FDA-filed SPL labeling · retrieved through openFDA

Urea

Urea is a topical ingredient used across multiple creams, gels, and foam products to treat dry and thickened skin conditions — including eczema, psoriasis, calluses, and damaged nails.

Brand names AluveaCEM-UreaUtopicKera-42Kera Nail +11 more
Rx/OTC Forms 6 Routes Topical · Cutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 42 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 3, 2025
Clinical labels in scope ⓘ42
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1996
FDA-listed product records ⓘ115
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
⭐ Urea at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Urea is a well-established topical ingredient that helps soften and smooth thickened, dry, or scaly skin and damaged nails — with products ranging from creams and gels to foam formulations. It is generally applied to the affected area once or twice daily depending on the product. It's safe and effective when used as directed on the skin, but keep it away from eyes and mouth, and check with your provider if you're pregnant or breastfeeding.
How we write & review this content — our editorial policy →

📖 Urea: Patient Information Guide

A plain-language walkthrough of Urea — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Urea is a topical ingredient found in multiple creams, gels, and foam products used to treat thickened, rough, or damaged skin and nails. Supported uses across the available products include:

  • Dry, rough skin and xerosis (severely dry skin)
  • Dermatitis (skin inflammation)
  • Psoriasis (scaly, inflamed skin patches)
  • Ichthyosis (a condition causing very dry, scaly skin)
  • Eczema
  • Keratosis pilaris and keratosis palmaris (rough, bumpy skin texture)
  • Keratoderma (thickened skin on the palms or soles)
  • Corns and calluses
  • Damaged, ingrown, or devitalized (unhealthy) nails
  • Debridement (removal of dead tissue) of skin wounds where healing is slowed by infection, dead tissue, or debris
  • Avenaster Fungal Nail Care Duo Set (day) is specifically used to soften thickened toenails, brittle nails, and dry or peeling skin around nails related to tinea pedis
  • MILKBODyLotion is used for general skin moisturization and hydration
⚙️How it works▾

Urea works by gently breaking down the intracellular matrix — the "glue" that holds together the tough, dead outer layers of skin. This loosens the hardened outer skin layer, allowing it to shed more normally and leaving the skin underneath softer and smoother. When applied to nails, this same action helps soften thickened or abnormal nail tissue. The precise molecular mechanism of topically applied urea is still being studied.

💊How it's taken▾

Urea topical products are applied directly to affected skin or nails — never taken by mouth. Most creams are used twice daily, rubbed in until fully absorbed, or as directed by your healthcare provider. Evara, Dermacure, and Uracin 20%, for example, follow this twice-daily routine for both skin and nail conditions.

  • Avenaster Fungal Nail Care Duo Set (day): apply once daily in the morning as a thin layer to the nail surface after cleaning and drying the area
  • For thick nails with Avenaster, gently file the nail surface every 2–3 days if needed

Always follow the instructions on your specific product and your healthcare provider's guidance — do not adjust frequency on your own.

🤒Side effects — in detail▾

Urea topical products are generally well tolerated, but some people notice mild reactions when they first start using them:

  • Temporary stinging at the application site
  • Burning sensation
  • Itching
  • Skin irritation

These effects are usually short-lived and go away once you stop using the product. If your skin becomes significantly more irritated, a rash appears anywhere on your body, or your condition gets worse, stop using the product and contact your healthcare provider.

⚠️Warnings & precautions▾
  • For external use only — never swallow urea products. If swallowed, call Poison Control or seek emergency care immediately.
  • Keep away from eyes, lips, and all mucous membranes (inside the mouth, nose). If contact occurs with the eyes, rinse thoroughly and seek medical advice.
  • Keep all urea products out of reach of children.
  • Stop use and call your provider if your skin condition worsens or a rash develops.
  • Pregnant women should use only if clearly needed — animal reproduction studies have not been conducted, and it is unknown if this product can harm a developing baby.
  • Use with caution while breastfeeding — it is not known if this product passes into breast milk.
  • Use only for the condition your provider has prescribed or recommended it for.
🔀What it interacts with▾

The FDA labels for urea topical products do not identify specific drug, food, or supplement interactions.

