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Hemorrhoidal Cocoa Butter, Phenylephrine HCl 2.39 g; 6.75 mg Suppository, 24 suppositories — NDC 68016-322-24 (Billing 68016-0322-24)

by Pharmacy Value Alliance LLC · 4 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK

This is a package of 24 suppositories of Hemorrhoidal Cocoa Butter, Phenylephrine HCl 2.39 g; 6.75 mg Suppository from Pharmacy Value Alliance LLC, marketed since Aug 2019 and currently FDA-listed.

NDC 68016-0322-24
🏷️ FDA NDC (as labeled) 68016-322-24 billing pads the product segment with a zero
This package
Contains24 suppositories Pack sizes2 compare ↓
Product page 68016-0322-12 Also comes in: 12 suppositories 68016-322-12
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

NDC database record

One package, one record: these facts belong to NDC 68016-322-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68016 labeler · 322 product · 24 package
Package marketed since
Aug 16, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0840986034190
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-322-24
Product NDC 68016-322
11-digit billing NDC 68016032224
UNII 512OYT1CRR, 04JA59TNSJ
UPC 0840986034190
Application # M015
SPL Set ID 903b77fc-02bf-73b6-e053-2a95a90ad4cc
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 2019-08-16
Route RECTAL
Dosage form SUPPOSITORY
Substance COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 68016-322-24 — 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 → 68016-0322-24. 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

🧪 What is this product?

This is a rectal suppository product containing cocoa butter and phenylephrine hydrochloride, marketed under FDA's OTC monograph rules for hemorrhoidal treatments. Phenylephrine is a decongestant that functions to reduce swelling and shrink blood vessels in the affected area. Cocoa butter serves as a lubricating and soothing base that also helps the suppository dissolve and be absorbed into the tissue. Products of this type are typically used to address discomfort, itching, and swelling 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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68016-0322-12 68016-322-12 Main listing 2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK 2019-08-16 — Active
68016-0322-24 You're viewing this 4 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK 2019-08-16 — Active

Pack size FAQ

What quantity is in this package?
This package contains 24 suppositories — 4 blister pack in 1 carton / 6 suppository in 1 blister pack.
How does this package differ from NDC 68016-0322-12?
Both are Hemorrhoidal Cocoa Butter, Phenylephrine HCl 2.39 g; 6.75 mg Suppository — the drug itself is identical. This page's package is the 24 suppositories one, while NDC 68016-0322-12 is the 12 suppositories package.
What NDC number is used to bill for this package of Hemorrhoidal Cocoa Butter, Phenylephrine HCl 2.39 g; 6.75 mg Suppository?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hemorrhoidal 2.39 g/1; 6.75 mg 46122-0777-65 Amerisourcebergen 12 suppositories $0.288 — Availability likely —
Hemorrhoidal 2.39 g/1; 6.75 mg 69842-0785-48 CVS 48 suppositories — — FDA listed —
Hemorrhoidal 2.39 g/1; 6.75 mgthis 68016-0322-24 Pharmacy 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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

LabelerPharmacy Value Alliance LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio19 products on file

More NDCs from Pharmacy Value Alliance LLC labeler code 68016

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 47 words ▾

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 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

📄 Ask a Doctor Before Use If 26 words ▾

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

📄 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 35 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Other Information 15 words ▾

Other information Store at room temperature or in a cool place but not over 80°F

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-492-5988

📄 Package Label / Principal Display Panel 42 words ▾

The product package shown below represents a sample of that currently in use. Additional packaging may also be available. Premier Value Hemorrhoidal Suppositories 12ct Distributed by Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087 785PVHemSupp.jpg Premier Value Hemorrhoidal Suppositories

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 Pharmacy Value Alliance 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 (68016-0322-12). 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?
Pharmacy Value Alliance 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.
← 68016-0320-05 · Premier 68016-0342-06 · Chain →
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.