Home › NDC Lookup › Ingredients › Cocoa Butter, Phenylephrine Hcl › 36800-0279-53
💊image loading
(from DailyMed)

topcare hemorrhoidal cocoa butter, phenylephrine HCl 2211 mg; 6.5 mg Suppository, 12 suppositories — NDC 36800-279-53 (Billing 36800-0279-53)

by Topco Associates LLC · 12 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK

This is a package of 12 suppositories of topcare hemorrhoidal cocoa butter, phenylephrine HCl 2211 mg; 6.5 mg Suppository from Topco Associates LLC, marketed since Nov 2014 and currently FDA-listed. It is this product's only package size.

NDC 36800-0279-53
🏷️ FDA NDC (as labeled) 36800-279-53 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-279-53
Product NDC 36800-279
11-digit billing NDC 36800027953
NCPDP billing unit EA — each (per item)
RxCUI 1438497
UNII 512OYT1CRR, 04JA59TNSJ
Application # M015
SPL Set ID 81a3546b-5099-4b9a-b774-b3e79316b267
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 2014-11-03
Route RECTAL
Dosage form SUPPOSITORY
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 071662
  • GCN: 35585
  • GPI-14 (Medi-Span): 89994002335225
  • HICL (First Databank): 040185
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1438497
Why two NDCs? The FDA registers this code as 36800-279-53 — 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 → 36800-0279-53. 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.

Clinical

Label name 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 protectant for rectal tissue, and phenylephrine hydrochloride, a decongestant typically used to reduce swelling and discomfort associated with hemorrhoids. The combination is commonly used to provide temporary relief of symptoms such as itching, pain, and swelling in the hemorrhoidal area.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
36800-0279-53 You're viewing this Main listing 12 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK 2014-11-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Hemorrhoidal 2211 mg/1; 6.5 mg 00113-0279-53 L. 12 suppositories $0.288 — Availability likely —
rugby hemorrhoidal 2211 mg/1; 6.5 mg 00536-1186-12 Rugby 12 suppositories $0.288 — Availability likely —
Hemorrhoidal 2.39 g/1; 6.75 mg 46122-0777-65 Amerisourcebergen 12 suppositories $0.288 — Availability likely —
Leader Hemorrhoidal 2211 mg/1; 6.5 mg 70000-0223-01 Cardinal 12 suppositories $0.288 — Availability likely —
foster and thrive hemorrhoidal 2211 mg/1; 6.5 mg 70677-1292-01 Strategic 12 suppositories $0.288 — 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 mgthis 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

🏛️
2014
On the market since
Nov 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.

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.

Manufacturer & labeler

LabelerTopco Associates LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedNov 2014
Product typeHuman Otc Drug
Portfolio408 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.

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 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 137 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

⚠️ Warnings 124 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.

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 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 6 words ▾

Inactive ingredients methylparaben, propylparaben, topical starch

🎯 Purpose 3 words ▾

Purposes Protectant Vasoconstrictor

📄 Ask a Doctor Before Use If 31 words ▾

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 21 words ▾

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 16 words ▾

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

📄 Stop Use and Ask a Doctor If 20 words ▾

Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 58 words ▾

Package/Label Principal Display Panel TopCare ® health COMPARE TO PREPARATION H ® SUPPOSITORIES ACTIVE INGREDIENTS NIGHTTIME RELIEF Hemorrhoidal Suppositories ● Reduces Internal Swelling. Soothes and Protects ● Prompt Soothing Relief from Painful Burning, Itching and Discomfort ● Shrinks Swollen Hemorrhoidal Tissue ● Protects Irritated Tissue 12 SUPPOSITORIES E-Z OPEN WRAPPER hemorrhoidal suppositories image 1 hemorrhoidal suppositories image 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates 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.
← 36800-0278-11 · TOPCO 36800-0280-11 · TOPCO →
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.