UREA

Product NDC: 71399-8455
11-digit product format: 713998455
Labeler code: 71399
Product ID: 71399-8455_ce61c92f-c0eb-4f9b-9b7f-98cb72499e1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: UREA
Dosage form: LOTION
Route: TOPICAL
Labeler: AKRON PHARMA INC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2024-09-13
Substance: UREA
Active strength: 40 g/100g
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
Ingredient	Strength
UREA	40 g/100g

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
351155	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
3c0d612a-2247-448d-ae65-f9abfd894158	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71399-8455-8	2023-03-26	C162847	48780-1	f386c64a-3b41-0266-e053-dadaa90a7c1a	Urea Lotion 40%
71399-8455-8	2023-01-30	C162847	48780-1	f386c64a-3b41-0266-e053-dadaa90a7c1a	Urea Lotion 40%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71399-8455-8	UREA	227 g in 1 BOTTLE	LOTION	227		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-8455-8	GM - Gram	71399-8455	1870219b-f085-4f16-ba84-9295d9ac0ffc	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71399-8455	UREA (UREA) LOTION [AKRON PHARMA INC]	3	Current NDC, Legacy NDC, 1 package rows	20240927_3c0d612a-2247-448d-ae65-f9abfd894158.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	UREA	AKRON PHARMA INC	3c0d612a-2247-448d-ae65-f9abfd894158	2024-09-25	Warnings, Adverse reactions	Exact identifier ndc (product): 71399-8455

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
351155	urea 40 % Topical Lotion	PSN	3c0d612a-2247-448d-ae65-f9abfd894158	3
351155	urea 400 MG/ML Topical Lotion	SCD	3c0d612a-2247-448d-ae65-f9abfd894158	3
351155	urea 40 % Bioadhesive Topical Suspension	SY	3c0d612a-2247-448d-ae65-f9abfd894158	3
351155	urea 40 % Topical Lotion	SY	3c0d612a-2247-448d-ae65-f9abfd894158	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71399-8455-8	71399845508	227 g in 1 BOTTLE (71399-8455-8)	227 g	2024-09-13	0000-00-00	No	No	Current