    This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

    📋Before taking it▾
    • Do not use if you have a known allergy to any ingredient in the urea product you are considering
    • Tell your doctor if you are pregnant — use only if your provider determines the benefit clearly outweighs any potential risk
    • Tell your doctor if you are breastfeeding — caution is advised since it is not known whether urea passes into breast milk
    • Keep these products away from children at all times
    • Do not apply to eyes, lips, or mucous membranes
    • Use only for the specific condition your provider directed you to treat
    🚑If you take too much▾

    If a urea topical product is swallowed, get medical help or contact a Poison Control Center right away. Do not wait for symptoms to appear.

    📡Pharmacodynamics — effects in the body▾

    Urea dissolves the intracellular matrix — the binding material between dead skin cells — causing the outer horny layer of the skin to loosen and shed. This leads to gradual softening of thickened or rough skin and nails. The result is smoother, more supple skin texture over regular use.

    📦How to store it▾

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Protect from freezing and excessive heat.

    📄 Written from Urea’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

    🩺 Pharmacist Counseling Corner

    Quick, plain-English answers to the questions patients ask most about Urea — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly does urea cream do for my skin? ▾
    Urea works by breaking down the bonds that hold tough, dead skin cells together, which lets that outer layer loosen and shed more normally. The end result is softer, smoother skin — especially in areas that are dry, rough, or thickened. It can do the same thing for thickened or damaged nails. Think of it as a kind of gentle 'dissolving' action on that hardened outer layer.
    How often should I apply urea cream, and do I need to rub it all the way in? ▾
    For most urea creams — including brands like Evara, Dermacure, and Uracin 20% — you'd apply it to the affected area twice a day and rub it in fully until it's absorbed. If you're using it on damaged or ingrown nails, the same twice-daily routine usually applies. Avenaster Fungal Nail Care Duo Set (day) is different — you apply it just once in the morning after cleaning and drying the area. Always follow exactly what your prescriber or your specific product label says.
    Will it sting? What side effects should I expect? ▾
    A little stinging, burning, or itching when you first apply it is pretty common and usually fades quickly on its own. Most people find these reactions are mild and short-lived. If the irritation is significant, a rash shows up anywhere on your body, or your skin condition seems to be getting worse instead of better, stop using it and give your healthcare provider a call.
    Is it safe to use if I'm pregnant or breastfeeding? ▾
    The honest answer is that there isn't a lot of safety data for this specific situation. Animal studies haven't been done, and it's not known whether urea can affect an unborn baby or pass into breast milk. Your provider may still recommend it if the benefit clearly outweighs any potential risk — but definitely have that conversation with them before using it during pregnancy or while nursing.
    Can I use urea cream near my eyes or mouth? ▾
    No — keep it well away from your eyes, lips, and the inside of your mouth or nose. These products are strictly for external use on skin and nails. If you accidentally get some in your eye, rinse it out thoroughly. And if any is swallowed — especially by a child — call Poison Control or seek emergency care right away.
    Can I use urea cream on my nails, not just my skin? ▾
    Yes — several urea products are specifically designed for use on damaged, ingrown, or thickened nails, not just skin. Most of the creams are applied twice daily directly to the affected nail. Avenaster Fungal Nail Care Duo Set (day) is a topical solution applied once daily to the nail surface and is specifically intended to soften thickened toenails and improve brittle nails related to a fungal condition called tinea pedis. Your specific product and your provider's instructions will tell you the best approach for your situation.
    Is Urea available over the counter? ▾
    Both — Urea is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
    When was Urea first available? ▾
    Urea has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Urea? ▾
    Urea is supplied by 36 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, SSG Ventures Inc, Laser Pharmaceuticals, LLC.

