Equaline Hemorrhoidal cocoa butter, phenylephrine HCl 2211 mg; 6.5 mg Suppository, 12 suppositories
by United Natural Foods, Inc. dba UNFI · 12 BLISTER PACK in 1 CARTON (41163-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK
NDC 41163-0279-53
🏷️ FDA NDC (as labeled)
41163-279-53
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 →
🆔 Identity & classification
FDA NDC (as labeled)
41163-279-53
Product NDC
41163-279
11-digit billing NDC
41163027953
NCPDP billing unit
EA — each (per item)
RxCUI
1438497
UNII
512OYT1CRR, 04JA59TNSJ
Application #
M015
SPL Set ID
d29b7824-ff9e-4875-b3de-92721c8add0e
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
2014-09-05
Route
RECTAL
Dosage form
SUPPOSITORY
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
GPI-14
89994002335225
GPI class
EQL 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
EQL 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 41163-279-53 — 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 → 41163-0279-53. 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
LabelerUnited Natural Foods, Inc. dba UNFI
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code41163
First marketedSep 2014
Product typeHuman Otc Drug
Portfolio211 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 EQL HEMORRHOIDAL SUPPOSITORIES Ingredient Phenylephrine Hcl/Cocoa Butter
🧪 What is this product?
Equaline Hemorrhoidal is an over-the-counter rectal suppository marketed under FDA's OTC monograph rules for hemorrhoid products. It contains cocoa butter, which functions as an emollient and lubricant to soften stool and ease discomfort, and phenylephrine hydrochloride, a decongestant typically used to reduce swelling and shrink blood vessels in the affected area. This combination is commonly used to provide temporary relief of hemorrhoid symptoms such as itching, burning, and 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 HCl?
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.
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.
💲 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.
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 mgthis 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
🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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 Equaline Hemorrhoidal (this brand).
Top reported reactions
Reporter sex
Female · 100%
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 |
|---|---|---|---|
| 41163-0279-53 You're viewing this | 12 BLISTER PACK in 1 CARTON (41163-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK | 2014-09-05 | 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 | — 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 FDA registers it as 41163-279-53, 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: 41163-0279-53, written without dashes as 41163027953. 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 41163-0279-53, the first segment (41163) is the labeler code FDA assigned to United Natural Foods, Inc. dba UNFI; the middle segment (0279) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (53) 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 United Natural Foods, Inc. dba UNFI. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
United Natural Foods, Inc. dba UNFI 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 • 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 ▾
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 ▾
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
📦 Storage and Handling ▾
Other information • store at 20-25°C (68-77°F)
🧪 Active Ingredient ▾
Active ingredients (in each suppository) Cocoa butter 88.44% Phenylephrine HCl 0.25%
🧪 Inactive Ingredients ▾
Inactive ingredients methylparaben, propylparaben, topical starch Questions or comments? 1-855-423-2630
🎯 Purpose ▾
Purposes Protectant Vasoconstrictor
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.