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Thera Plus Hemorrhoidal GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE 144 mg/g; 150 mg/g; 2.5 mg/g; 10 mg/g Cream, 26 g — NDC 80684-0141-00 package photo

Thera Plus Hemorrhoidal GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE 144 mg/g; 150 mg/g; 2.5 mg/g; 10 mg/g Cream, 26 g

by FOURSTAR GROUP USA, INC. · 26 g in 1 TUBE (80684-141-00)
NDC 80684-0141-00
🏷️ FDA NDC (as labeled) 80684-141-00 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 80684-141-00
Product NDC 80684-141
11-digit billing NDC 80684014100
RxCUI 1293649
UNII PDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 88AYB867L5
UPC 0049696700429
Application # M015
SPL Set ID 87143a7a-7b2d-4b67-afda-2355697e7300
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-03
Route TOPICAL
Dosage form CREAM
Substance GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 80684-141-00 — 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 → 80684-0141-00. 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.

🏷️ RxNorm drug class

This medicine belongs to the Local anesthetics class.

Drug family (ATC) Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerFOURSTAR GROUP USA, INC.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code80684
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio147 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

🧪 What is this product?

This is an over-the-counter hemorrhoidal cream containing four active ingredients. Phenylephrine hydrochloride is a decongestant that is typically used to reduce swelling and shrink blood vessels in the affected area. Pramoxine hydrochloride is a topical anesthetic commonly used to numb pain and itching. Glycerin and petrolatum function as emollients and protectants, helping to soften tissue and create a protective barrier on the skin.

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.

🧪 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

11 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesaloe barbadensis leaf juice, carboxymethycellulose sodium, cetyl alcohol, mono-and di-glycerides, methylparaben, mineral oil, propylene glycol, propylparaben, purified water, stearic acid,tween 80, xanthan gum

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Hemorrhoidal Maximum Strength Pain Relief 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 00113-0944-24 L. 1 tube $0.045 — Availability likely —
Hemorrhoidal Cream .28 g/28g; 4.032 g/28g; .07 g/28g; 4.2 g/28g 70000-0425-01 Cardinal 1 tube $0.085 — Availability likely —
GNP Hemorrhoidal Maximum Strength 150 mg/g; 144 mg/g; 10 mg/g; 25 mg/g 46122-0776-37 Amerisourcebergen 1 tube $0.130 — Availability likely —
Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/g 00363-0641-09 Walgreens 1 tube — — FDA listed —
Hemorrhoidal Pain Relief Cream 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 00363-9127-01 WALGREENS 1 tube — — FDA listed —
PREPARATION H Maximum Strength 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 00573-2868-10 Haleon 1 tube — — FDA listed —
Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 11822-2944-00 Rite 1 tube — — Discontinued —
Hemorrhoidal Pain Relief 10 mg/g; 2.5 mg/g; 144 mg/g; 150 mg/g 13709-0335-01 Neilmed 1 tube — — FDA listed —
Signature Care Hemorrhoidal Cream (with applicator) 2.5 mg/g; 10 mg/g; 144 mg/g; 150 mg/g 21130-0981-02 BETTER 1 tube — — FDA listed —
hemorrhoidal maximum strength pain relief 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 30142-0944-24 Kroger 1 tube — — FDA listed —
topcare hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 36800-0944-24 Topco 1 tube — — FDA listed —
Equaline Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 41163-0944-24 United 1 tube — — FDA listed —
hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 41250-0944-24 Meijer 1 tube — — FDA listed —
Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 42507-0944-24 HyVee 1 tube — — FDA listed —
equate hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 49035-0944-24 Wal-Mart 1 tube — — FDA listed —
Nikzon Hemorrhoidal 144 mg/g; 150 mg/g; 2.5 mg/g; 10 mg/g 50066-0010-09 Genomma 1 tube — — FDA listed —
CVS Maximum OTC Strength Hemorrhoidal with Aloe 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 51316-0203-01 CVS 28 g — — FDA listed —
Family Wellness HEMORRHOID 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 55319-0981-25 FAMILY 1 tube — — FDA listed —
Family Wellness 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 55621-0012-01 Zhejiang 1 tube — — FDA listed —
hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 56062-0944-24 Publix 1 tube — — FDA listed —
Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 59779-0944-24 CVS 1 tube — — FDA listed —
Hemorrhoidal Cream 1 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 69396-0033-18 Trifecta 1 tube — — FDA listed —
Hemorrhoidal Cream 1 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 69396-0171-18 Trifecta 1 tube — — FDA listed —
Family Wellness 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 69571-0004-02 FRONT 1 tube — — FDA listed —
CVS Health Hemorrhoidal Cream 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 69571-0010-28 FRONT 1 tube — — FDA listed —
Thera Plus Hemorrhoidal 144 mg/g; 150 mg/g; 2.5 mg/g; 10 mg/gthis 80684-0141-00 FOURSTAR 26 g — — FDA listed —
Thera Plus Hemorrhoidal 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 80684-0210-01 Fourstar 26 g — — FDA listed —
Up and Up Hemorrhoid MAX STRENGTH 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 82442-0025-51 Target 1 tube — — FDA listed —
Hemorrhoidal Cream with Aloe 15 g/100g; .25 g/100g; 1 g/100g; 14.4 g/100g 83324-0044-09 Chain 1 tube — — FDA listed —
Maximum Strength Hemorrhoidal Cream with Aloe 15 g/100g; .25 g/100g; 1 g/100g; 14.4 g/100g 83324-0330-01 Chain 1 tube — — FDA listed —
Bloop Hemorrhoid Relief Topical 14.4 g/100g; 1 g/100g; 15 g/100g; .25 g/100g 83838-0155-01 Three 1 tube — — 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80684-0141-00 You're viewing this 26 g in 1 TUBE (80684-141-00) 2025-03-03 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 ✓ 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 80684-141-00, 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: 80684-0141-00, written without dashes as 80684014100. 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 80684-0141-00, the first segment (80684) is the labeler code FDA assigned to FOURSTAR GROUP USA, INC.; the middle segment (0141) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 FOURSTAR GROUP USA, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FOURSTAR GROUP USA, 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.

📄 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
🎯 Indications and Usage 47 words ▾

Uses for temporary relief of pain, soreness and burning helps relieve the local itching and discomfort associated with hemorrhoids temporarily provides a coating for relief of anorectal discomforts temporarily protects the in amed irritated anorectal surface to help make bowel movements less painful temporarily shrinks hemorrhoidal tissue

⏱️ Dosage and Administration 108 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. apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement. apply externally or in the lower portion of the anal canal only. for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube.Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.

Children under 12 years of age: consult a doctor.

⚠️ Warnings 138 words ▾

Warnings For external use only. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes urinating due to an enlarged prostate gland When using this product do not put this product into the rectum by using fingers or any mechanical device or applicator do not exceed 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 the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. some people can develop allergic reactions to ingredients in this product.

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).

🧪 Active Ingredient 17 words ▾

Active ingredients Glycerol 14.4% Petrolatum 15% Phenylephrine hydrochloride 0.25% Pramoxine hydrochloride 1% Purpose Protectant Vasoconstrictor Local anesthetic

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients aloe barbadensis leaf juice, carboxymethycellulose sodium, cetyl alcohol, mono-and di-glycerides, methylparaben, mineral oil, propylene glycol, propylparaben , purified water, stearic acid,tween 80, xanthan gum

🎯 Purpose 5 words ▾

Purpose Protectant Vasoconstrictor Local anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80684-0140-00 · FOURSTAR 80684-0142-00 · FOURSTAR →
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.