    💬 Answers drafted from Urea’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

    🧰 Keep exploring

    🌿Drug & Supplement CheckerUrea vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Urea NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

    💊 How Urea comes

    Urea is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

    Topical cream, ointment or gel

    On the skin
    Brands Dermacure Evara MILKBODyLotion Uracin 20%
    How this form is used
    What it may be used for
    • Evara and Dermacure creams are used to treat thickened skin conditions including dry skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, corns, calluses, and damaged or ingrown nails
    • Uracin 20% cream is used to debride and promote healing of hyperkeratotic skin lesions and to treat dry rough skin, dermatitis, psoriasis, eczema, and damaged nails
    • Urea 20 gel soothes, softens, and moisturizes dry, rough skin
    • MILKBODyLotion is applied to moisturize and hydrate the skin
    Important instructions
    • Evara: apply to affected skin twice daily and rub in until completely absorbed; apply to diseased or damaged nails twice daily or as directed by your physician
    • Dermacure: apply to affected skin twice daily and rub in until completely absorbed; apply to diseased or damaged nails twice daily or as directed by your physician
    • Uracin 20%: apply to affected area twice daily or as directed by a licensed healthcare practitioner, rubbing in until fully absorbed
    • MILKBODyLotion: apply evenly and carefully to the skin to ensure uniform hydration
    Available strengths 20 strengths
    41 mg/g 100 mg/mL 0.2 g/g 200 mg/g 390 mg/g 395 mg/g
    Show 14 more strengths Show fewer strengths
    400 mg/g 405 mg/g 410 mg/g 450 mg/g 450 mg/mL 470 mg/g 4 g/10 mL 12 g/12 g 20 g/100 mL 39 g/100 g 40 g/40 g 40 g/100 g 40 g/113 g 50 g/100 mL
    101 FDA-listed product records ⓘ

    Inhaler

    On the skin
    Brands Umecta Mousse
    How this form is used
    What it may be used for
    • Umecta Mousse is used to debride (remove dead tissue from) and promote healing of thickened skin lesions
    • Umecta Mousse treats conditions such as dry rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, calluses, and damaged or ingrown nails
    Important instructions
    • Umecta Mousse is applied topically to affected skin or nails
    • Follow your healthcare provider's directions for frequency and duration of use
    Available strengths 2 strengths
    400 mg/g 35 g/100 g
    3 FDA-listed product records ⓘ

    Topical solution

    On the skin
    Brands Avenaster Fungal Nail Care Duo Set (day)
    How this form is used
    What it may be used for
    • Avenaster Fungal Nail Care Duo Set (day) softens thickened keratin and dissolves dead cuticles
    • Avenaster Fungal Nail Care Duo Set (day) helps improve thickened toenails, brittle nails, and dry or peeling skin around nails associated with tinea pedis (athlete's foot)
    Important instructions
    • Avenaster Fungal Nail Care Duo Set (day): clean and dry the affected area with soap and water before applying
    • Avenaster Fungal Nail Care Duo Set (day): apply a thin layer of the Day Formula evenly to the nail surface once daily after waking, and allow it to absorb fully
    • Avenaster Fungal Nail Care Duo Set (day): for thick nails, gently file the surface every 2–3 days if needed — do not over-file or apply excessive pressure
    Available strengths 1 strength
    20 g/100 mL
    2 FDA-listed product records ⓘ

    Oral solution

    By mouth
    Available strengths 1 strength
    1 g/g
    1 FDA-listed product record ⓘ

    Other oral form

    By mouth
    Available strengths 1 strength
    1 g/g
    1 FDA-listed product record ⓘ

    Tablet

    By mouth
    Available strengths 1 strength
    21.6 mg
    1 FDA-listed product record ⓘ

    📊 Urea across the U.S. market

    How Urea appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

    6
    Dose forms ⓘ
    36
    Manufacturers
    34
    Brand names
    115
    FDA-listed product records ⓘ
    1996
    First marketed ⓘ

    FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

    Bryant Ranch Prepack17%
    SSG Ventures Inc8%
    Laser Pharmaceuticals, LLC5%
    Trinity Pharmaceuticals, LLC4%
    AvPAK4%
    BioComp Pharma, Inc.4%
    Other makers57%

    Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    📈 How widely Urea is used

    A general measure of how commonly Urea is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

    Think of this as a proxy for how widely Urea is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

    6,045
    Medicaid prescriptions filled (Q1–Q4 2025)
    $3.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Urea prescribed? Of the 1,596 medications we measure, Urea ranks #1,015 by Medicaid prescriptions — more than 36% of them.

