e053-2995a90a8cd7	2026-01-13	Warnings, Adverse reactions	Exact identifier ndc (package): 44523-801-08 ndc (product): 44523-801 ndc11 (package): 44523080108

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8W8T17847W	UREA	57-13-6	UREA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1093289	urea 39 % Topical Cream	PSN	e79004b9-ffbc-3d06-e053-2995a90a8cd7	3
1093289	urea 390 MG/ML Topical Cream	SCD	e79004b9-ffbc-3d06-e053-2995a90a8cd7	3
1093289	urea 39 % Topical Cream	SY	e79004b9-ffbc-3d06-e053-2995a90a8cd7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44523-801-08	44523080108	227 g in 1 BOTTLE (44523-801-08)	227 g	2022-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UREA CREAM 39%	BioComp Pharma, Inc. \| Mission Pharmacal Company	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	3