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Hemorrhoidal Cocoa Butter, Phenylephrine HCl 2.39 g; 6.75 mg Suppository, 12 suppositories — NDC 46122-0777-65 package photo

Hemorrhoidal Cocoa Butter, Phenylephrine HCl 2.39 g; 6.75 mg Suppository, 12 suppositories

by Amerisourcebergen Drug Corporation · 2 BLISTER PACK in 1 CARTON (46122-777-65) / 6 SUPPOSITORY in 1 BLISTER PACK
NDC 46122-0777-65
🏷️ FDA NDC (as labeled) 46122-777-65 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) 46122-777-65
Product NDC 46122-777
11-digit billing NDC 46122077765
NCPDP billing unit EA — each (per item)
UNII 512OYT1CRR, 04JA59TNSJ
UPC 0346122777650
Application # M015
SPL Set ID 231a850a-bad6-9a30-e063-6394a90a0fdc
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 2024-10-15
Route RECTAL
Dosage form SUPPOSITORY
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
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 GNP 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 46122-777-65 — 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 → 46122-0777-65. 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

LabelerAmerisourcebergen Drug Corporation
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code46122
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio37 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 GNP HEMORRHOIDAL SUPPOSITORIES Ingredient Phenylephrine Hcl/Cocoa Butter
🧪 What is this product?

This is an over-the-counter rectal suppository marketed under FDA's OTC monograph rules for hemorrhoidal products. It contains cocoa butter, which functions as a lubricant and emollient to soften stool and ease discomfort, and phenylephrine hydrochloride, a decongestant typically used to reduce swelling and shrink blood vessels in the rectal tissue. The suppository form is inserted into the rectum to deliver these ingredients locally to hemorrhoidal tissue.

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.

🧪 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 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 eaPer package
Retail pharmacies payNADAC · weekly $0.297 $3.57 / 12 suppositories
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 2025 Feb 2026 May 2026 Aug 2026 $0.297 $0.243
▲ Up 17% over the last 9 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 mgthis 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/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 —
Hemorrhoidal 2.39 g/1; 6.75 mg 69842-0785-48 CVS 48 suppositories — — FDA listed —
Hemorrhoidal 2.39 g/1; 6.75 mg 68016-0322-12 Pharmacy 12 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

🏛️
2024
On the market since
Oct 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.

🔬 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 Hemorrhoidal (this brand).

Top reported reactions

Pain11
Dyspnoea7
Nausea7
Fatigue6
Constipation5
Death5
Pneumonia5

Age at onset

Adult6
Elderly6

Reporter sex

73 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization17
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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
46122-0777-65 You're viewing this 2 BLISTER PACK in 1 CARTON (46122-777-65) / 6 SUPPOSITORY in 1 BLISTER PACK 2024-10-15 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Uses temporarily shrinks hemorrhoidal tissue gives temporary relief to the itching, burning and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas

⏱️ Dosage and Administration 129 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 soft cloth before insertion of this product. Detach one suppository from the strip; remove plastic wrapper before inserting into the rectum as follows: ​ hold suppository with rounded end up as shown, carefully separate plastic tabs by inserting tip of finger nail at end marked "peep here" slowly and evenly peel apart (do not tear) plastic by pulling tabs down both sides, to expose the suppository remove exposed suppository from wrapper insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowl movement children under 12 years of age ask a doctor

⚠️ Warnings 116 words ▾

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

🧪 Active Ingredient 10 words ▾

Active Ingredients (per suppository) Cocoa butter 88.44% Phenylephrine hydrochloride 0.25%

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients corn starch, methylparaben, propylparaben

🎯 Purpose 3 words ▾

Purpose Protectant Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 46122-0776-37 · Amerisourcebergen 46122-0778-34 · AmerisourceBergen →
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.