    Where Urea ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #1,015 of 1,596
    #1,010 Pertuzumab, Trastuzuma... 6,412 Rx #1,011 Riociguat 6,299 Rx #1,012 Voriconazole 6,277 Rx #1,013 Amoxicillin / Omeprazo... 6,073 Rx #1,014 Sapropterin 6,060 Rx #1,015 Urea 6,045 Rx #1,016 Abaloparatide Injectio... 6,041 Rx #1,017 Tobramycin Injection 6,028 Rx #1,018 Zolmitriptan Nasal Spr... 5,993 Rx #1,019 Meperidine Injection 5,961 Rx #1,020 Calcitonin Salmon Nasa... 5,954 Rx

    Utilization by Urea product

    Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

    The 400 mg/mL topical cream is the most-dispensed Urea product — about 64% of these Medicaid prescriptions.

    urea 400 MG/ML Topical Cream Most dispensed

    3,859 Medicaid prescriptions (Q1–Q4 2025) 64% of Urea prescriptions shown $290,247 gross reimbursement (before rebates) ≈ $75 per prescription (gross)

    Summed across the 8 of 60 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198342

    urea 395 MG/ML Topical Cream

    1,360 Medicaid prescriptions (Q1–Q4 2025) 22% of Urea prescriptions shown $592,792 gross reimbursement (before rebates) ≈ $436 per prescription (gross)

    Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2627282

    urea 410 MG/ML Topical Cream

    781 Medicaid prescriptions (Q1–Q4 2025) 13% of Urea prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $3,083 per prescription (gross)

    Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1436933

    urea 200 MG/ML Topical Cream

    25 Medicaid prescriptions (Q1–Q4 2025) <1% of Urea prescriptions shown $358 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

    Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198886

    urea 390 MG/ML Topical Cream

    20 Medicaid prescriptions (Q1–Q4 2025) <1% of Urea prescriptions shown $5,082 gross reimbursement (before rebates) ≈ $254 per prescription (gross)

    Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1093289

    Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

    Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Urea, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 13 of 89 listed Urea NDCs with Medicaid activity.

    🔍 Compare Urea products

    A representative set of FDA-listed product records for Urea — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

    Showing 115 of 115 products — FDA National Drug Code Directory. See every product, package size and price: browse all 115 Urea NDCs →

