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Urea Cream 40% 400 mg/g Cream, 1 bottle — NDC 16477-0340-01 package photo

Urea Cream 40% 400 mg/g Cream, 1 bottle

by Laser Pharmaceuticals, LLC · 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTIC
NDC 16477-0340-01
🏷️ FDA NDC (as labeled) 16477-340-01 billing pads the product segment with a zero
This package
Contains1 bottle Pack sizes3 compare ↓
Also comes in: 85 g 16477-0340-03 198.4 g 16477-0340-07
Rx only On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 16477-340-01
Product NDC 16477-340
11-digit billing NDC 16477034001
NCPDP billing unit GM — per gram (weight)
RxCUI 198342
UNII 8W8T17847W
SPL Set ID ef2db58d-e760-417d-8574-45a411c49b47
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-04
Route TOPICAL
Dosage form CREAM
Substance UREA
GPI-14 90660080003725
GPI class Urea
GCN Seq No 016308
GCN 24774
HICL code 002716
Ingredient (HICL) Urea
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 24:36.12.00
AHFS class Osmotic Diuretics (24:36)
FDB label name UREA 40% CREAM
FDB brand name Urea
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 16477-340-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 16477-0340-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Helicobacter pylori Diagnostic class.

Pharmacologic class Helicobacter pylori Diagnostic
Drug family (ATC) Solutions producing osmotic diuresis, Carbamide products, Other diagnostic agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLaser Pharmaceuticals, LLC
Labeler code16477
First marketedMay 2018
Product typeHuman Prescription Drug
Portfolio9 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name UREA 40% CREAM Ingredient Urea
📗 Our plain-language guide HelloPharmacist
  • 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...
  • What exactly does urea cream do for my skin?
  • 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 u...
  • How often should I apply urea cream, and do I need to rub it all the way in?
📖 Read our full Urea guide →
7
Nutrient depletion considerations

Urea may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Urea nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 8FA93U5T67
    A waxy substance made from plant oils that acts as an emulsifier and thickener. It helps mix oil and water components in the medicine and gives the product a smooth texture.
  • UNII 2RJS3559D3
    A waxy emulsifier derived from plant or petroleum sources. It helps blend oil and water ingredients together and improves how the medicine spreads or absorbs through the skin.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 85 g 198.4 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Urea 40% 400 mg/g 39328-0019-01 Patrin 1 bottle $1.037 — Availability likely —
Urea 40 g/100g 50268-0872-28 AvPAK 28.35 g $1.037 — Availability likely —
Urea Cream 40 Percent 400 mg/g 58657-0489-01 Method 28.35 g $1.037 — Availability likely —
Urea 40 Percent 400 mg/g 58657-0487-01 Method 28.35 g $1.382 — FDA listed —
Urea Cream 40% 400 mg/gthis 16477-0340-01 Laser 1 bottle — — FDA listed —
Urea 400 mg/g 24470-0939-01 Cintex 1 bottle — — FDA listed —
Urea 400 mg/g 44523-0617-01 BioComp 1 bottle — — FDA listed —
Urea 40 Percent 400 mg/g 63629-9267-01 Bryant 198.4 g — — FDA listed —
Urea Cream 40 Percent 400 mg/g 71335-2868-01 Bryant 28.35 g — — FDA listed —
Urea 40 Percent 400 mg/g 71335-2890-01 Bryant 198.4 g — — FDA listed —
Urea Cream 40% 400 mg/g 71399-8456-01 Akron 28.35 g — — FDA listed —
Urea 40 Percent 400 mg/g 72162-1668-02 Bryant 198.4 g — — FDA listed —
Urea Cream 40 Percent 400 mg/g 72162-2203-04 Bryant 85 g — — FDA listed —
Urevia Plus 400 mg/g 85622-0603-04 Blue 1 jar — — FDA listed —
Urea 40 400 mg/g 87021-0603-04 Krewe 1 jar — — FDA listed —
Urea 400 mg/g 24470-0962-08 Cintex 226.8 g — — FDA listed —
Urea 400 mg/g 81542-0201-08 Bantry 226.8 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Urea (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Urea. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.1K
Claims incl. refills
98
Beneficiaries
88
Spend / beneficiary
$12.87
Spend / claim
$11.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Urea — the ingredient across all brands.

Top reported reactions

Diarrhoea191
Fatigue182
Nausea158
Decreased Appetite111
Rash105
Dyspnoea103
Vomiting103

Reporter sex

2,168 reports

Serious outcomes

Death211
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 273 84
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
16477-0340-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTIC 2018-05-04 Active
16477-0340-03 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-03) / 85 g in 1 BOTTLE, PLASTIC 2018-05-04 Active
16477-0340-07 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-07) / 198.4 g in 1 BOTTLE, PLASTIC 2018-05-04 Active

Pack size FAQ

What quantity is in NDC 16477-0340-01?
NDC 16477-0340-01 contains 1 bottle — 1 bottle, plastic in 1 carton / 28.35 g in 1 bottle, plastic.
What is the difference between NDC 16477-0340-01 and NDC 16477-0340-07?
Both are Urea Cream 40% 400 mg/g Cream — the drug itself is identical. NDC 16477-0340-01 is the 1 bottle package, while NDC 16477-0340-07 is the 1 bottle package.
What NDC number is used to bill for this package of Urea Cream 40% 400 mg/g Cream?
Bill NDC 16477-0340-01 — the 11-digit billing format is 16477034001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 16477-340-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 16477-0340-01, written without dashes as 16477034001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 16477-0340-01, the first segment (16477) is the labeler code FDA assigned to Laser Pharmaceuticals, LLC; the middle segment (0340) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Laser Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (16477-0340-03), 1 bottle (16477-0340-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Laser Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 65 words ▾

Indications and Usage For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

⏱️ Dosage and Administration 124 words ▾

Dosage and Administration Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency.

Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.

⛔ Contraindications 9 words ▾

Contraindications Known hypersensitivity to any of the listed ingredients.

⚠️ Warnings and Cautions 13 words ▾

Urea Cream 40% Rx Only For external use only. Not for ophthalmic use.

⚠️ Warnings 13 words ▾

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

🤒 Adverse Reactions 17 words ▾

Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

🤰 Pregnancy 51 words ▾

PREGNANACY Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.

🧬 Clinical Pharmacology 34 words ▾

Clinical Pharmacology Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

📦 How Supplied / Storage and Handling 43 words ▾

How Supplied Urea 40% Cream 1 oz.(28.35 g): NDC 16477-340-01; Urea 40% Cream 3 oz.(85 g): NDC 16477-340-03; Urea 40% Cream 7 oz.(198.4 g): NDC 16477-340-07 Store at room temperature 15°C - 30°C (59°F - 86°F). Protect from freezing. Keep bottle tightly closed.

📋 Description 66 words ▾

Description Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure: image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16477-0202-12 · Laser 16477-0341-08 · Laser →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.