Home › NDC Lookup › Ingredients › Calamine, Petrolatum And Phenylephrine H... › 55614-0610-01
🧴image loading
(from DailyMed)

FARGELIN HEMORRHOIDAL Calamine, Petrolatum and Phenylephrine hydrochloride 10.3 g/100g; .05 g/100g; 79.25 g/100g; .25 g/100g Ointment, 20 g — NDC 55614-610-01 (Billing 55614-0610-01)

by MADISON ONE ACME INC · 20 g in 1 TUBE, WITH APPLICATOR

This is a package of 20 g of FARGELIN HEMORRHOIDAL Calamine, Petrolatum and Phenylephrine hydrochloride 10.3 g/100g; .05 g/100g; 79.25 g/100g; .25 g/100g Ointment from MADISON ONE ACME INC, marketed since Nov 2019 and currently FDA-listed. It is this product's only package size.

NDC 55614-0610-01
🏷️ FDA NDC (as labeled) 55614-610-01 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 Aug 27, 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 55614-610-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55614 labeler · 610 product · 01 package
Package marketed since
Nov 27, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5561461001 6
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55614-610-01
Product NDC 55614-610
11-digit billing NDC 55614061001
UNII SOI2LOH54Z, 1K09F3G675, 4T6H12BN9U, 04JA59TNSJ
Application # M015
SPL Set ID 6844ad63-512d-496a-9458-011894185b0d
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 2019-11-27
Route RECTAL, TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE; FERRIC OXIDE RED; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 55614-610-01 — 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 → 55614-0610-01. 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?

Fargelin Hemorrhoidal is a topical rectal ointment sold as an over-the-counter monograph product. It contains phenylephrine hydrochloride, a decongestant that is typically used to reduce swelling, along with petrolatum and zinc oxide, which function as moisturizers and skin protectants. Ferric oxide red serves as a coloring agent. This combination is intended for localized use in the hemorrhoid 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 gPer 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
55614-0610-01 You're viewing this Main listing 20 g in 1 TUBE, WITH APPLICATOR 2019-11-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fargelin Hemorrhoidal 10.3 g/100g; .05 g/100g; 79.25 g/100g; .25 g/100gthis 55614-0610-01 MADISON 20 g — — 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
Nov 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

LabelerMADISON ONE ACME INC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code55614
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from MADISON ONE ACME INC labeler code 55614

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 35 words ▾

Uses temporarily helps relieve: anorectal burning, itching, and discomfort associated with hemorrhoids temporarily: reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders shrinks hemorrhoidal tissue protects inflamed perianal skin and irritated areas

⏱️ Dosage and Administration 109 words ▾

Directions adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily.

FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum.

Remove and discard used applicator. Apply to the affected area up to 4 times daily. children under 12 years of age: consult a doctor.

⚠️ Warnings 5 words ▾

Warnings For rectal use only

📦 Storage and Handling 30 words ▾

Other information keep container tightly closed store at room temperature 20 - 25 C (68 - 77 F) do not use if the physical properties of this product have changed

🧪 Active Ingredient 9 words ▾

Active ingredients Calamine 10.5% Petrolatum 79.25% Phenylephrine hydrochloride 0.25%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Amber, callicarpa nudiflora leaf, corydalis yanhusuo tuber, lanolin, panax notoginseng root, pearl, sanguisorba officinalis root, scutellaria baicalensis root, sodium borate, and styphnolobium japonicum flower.

🎯 Purpose 10 words ▾

Purpose Hemorrhoidal (anorectal) astringent/protectant Hemorrhoidal (anorectal) protectant Hemorrhoidal (anorectal) vasoconstrictor

📄 Ask a Doctor Before Use If 26 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 46 words ▾

When using this product in case of bleeding; consult a doctor promptly do not exceed the recommended daily dosage unless directed by a doctor do not use with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

📄 Stop Use and Ask a Doctor If 16 words ▾

Stop use and ask a doctor if condition worsens symptoms do not improve within 7 days

🤰 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.

📄 Questions or Comments 11 words ▾

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

📄 Package Label / Principal Display Panel 10 words ▾

FARGELIN HEMORRHOIDAL OINTMENT NDC 55614-610-01 0.705 oz (20 g) box-02.jpg

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 MADISON ONE ACME INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MADISON ONE ACME INC 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.
← 55614-0600-01 · MADISON 55614-0620-01 · MADISON →
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.