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Treatonic hemorrhoid treatment 5% lidocaine 2.5 g/50g; .125 g/50g Cream, 50 g — NDC 85569-0008-01 package photo

Treatonic hemorrhoid treatment 5% lidocaine 2.5 g/50g; .125 g/50g Cream, 50 g

by 100 KARMA INC · 50 g in 1 CARTON (85569-008-01)
NDC 85569-0008-01
🏷️ FDA NDC (as labeled) 85569-008-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 85569-008-01
Product NDC 85569-008
11-digit billing NDC 85569000801
RxCUI 1314136
UNII 98PI200987, 04JA59TNSJ
UPC 0860014405129
Application # M015
SPL Set ID 41442fa7-c511-07ca-e063-6294a90a3992
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2025)
Marketing start 2025-10-31
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 85569-008-01 — 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 → 85569-0008-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, 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

Labeler100 KARMA INC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code85569
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio15 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?

Treatonic is a topical cream for over-the-counter use that contains lidocaine and phenylephrine hydrochloride. Lidocaine is a local anesthetic typically used to numb pain and itching in the area where it is applied. Phenylephrine hydrochloride is a decongestant that functions to narrow blood vessels, which is commonly used to reduce swelling and discomfort. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of hemorrhoid treatment products.

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII B66F4574UG
    A plant-derived ingredient from Chinese angelica root, used as a natural flavoring and fragrance agent in medicines. It may also serve as a traditional ingredient to support formulation stability.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII K48IKT5321
    A plant extract from clove buds used as a flavoring agent and natural fragrance in medications. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII VT53B5BP4G
    A plant extract from dendrobium orchid stems, traditionally used in herbal medicine. In pharmaceuticals, it may serve as a natural ingredient to support formulation texture or provide botanical content, though its specific technical role depends on the product type.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII GXZ33VNT92
    Gentiana scabra root is a plant extract used in some formulations as a flavoring agent and natural colorant. It may also serve to support the product's stability and shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII 42B5YD8F0K
    A plant extract from licorice root used in traditional medicine. In formulations, it may serve as a flavoring agent, sweetener, or soothing ingredient to improve taste and texture.
  • UNII 3C18L6RJAZ
    A plant extract from horse chestnut seeds used in formulations as a natural thickening agent and binder. It helps hold tablet or capsule ingredients together and may improve product texture.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 1L24V9R23S
    Potassium alum is a mineral salt used in medicines as an astringent agent and buffering ingredient. It helps control moisture, maintain pH balance, and can reduce irritation in topical or oral formulations.
  • 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 1693AM5SBN
    Salvia miltiorrhiza root is a plant extract used in traditional medicine formulations. It may serve as a flavoring agent, natural colorant, or functional ingredient to support the product's intended therapeutic profile.
  • UNII H51N91QNEB
    A plant extract from the smilax glabra vine used in traditional medicine preparations. It may function as a natural flavoring agent, botanical extract, or ingredient to support the product's intended formulation characteristics.
  • UNII 48PS81XHK0
    A plant-derived ingredient from the root of Stephania tetrandra, a climbing vine used in traditional medicine. In formulations, it may function as a natural extract or botanical filler.
  • UNII 8M03K6M7S8
    A plant extract from Japanese yew leaves used in formulations as a natural ingredient. It may serve roles such as an antioxidant or preservative to help maintain product stability.
  • 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 SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesWater, Ethylhexyl Palmitate, Zinc Oxide, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Gentiana Scabra Root Extract, Centella Asiatica Extract, Menthol, PEG-100 Stearate, Carbomer, Allantoin, Salvia Miltiorrhiza Root Extract, Angelica Polymorpha Sinensis Root Extract, Eugenia Caryophyllus (Clove) Bud Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Dendrobium Officinale Stem Extract, Stephania Tetrandra Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Taxus Cuspidata Leaf Extract, Smilax Glabra Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Potassium Alum, Caprylhydroxamic Acid, Phenoxyethanol.

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
Liposomal Hemorrhoid Master 5 g/100g; .25 g/100g 63742-0038-01 Clinical 1 tube — — FDA listed —
Hemorrohoid Master Cream 50 mg/g; 2.5 mg/g 72654-0038-01 Ebanel 45 g — — FDA listed —
Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine HCL 0.25% 5 g/100g; .25 g/100g 73715-0007-01 Mohnark 30 g — — Discontinued —
tina davies IceCream Hemorrhoidal 5 g/100mL; .25 g/100mL 84313-0002-15 TINA 1 tube — — FDA listed —
tina davies IceJelly Hemorrhoidal 5 g/100mL; .25 g/100mL 84313-0101-30 TINA 1 tube — — FDA listed —
Treatonic hemorrhoid treatment 2.5 g/50g; .125 g/50gthis 85569-0008-01 100 50 g — — Discontinued —
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
Oct 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.

🔬 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 Treatonic hemorrhoid treatment (this brand).

Top reported reactions

Pallor7
Abdominal Pain1
Blood Pressure Decreased1
Chills1
Convulsion1
Death1
Drug Administered To Patient Of Inappropriate Age1

Age at onset

Adult3

Reporter sex

16 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization4
Death2
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 0
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 NDCDescription Marketing startStatus
85569-0008-01 You're viewing this 50 g in 1 CARTON (85569-008-01) 2025-10-31 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 85569-008-01, 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: 85569-0008-01, written without dashes as 85569000801. 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 85569-0008-01, the first segment (85569) is the labeler code FDA assigned to 100 KARMA INC; the middle segment (0008) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
100 KARMA 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 84 words ▾

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. Children under 12 years of age: consult a doctor.

For External use: Apply externally to the affected area up to 4 times daily. For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum.

Apply to the affected area up to 4 times daily.

⏱️ Dosage and Administration 42 words ▾

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation. For the temporary reliefofpain, burning and soreness. Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.

⚠️ Warnings 173 words ▾

For external and / or intrarectal use only. Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly. lf the condition worsens or does not improve within 7 days, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor.

In case of bleeding, consult a doctor promptly. Certain persons can develop allergic reactions to ingredients in this product. If the symptombeing treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Keep out of reach of children, if swallowed, get medical help or contact poison control center right away.

🧪 Active Ingredient 5 words ▾

Lidocaine 5% Phenylephrine HCI 0.25%

🧪 Inactive Ingredients 75 words ▾

Water, Ethylhexyl Palmitate, Zinc Oxide, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Gentiana Scabra Root Extract, Centella Asiatica Extract, Menthol, PEG-100 Stearate, Carbomer, Allantoin, Salvia Miltiorrhiza Root Extract, Angelica Polymorpha Sinensis Root Extract, Eugenia Caryophyllus (Clove) Bud Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Dendrobium Officinale Stem Extract, Stephania Tetrandra Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Taxus Cuspidata Leaf Extract, Smilax Glabra Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Potassium Alum, Caprylhydroxamic Acid, Phenoxyethanol.

🎯 Purpose 3 words ▾

Topical anesthetic Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85569-0007-01 · 100 85569-0009-01 · 100 →
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.