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Urea 400 mg/g Cream, 198.4 g — NDC 44523-0617-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Urea 400 mg/g Cream, 198.4 g — NDC 44523-617-07 (Billing 44523-0617-07)

by BioComp Pharma, Inc. · 198.4 g in 1 BOTTLE, PLASTIC

This is a package of 198.4 g of Urea 400 mg/g Cream from BioComp Pharma, Inc., marketed since Mar 2018 and currently FDA-listed.

NDC 44523-0617-07
🏷️ FDA NDC (as labeled) 44523-617-07 billing pads the product segment with a zero
This package
Contains198.4 g Medicaid pays$0.4551 / unit · 12 mo Per package$90.29 / 198.4 g · Medicaid Pack sizes3 compare ↓
Product page 44523-0617-03 Also comes in: 28.35 g 44523-617-01 85 g 44523-617-03
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 44523-617-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
44523 labeler · 617 product · 07 package
Package marketed since
Mar 15, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
198 g per package
Barcode (UPC)
0344523617070, 0344523617032
Medicaid fills, this package
545 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44523-617-07
Product NDC 44523-617
11-digit billing NDC 44523061707
NCPDP billing unit GM — per gram (weight)
RxCUI 198342
UNII 8W8T17847W
UPC 0344523617070, 0344523617032
SPL Set ID 6774a5ef-9bb0-4e7a-e053-2a91aa0af47f
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-15
Route TOPICAL
Dosage form CREAM
Substance UREA

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 016308
  • GCN: 24774
  • GPI-14 (Medi-Span): 90660080003725
  • HICL (First Databank): 002716
  • AHFS class code: 24:36.12.00
  • RxCUI (RxNorm): 198342
Why two NDCs? The FDA registers this code as 44523-617-07 — 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 → 44523-0617-07. 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.

Clinical

Label name UREA 40% CREAM Ingredient Urea
📗 Our plain-language guide HelloPharmacist
  • It softens thick, dry, scaly skin. Providers use it for conditions like psoriasis, eczema, ichthyosis, calluses, and damaged or ingrown nails. It can also help clear dead tissue fr...
  • Most urea creams on the label are applied twice a day, or as your prescriber directs. Rub it in until it is fully absorbed. Wash your hands first. Avenaster Fungal Nail Care Duo Se...
  • It can. Some people notice temporary stinging, burning, itching or irritation, which usually fades once you stop using it. If you get redness, a rash, or things get worse, stop and...
  • No. It is for external use only. Keep it away from your eyes, lips and the inside of your nose or mouth. If it is swallowed, call Poison Control or get medical help right away.
📖 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.

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 $0.4551 $90.29 / 198.4 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44523-0617-01 44523-617-01 1 BOTTLE, PLASTIC in 1 CARTON / 28.35 g in 1 BOTTLE, PLASTIC 2018-03-15 — Active
44523-0617-03 44523-617-03 Main listing 85 g in 1 BOTTLE, PLASTIC 2018-03-15 — Active
44523-0617-07 You're viewing this 198.4 g in 1 BOTTLE, PLASTIC 2018-03-15 — Active

This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 85 g pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 198.4 g — 198.4 g in 1 bottle, plastic.
How does this package differ from NDC 44523-0617-01?
Both are Urea 400 mg/g Cream — the drug itself is identical. This page's package is the 198.4 g one, while NDC 44523-0617-01 is the 1 bottle package.
What NDC number is used to bill for this package of Urea 400 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Urea 40% 400 mg/g 39328-0019-01 Patrin 1 bottle $1.049 — Availability likely —
Urea 40 g/100g 50268-0872-28 AvPAK 28.35 g $1.049 — Availability likely —
Urea Cream 40 Percent 400 mg/g 58657-0489-01 Method 28.35 g $1.049 — Availability likely —
Urea 40 Percent 400 mg/g 58657-0487-01 Method 28.35 g $1.382 — FDA listed —
Urea Cream 40% 400 mg/g 16477-0340-01 Laser 1 bottle — — FDA listed —
Urea 400 mg/g 24470-0939-01 Cintex 1 bottle — — FDA listed —
Urea 400 mg/gthis 44523-0617-07 BioComp 198.4 g — — 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
Mar 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Urea inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • 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 SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 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.

10 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.

Manufacturer & labeler

LabelerBioComp Pharma, Inc.
Labeler code44523
First marketedMar 2018
Product typeHuman Prescription Drug
Portfolio28 products on file

More NDCs from BioComp Pharma, Inc. labeler code 44523

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.

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 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

INDICATIONS: 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 eschar. 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 36 words ▾

DOSAGE AND ADMINISTRATION: Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

⚠️ Warnings 7 words ▾

WARNING: KEEP OUT OF REACH OF CHILDREN.

🤒 Adverse Reactions 20 words ▾

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

🧬 Clinical Pharmacology 44 words ▾

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin. Pharmacokinetics: The mechanism of action of topically applied urea is not yet known.

📦 How Supplied / Storage and Handling 36 words ▾

HOW SUPPLIED: 1 oz. (28.35 g) bottles, NDC 44523-617-01 3 oz. (85 g) bottles, NDC 44523-617-03 7 oz. (198.4 g) bottles, NDC 44523-617-07 To report a serious adverse event or obtain product information, call 1-866-762-2365. Image

📦 Storage and Handling 57 words ▾

STORAGE: 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). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.

📋 Description 45 words ▾

DESCRIPTION: Each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: structure.jpg

⚠️ Precautions 209 words ▾

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed.

If redness or irritation occurs, discontinue use and consult a physician. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C.

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

📄 Package Label / Principal Display Panel 4 words ▾

Label Label Label Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
545
Units reimbursed last 4 qtrs
106K
Gross reimbursed last 4 qtrs
$48.2K
Avg / prescription
$88.52
Avg / unit
$0.4551
Latest quarter Q1 2026
152Rx
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 234 Rx Managed care · 311 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 10,997 units · 192 per 100k residents MN Wisconsin: 29,987 units · 507 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 2,778 units · 37.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 16,864 units · 237 per 100k residents TN North Carolina: 12,084 units · 112 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 23,378 units · 511 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 7,539 units · 68.4 per 100k residents GA D.C.: 2,381 units · 351 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
37.4511
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 511 /100k
2 Wisconsin 507 /100k
3 D.C. 351 /100k
4 Tennessee 237 /100k
5 Minnesota 192 /100k
6 North Carolina 112 /100k
7 Georgia 68.4 /100k
8 Arizona 37.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
85 g44523-0617-03 1,200 Rx · $105,466
198.4 g this page44523-0617-07 545 Rx · $48,243
1 bottle44523-0617-01 450 Rx · $35,459
Drug total (last 4 qtrs): 2,195 Rx · 238,794 units · $189,168 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Urea — 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

Age at onset

Infant1
Child8
Adolescent2
Adult273
Elderly298

Reporter sex

2,168 reports
Male · 50%
Female · 50%

Serious outcomes

Death212
Life-threatening109
Disabling52
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 273 0
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.

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) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 BioComp Pharma, Inc.. 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 (44523-0617-01), 85 g (44523-0617-03). 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?
BioComp Pharma, Inc. 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.
← 44523-0613-06 · BioComp 44523-0618-03 · BioComp →
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.