FDA.reportPublic FDA data

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 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
351155Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4Available on FDA.report

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

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
UREAUREABantry Pharma, LLCcb6ddbfc-ea6a-0ddc-e053-2995a90aedc42025-06-04Warnings, Adverse reactionsExact identifier
ndc (product): 81542-201

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