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MebendamaX Pinworm Pyrantel Pamoate 180 mg Tablet, 10-count — NDC 55758-441-10 (Billing 55758-0441-10)

by Pharmadel LLC · 10 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 10 tablets of MebendamaX Pinworm Pyrantel Pamoate 180 mg Tablet from Pharmadel LLC, marketed since Aug 2024 and currently FDA-listed. It is this product's only package size.

NDC 55758-0441-10
🏷️ FDA NDC (as labeled) 55758-441-10 billing pads the product segment with a zero
OTC 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 55758-441-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55758 labeler · 441 product · 10 package
Package marketed since
Aug 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5575844110 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55758-441-10
Product NDC 55758-441
11-digit billing NDC 55758044110
RxCUI 199107
UNII 81BK194Z5M
Application # M024
SPL Set ID 1d75b912-3550-7d4c-e063-6294a90ad5fa
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-01
Route ORAL
Dosage form TABLET
Substance PYRANTEL PAMOATE
Quick answers
  • RxCUI (RxNorm): 199107
Why two NDCs? The FDA registers this code as 55758-441-10 — 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 → 55758-0441-10. 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 Tetrahydropyrimidine derivatives class.

Drug family (ATC) Tetrahydropyrimidine derivatives
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

📗 Our plain-language guide HelloPharmacist
  • Pyrantel treats pinworm infections. Pinworms are small parasites that live in the intestines and are especially common in school-age children. If you or your child has been diagnos...
  • Nope — you can take it any time of day, with or without food. Tablets may be taken with milk or fruit juice if that helps. If you're using the liquid suspension, give the bottle a...
  • How do I take it — do I need to take it with food?
  • Yes, in most cases. Pinworms spread easily within a household, so the guidance is to treat everyone in the home at the same time — unless your doctor advises otherwise. This helps...
📖 Read our full Pyrantel guide →
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 eachPer 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.
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
55758-0441-10 You're viewing this Main listing 10 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2024-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
MebendamaX Pinworm 180 mgthis 55758-0441-10 Pharmadel 10 tablets — — FDA listed —
Pyrantel Pamoate 180 mg 58988-1760-01 ProMex 20 tablets — — FDA listed —
Vrmx 500 180 mg 69729-0141-10 OPMX 10 tablets — — FDA listed —
Lombrix 180 mg 69729-0807-10 OPMX 10 tablets — — 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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerPharmadel LLC
FDA applicationM024 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio67 products on file

More NDCs from Pharmadel LLC labeler code 55758

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Use For the treatment of pinworms.

⏱️ Dosage and Administration ~1 min read ▾

Directions READ THE PACKAGE CAREFULLY BEFORE TAKING THIS MEDICATION. take only according to directions do not exceed the recommended dosage, unless directed by a doctor medication should only be taken one time as a single dose; do not repeat treatment when one individual in a household has pinworms, the entire household should be treated unless otherwise advised adults, children 12 years of age and over, and children 2 years to under 12 years of age: this product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. use of a laxative is not necessary before, during, or after medication oral dosage is a single dose of 5 mg of pyrantel base per pound or 11 mg of pyrantel base per kilogram of body weight not to exceed 1 gram (1000mg) children under 25 lbs. or 2yrs old: do not use unless directed by a doctor Weight Dosage (taken as a single (1) dose as per weight) Less than 25 lb. or under 2 yrs. old do not use unless directed by a doctor 25-37 lbs.

2 tablets (125 mg) 38-62 lbs. 4 tablets (250 mg) 63-87 lbs. 6 tablets (375 mg) 88-112 lbs.

8 tablets (500 mg) 113-137 lbs. 10 tablets (625 mg) 138-162 lbs. 12 tablets (750 mg) 163-187 lbs.

14 tablets (875 mg) 188 lbs. and over 16 tablets (1,000 mg)

⚠️ Warnings 82 words ▾

Warnings Ask a doctor before use if you have liver disease are pregnant Stop use and ask a doctor if any symptoms or pinworms are still present after treatment any worms other than pinworms are present before or after treatment any of these symptoms that sometimes occur after taking the product persist: abdominal cramps nausea vomiting diarrhea headache dizziness Keep out of reach of children. In case of an accidental overdose get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 21 words ▾

Active ingredient & Purpose Active ingredient (in each tablet) Purpose Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... Pinworm treatment

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone k-30, silicon dioxide, talc

🎯 Purpose 17 words ▾

Active ingredient (in each tablet) Purpose Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... Pinworm treatment

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before use if you have liver disease are pregnant

📄 Stop Use and Ask a Doctor If 46 words ▾

Stop use and ask a doctor if any symptoms or pinworms are still present after treatment any worms other than pinworms are present before or after treatment any of these symptoms that sometimes occur after taking the product persist: abdominal cramps nausea vomiting diarrhea headache dizziness

📄 Keep Out of Reach of Children 23 words ▾

Keep out of reach of children. In case of an accidental overdose get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel PDP mebendamax

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

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 MebendamaX Pinworm (this brand).

Top reported reactions

Adverse Event17
Enterobiasis4
Headache3
Treatment Failure3
Helminthic Infection2
Accident At Work1
Accidental Overdose1

Age at onset

Child1
Adolescent1
Adult4

Reporter sex

42 reports
Male · 33%
Female · 57%
Unknown · 10%

Serious outcomes

Death3
Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 24 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

Over-the-counter (OTC) product
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 "Otc Monograph Drug". 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 Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 55758-0440-03 · Pharmadel 55758-0442-15 · Pharmadel →
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.