FDA.reportPublic FDA data

Urea 40%

Product NDC
39328-019
11-digit product format
393280019
Labeler code
39328
Product ID
39328-019_2a3a53e2-6a1d-4422-b058-c9799cb3fa79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Patrin Pharma, Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-10-01
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 40%
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
53ccf801-c1c6-42c8-a511-da33c308076fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-019-01Urea 40%1 in 1 CARTONCREAM11
39328-019-01Urea 40%28.35 g in 1 BOTTLE, PLASTICCREAM28.351
39328-019-03Urea 40%85 g in 1 BOTTLE, PLASTICCREAM851
39328-019-07Urea 40%198.4 g in 1 BOTTLE, PLASTICCREAM198.41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-019-01GM - Gram39328-0198a1ed534-32af-43c5-9e3c-f053febb83f512025-09-12
39328-019-03GM - Gram39328-019b857813f-e831-4335-9f58-83087e001a0e12025-09-12
39328-019-07GM - Gram39328-01995bfd026-627e-482b-b026-4f8116516d0e12025-09-12

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
Urea 40%UREAPatrin Pharma, Inc53ccf801-c1c6-42c8-a511-da33c308076f2025-08-21Warnings, Adverse reactionsExact identifier
ndc (product): 39328-019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN53ccf801-c1c6-42c8-a511-da33c308076f1
198342urea 400 MG/ML Topical CreamSCD53ccf801-c1c6-42c8-a511-da33c308076f1
198342urea 40 % Topical CreamSY53ccf801-c1c6-42c8-a511-da33c308076f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39328-019-01393280019011 BOTTLE, PLASTIC in 1 CARTON (39328-019-01) / 28.35 g in 1 BOTTLE, PLASTIC2025-10-01NoNoCurrent
39328-019-033932800190385 g in 1 BOTTLE, PLASTIC (39328-019-03) 85 g2025-10-01NoNoCurrent
39328-019-0739328001907198.4 g in 1 BOTTLE, PLASTIC (39328-019-07) 198.4 g2025-10-01NoNoCurrent