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Xyralid Hemorrhoidal Hemorrhoidal Suppositories 88.5 g/100g; .26 g/100g Suppository — NDC 57483-0410-13 package photo

Xyralid Hemorrhoidal Hemorrhoidal Suppositories 88.5 g/100g; .26 g/100g Suppository

by Innovus Pharmaceuticals, Inc. · 4 BLISTER PACK in 1 CARTON (57483-410-13) / 24 g in 1 BLISTER PACK (57483-410-12)
NDC 57483-0410-13
🏷️ FDA NDC (as labeled) 57483-410-13 billing pads the product segment with a zero
OTC 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) 57483-410-13
Product NDC 57483-410
11-digit billing NDC 57483041013
RxCUI 1438497
UNII 512OYT1CRR, 04JA59TNSJ
Application # part346
SPL Set ID 8a885822-42e7-44e0-82d6-fa967123866e
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-25
Route RECTAL
Dosage form SUPPOSITORY
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 57483-410-13 — 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 → 57483-0410-13. 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.

🏭 Manufacturer & labeler

LabelerInnovus Pharmaceuticals, Inc.
FDA applicationpart346 (OTC MONOGRAPH FINAL)
Labeler code57483
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio20 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

🧪 What is this product?

Xyralid is an over-the-counter rectal suppository marketed under FDA's OTC monograph rules for hemorrhoidal products. It contains phenylephrine hydrochloride, a decongestant that typically works by narrowing blood vessels in the rectal area, and cocoa butter, a base ingredient commonly used in suppositories for lubrication and ease of insertion. This product is typically used to help relieve symptoms associated with hemorrhoids, such as itching and discomfort.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color white
ShapeBullet
Size32 mm
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.

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

  • 0.02 g / 100 g UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 11.2 g / 100 g UNII 461P5CJN6T
    Modified corn starch derived from cornstarch and treated with octenyl succinic anhydride. It acts as a thickener, stabilizer, and emulsifier to improve texture and prevent separation in the medicine.
  • 0.02 g / 100 g UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.

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

The official label also statescorn starch, methylparaben, propylparaben

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Hemorrhoidal 2211 mg/1; 6.5 mg 00113-0279-53 L. 12 suppositories $0.297 — Availability likely —
rugby hemorrhoidal 2211 mg/1; 6.5 mg 00536-1186-12 Rugby 12 suppositories $0.297 — Availability likely —
Hemorrhoidal 2.39 g/1; 6.75 mg 46122-0777-65 Amerisourcebergen 12 suppositories $0.297 — Availability likely —
Leader Hemorrhoidal 2211 mg/1; 6.5 mg 70000-0223-01 Cardinal 12 suppositories $0.297 — Availability likely —
foster and thrive hemorrhoidal 2211 mg/1; 6.5 mg 70677-1292-01 Strategic 12 suppositories $0.297 — Availability likely —
Walgreens Hemorrhoidal 2211 mg/1; 6.25 mg 00363-0476-24 Walgreens 24 suppositories — — FDA listed —
Preparation H 00573-2884-12 Haleon 12 suppositories — — FDA listed —
hemorrhoidal relief 2211 mg/1; 6.5 mg 11822-0005-01 Rite 12 suppositories — — FDA listed —
Hemorrhoidal cocoa butter 2.5 mg/g; 884.4 mg/g 13709-0323-01 NeilMed 24 capsules — — FDA listed —
Signature Care Hemorrhoidal 2211 mg/1; 6.5 mg 21130-0628-53 Safeway 12 suppositories — — Discontinued —
hemorrhoidal 2211 mg/1; 6.5 mg 30142-0279-62 Kroger 24 suppositories — — FDA listed —
topcare hemorrhoidal 2211 mg/1; 6.5 mg 36800-0279-53 Topco 12 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 37808-0279-62 H 24 suppositories — — FDA listed —
Equaline Hemorrhoidal 2211 mg/1; 6.5 mg 41163-0279-53 United 12 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 41250-0279-62 Meijer 24 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 42507-0279-53 HyVee 12 suppositories — — FDA listed —
equate hemorrhoidal 2211 mg/1; 6.5 mg 49035-0463-62 Wal-Mart 24 suppositories — — FDA listed —
Exchange Select Hemorrhoidal 2211 mg/1; 6.5 mg 55301-0279-62 Army 24 suppositories — — FDA listed —
rexall hemorrhoidal 2211 mg/1; 6.5 mg 55910-0279-53 Dolgencorp 12 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 56062-0279-53 Publix 12 suppositories — — FDA listed —
Xyralid Hemorrhoidal 88.5 g/100g; .26 g/100gthis 57483-0410-13 Innovus 24 g — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 59779-0279-53 CVS 12 suppositories — — FDA listed —
Hemorrhoidal 1768.8 mg/1; 5 mg 70795-1021-02 GRAXCELL 12 suppositories — — FDA listed —
basic care hemorrhoidal 2211 mg/1; 6.5 mg 72288-0800-62 Amazon.com 24 suppositories — — 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.

🔬 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 Xyralid Hemorrhoidal (this brand).

Top reported reactions

Arthralgia1
Cervical Radiculopathy1
Diabetes Mellitus1
Dyssomnia1
Gastritis1
Gastrointestinal Inflammation1
Headache1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
57483-0410-13 You're viewing this 4 BLISTER PACK in 1 CARTON (57483-410-13) / 24 g in 1 BLISTER PACK (57483-410-12) 2018-03-25 Active

🧭 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 ✓ 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 "Otc Monograph Final". 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 57483-410-13, 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: 57483-0410-13, written without dashes as 57483041013. 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 57483-0410-13, the first segment (57483) is the labeler code FDA assigned to Innovus Pharmaceuticals, Inc.; the middle segment (0410) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (13) 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 Innovus Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Innovus Pharmaceuticals, 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 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.

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

When using this product do not exceed the recommended daily dosage unless directed by a doctor

⏱️ Dosage and Administration 70 words ▾

Directions -Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a toilet tissue or a soft cloth. -remove the wrapper before inserting into the rectum. -insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. -Children under 12 years of age: consult a doctor

⚠️ Warnings 5 words ▾

Warnings For rectal use only

📦 Storage and Handling 10 words ▾

Other information Store at 20-25 o C (68-77 o F)

🧪 Active Ingredient 11 words ▾

Active ingredients Active Ingredients Purpose Cocoa butter 88.50%...................................................................Protectant Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients corn starch, methylparaben, propylparaben

🎯 Purpose 23 words ▾

Uses temporarily shrinks hemorrhoidal tissue temporarily relieves itching, burning, and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas

Purpose Protectant Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 57483-0280-02 · Innovus 57483-0530-31 · Innovus →
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.