UREA

Product NDC
81542-201
11-digit product format
815420201
Labeler code
81542
Product ID
81542-201_36c18d8c-6e56-ad83-e063-6294a90a25fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
LOTION
Route
TOPICAL
Labeler
Bantry Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-09-07
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 Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui351155

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81542-201-08UREA226.8 g in 1 BOTTLELOTION226.83

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81542-201-08GM - Gram81542-2010f49285d-8c64-4170-b193-668961c09d6f12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81542-201UREA LOTION [BANTRY PHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20230907_cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351155urea 40 % Topical LotionPSNcb6ddbfc-ea6a-0ddc-e053-2995a90aedc43
351155urea 400 MG/ML Topical LotionSCDcb6ddbfc-ea6a-0ddc-e053-2995a90aedc43
351155urea 40 % Bioadhesive Topical SuspensionSYcb6ddbfc-ea6a-0ddc-e053-2995a90aedc43
351155urea 40 % Topical LotionSYcb6ddbfc-ea6a-0ddc-e053-2995a90aedc43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81542-201-0881542020108226.8 g in 1 BOTTLE (81542-201-08) 226.8 g2021-09-070000-00-00NoNoCurrent