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Leader Hemorrhoidal cocoa butter, phenylephrine HCl 2211 mg; 6.5 mg Suppository, 12 suppositories — NDC 70000-0223-01 package photo

Leader Hemorrhoidal cocoa butter, phenylephrine HCl 2211 mg; 6.5 mg Suppository, 12 suppositories

by Cardinal Health 110, LLC. dba Leader · 12 BLISTER PACK in 1 CARTON (70000-0223-1) / 1 SUPPOSITORY in 1 BLISTER PACK
NDC 70000-0223-01
🏷️ FDA NDC (as labeled) 70000-0223-1 billing pads the package 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) 70000-0223-1
Product NDC 70000-0223
11-digit billing NDC 70000022301
NCPDP billing unit EA — each (per item)
RxCUI 1438497
UNII 512OYT1CRR, 04JA59TNSJ
Application # M015
SPL Set ID c4814524-0f4c-4351-a431-5b4b6431fd28
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-01-17
Route RECTAL
Dosage form SUPPOSITORY
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
GPI-14 89994002335225
GPI class Hemorrhoidal
GCN Seq No 071662
GCN 35585
HICL code 040185
Ingredient (HICL) Phenylephrine Hcl/Cocoa Butter
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3D
Therapeutic class — specific (HIC3) Hemorrhoidal Preparations
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name HEMORRHOIDAL SUPPOSITORIES
FDB brand name Hemorrhoidal Suppositories
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0223-1 — a 5-4-1 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 package segment → 70000-0223-01. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health 110, LLC. dba Leader
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2017
Product typeHuman Otc Drug
Portfolio163 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 HEMORRHOIDAL SUPPOSITORIES Ingredient Phenylephrine Hcl/Cocoa Butter
🧪 What is this product?

Leader Hemorrhoidal is a rectal suppository containing cocoa butter and phenylephrine hydrochloride. This is an over-the-counter monograph product marketed under FDA rules for hemorrhoidal preparations. Cocoa butter functions as a lubricant and protectant in the rectal area. Phenylephrine hydrochloride is a decongestant that is typically used to reduce swelling and congestion associated with hemorrhoids.

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 Yellow
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.

  • 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.
  • 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.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statesmethylparaben, propylparaben, topical starch

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 eaPer package
Retail pharmacies payNADAC · weekly $0.297 $3.57 / 12 suppository
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.297 $0.170
▲ Up 45% over the last 24 months.
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 mgthis 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/100g 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0223-01 You're viewing this 12 BLISTER PACK in 1 CARTON (70000-0223-1) / 1 SUPPOSITORY in 1 BLISTER PACK 2017-01-17 Active

📄 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 45 words ▾

Uses • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

⏱️ Dosage and Administration 144 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 tissue or a soft cloth before insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: • hold suppository with rounded end up • see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down” • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository • remove exposed suppository from wrapper • 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: ask a doctor Other information • store at 20-25°C (68-77°F)

⚠️ Warnings 104 words ▾

Warnings For rectal use only Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days If pregnant or breast feeding, ask a health professional before use.

📦 Storage and Handling 7 words ▾

Other information • store at 20-25°C (68-77°F)

🧪 Active Ingredient 11 words ▾

Active ingredients (in each suppository) Cocoa butter 88.44% Phenylephrine HCl 0.25%

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients methylparaben, propylparaben, topical starch Questions or comments? 1-800-719-9260

🎯 Purpose 3 words ▾

Purposes Protectant Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0221-01 · Cardinal 70000-0225-01 · Cardinal →
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.