FDA.reportPublic FDA data

UREA

Product NDC
50268-872
11-digit product format
502680872
Labeler code
50268
Product ID
50268-872_34145ca3-6034-8c33-e063-6394a90acb55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
AvPAK
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-07-13
Substance
UREA
Active strength
40 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UREAUREAAvPAKe3b31a1c-8be2-29f6-e053-2a95a90af5262025-05-01Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication. To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com ; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Additional Listing Data#

Finished product
Yes
Brand name base
UREA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA40 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-872-19UREA198.4 g in 1 BOTTLECREAM198.44
50268-872-28UREA28.35 g in 1 TUBECREAM28.354
50268-872-85UREA85 g in 1 TUBECREAM854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-872-19GM - Gram50268-8721a371e6c-1190-4221-a9c9-80dab0dbf4d912023-04-07
50268-872-28GM - Gram50268-872ed0097dc-c800-41b8-a195-2633bce7a96d12022-08-04
50268-872-85GM - Gram50268-872c107996f-c90b-4848-840b-c32cc8a74a2612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-872UREA CREAM [AVPAK]4Current NDC, Legacy NDC, 3 package rows20250502_e3b31a1c-8be2-29f6-e053-2a95a90af526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNe3b31a1c-8be2-29f6-e053-2a95a90af5264
198342urea 400 MG/ML Topical CreamSCDe3b31a1c-8be2-29f6-e053-2a95a90af5264
198342urea 40 % Topical CreamSYe3b31a1c-8be2-29f6-e053-2a95a90af5264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-872-1950268087219198.4 g in 1 BOTTLE (50268-872-19) 198.4 g2023-02-24NoNoCurrent
50268-872-285026808722828.35 g in 1 TUBE (50268-872-28) 28.35 g2022-07-130000-00-00NoNoCurrent
50268-872-855026808728585 g in 1 TUBE (50268-872-85) 85 g2023-02-24NoNoCurrent