Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE 1768.8 mg; 5 mg Suppository, 24 suppositories
by GRAXCELL PHARMACEUTICAL, LLC · 24 BLISTER PACK in 1 BOX (70795-1021-4) / 1 SUPPOSITORY in 1 BLISTER PACK
NDC 70795-1021-04
🏷️ FDA NDC (as labeled)
70795-1021-4
billing pads the package segment with a zero
This package
Contains24 suppositories
Pack sizes2 compare ↓
Also comes in:
12 suppositories 70795-1021-02
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 →
🆔 Identity & classification
FDA NDC (as labeled)
70795-1021-4
Product NDC
70795-1021
11-digit billing NDC
70795102104
NCPDP billing unit
EA — each (per item)
RxCUI
1438497
UNII
512OYT1CRR, 04JA59TNSJ
Application #
M015
SPL Set ID
5162baee-0d63-494e-8046-459437b85348
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
2017-03-29
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 70795-1021-4 — 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 → 70795-1021-04. 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
LabelerGRAXCELL PHARMACEUTICAL, LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code70795
First marketedMar 2017
Product typeHuman Otc Drug
Portfolio4 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?
This is a rectal suppository containing cocoa butter and phenylephrine hydrochloride, marketed as an over-the-counter monograph product for hemorrhoid symptom relief. Phenylephrine hydrochloride is a decongestant that typically functions to reduce swelling and constriction in the affected area. Cocoa butter serves as a base and lubricant in the suppository formulation. This product is designed to be inserted rectally for local relief of hemorrhoid-related discomfort.
Patient education
Supplement & herbal interactions
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.
💬 Questions about COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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, 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 system | Per each | Per 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.
Try another pack size:
12 suppositories
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/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 mgthis 70795-1021-04 | GRAXCELL | 24 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
Mar 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.
🔬 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
Age at onset
Reporter sex
Male · 44%
Female · 56%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70795-1021-02 | 12 BLISTER PACK in 1 BOX (70795-1021-2) / 1 SUPPOSITORY in 1 BLISTER PACK | 2017-03-29 | Active |
| 70795-1021-04 You're viewing this | 24 BLISTER PACK in 1 BOX (70795-1021-4) / 1 SUPPOSITORY in 1 BLISTER PACK | 2017-04-22 | Active |
Pack size FAQ
What quantity is in NDC 70795-1021-04?
NDC 70795-1021-04 contains 24 suppositories — 24 blister pack in 1 box / 1 suppository in 1 blister pack.
What is the difference between NDC 70795-1021-04 and NDC 70795-1021-02?
Both are Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE 1768.8 mg; 5 mg Suppository — the drug itself is identical. NDC 70795-1021-04 is the 24 suppositories package, while NDC 70795-1021-02 is the 12 suppositories package.
What NDC number is used to bill for this package of Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE 1768.8 mg; 5 mg Suppository?
Bill NDC 70795-1021-04 — the 11-digit billing format is 70795102104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 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 FDA registers it as 70795-1021-4, 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: 70795-1021-04, written without dashes as 70795102104. 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 70795-1021-04, the first segment (70795) is the labeler code FDA assigned to GRAXCELL PHARMACEUTICAL, LLC; the middle segment (1021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 GRAXCELL PHARMACEUTICAL, LLC. 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 1 other package presentation of this same product, including 12 suppositories (70795-1021-02). 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?
GRAXCELL PHARMACEUTICAL, 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.
📄 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 ▾
Uses temporarily shrinks hemorrhoidal tissues gives temporary relief to the itching, burning and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas
⏱️ Dosage and Administration ▾
Directions Adults detach one suppository from the strip. 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 doctor
⚠️ Warnings ▾
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 high blood pressure diabetes difficulty in urination due to enlargement of the prostate gland 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.
📦 Storage and Handling ▾
Other Information Store at room temperature or in a cool place but not over 80° F
🧪 Active Ingredient ▾
Active Ingredients (per suppository) Cocoa butter 88.44 % Phenylephrine hydrochloride 0.25 %
🧪 Inactive Ingredients ▾
Inactive ingredients methylparaben, propylparaben, starch
🎯 Purpose ▾
Purpose Protectant Vasoconstructor
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.