    RxNorm Concept Web — From Ingredient to Every Form and Strength

    This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

    Ingredient (IN) Urea RxCUI 11002 8 dose forms · 38 strengths
    1. Dose form (SCDF) Medicated Shampoo RxCUI 377520 In current FDA listings
      Clinical drug / strength (SCD) 100 MG/ML RxCUI 260006
    2. Dose form (SCDF) Paste RxCUI 374436 In current FDA listings
      Clinical drug / strength (SCD) 0.5 MG/MG RxCUI 199072
    3. Dose form (SCDF) Topical Cream RxCUI 498906 In current FDA listings
      Clinical drug / strength (SCD) 50 MG/ML RxCUI 417434 100 MG/ML RxCUI 106199 200 MG/ML RxCUI 198886 220 MG/ML RxCUI 313554 300 MG/ML RxCUI 199090 350 MG/ML RxCUI 2046639 375 MG/ML RxCUI 1796546 390 MG/ML RxCUI 1093289 395 MG/ML RxCUI 2627282 400 MG/ML RxCUI 198342 405 MG/ML RxCUI 2741686 410 MG/ML RxCUI 1436933 420 MG/ML RxCUI 1490477 425 MG/ML RxCUI 1995088 450 MG/ML RxCUI 835837 470 MG/ML RxCUI 1494097 500 MG/ML RxCUI 416916
    4. Dose form (SCDF) Topical Foam RxCUI 584419 In current FDA listings
      Clinical drug / strength (SCD) 200 MG/ML RxCUI 584420 350 MG/ML RxCUI 849646 400 MG/ML RxCUI 700903
    5. Dose form (SCDF) Topical Gel RxCUI 377953 In current FDA listings
      Clinical drug / strength (SCD) 0.4 MG/MG RxCUI 349352 0.45 MG/MG RxCUI 827406 0.47 MG/MG RxCUI 1490479 0.5 MG/MG RxCUI 477225
    6. Dose form (SCDF) Topical Lotion RxCUI 377840 In current FDA listings
      Clinical drug / strength (SCD) 50 MG/ML RxCUI 204946 100 MG/ML RxCUI 198884 250 MG/ML RxCUI 199902 350 MG/ML RxCUI 477126 400 MG/ML RxCUI 351155 450 MG/ML RxCUI 866107 500 MG/ML RxCUI 707348
    7. Dose form (SCDF) Topical Ointment RxCUI 374592 In current FDA listings
      Clinical drug / strength (SCD) 0.1 MG/MG RxCUI 198885 0.2 MG/MG RxCUI 198887 0.5 MG/MG RxCUI 247760
    8. Dose form (SCDF) Topical Solution RxCUI 374480 In current FDA listings
      Clinical drug / strength (SCD) 200 MG/ML RxCUI 2743368 500 MG/ML RxCUI 616535

    Look up RxCUI 11002 in the RxCUI Atlas →

    RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

    🏷️ Sold under these brand names

    Aluvea CEM-Urea Utopic Kera-42 Kera Nail Keralac Rea-Lo Epimide 50 Carmol Gormel Ureacin-20 Aqua Care Gormel 10 Nutraplus Ureacin-10 Ultra Mide

    🏭 Manufacturers & labelers

    Bryant Ranch Prepack 19 SSG Ventures Inc 9 Laser Pharmaceuticals, LLC 6 Trinity Pharmaceuticals, LLC 5 AvPAK 5 BioComp Pharma, Inc. 5 Blue Heron Pharmaceuticals, LLC 5 Method Pharmaceuticals, LLC 5 Oncora Pharma, LLC 4 Odan Laboratories Ltd 4 Merck KGaA 4 Exact-Rx, Inc. 4 Akron Pharma Inc 3 PureTek Corporation 3 Akron Pharma Inc. 3 Bantry Pharma, LLC 3 Acella Pharmaceuticals 2 AvKARE 2 Canton Laboratories 2 Major Pharmaceuticals 2 Cintex Services, LLC 2 Krewe Pharma, LLC 2 Jiangxi Yudexi Pharmaceutical Co., LTD 2 Gabar Health Sciences Corp. 2

    …and 12 more on the FDA NDC directory.

    RxNorm drug class

    Urea belongs to the Helicobacter pylori Diagnostic class.

    Pharmacologic class Helicobacter pylori Diagnostic
    Drug family (ATC) Solutions producing osmotic diuresis, Carbamide products, Other diagnostic agents

    Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

    🔬 Where this comes from

    Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

    📄
    FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 3, 2025
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Urea.
    📈
    Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
    🚨
    Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
    🧾 Clinical label set — FDA-filed SPL labels retained for Urea after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    42
    NDC products indexed
    115
    Distinct labelers/manufacturers represented
    36
    Linked representative label ⓘ
    Shengnan (Guangzhou) Cosmetics Co., LTD
    Linked label effective
    Jan 3, 2025
    Composite sections available
    17
    Linked SPL Set ID
    2ac99028-a811-9332-e063-6294a90aee5c
    Linked SPL Document ID
    2ac99028-a812-9332-e063-6294a90aee5c
    Open the linked representative label on DailyMed ↗
    NDC package records associated with this linked SPL 1

    How we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 42 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

    For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Shengnan (Guangzhou) Cosmetics Co., LTD is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

    This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.