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Dr Butlers Hemorrhoid and Fissure PF Lidocaine 4.00, Phenylephrine Hydrochloride 0.25 4 g/100g; .25 g/100g Ointment — NDC 70942-0357-01 package photo

Dr Butlers Hemorrhoid and Fissure PF Lidocaine 4.00, Phenylephrine Hydrochloride 0.25 4 g/100g; .25 g/100g Ointment

by Beyond Health P.A. · 1 TUBE in 1 CARTON (70942-357-01) / 28 g in 1 TUBE
NDC 70942-0357-01
🏷️ FDA NDC (as labeled) 70942-357-01 billing pads the product segment with a zero
This package
Contains28 g in 1 tube Pack sizes4 compare ↓
Also comes in: 42.5 g 70942-0357-15 21.3 g 70942-0357-75 12 packets 70942-0357-12
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) 70942-357-01
Product NDC 70942-357
11-digit billing NDC 70942035701
RxCUI 2673304
UNII 98PI200987, 04JA59TNSJ
Application # M015
SPL Set ID f526199e-5c9e-7a3c-e053-2a95a90aa98e
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 On market
FDA listing status Listed (active directory)
Marketing start 2023-02-20
Route TOPICAL
Dosage form OINTMENT
Substance LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
GCN Seq No 088180
GCN 58276
HICL code 049097
Ingredient (HICL) Lidocaine/Phenylephrine Hcl
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 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name HEMORRHOID-FISSURE OINTMENT
FDB brand name Hemorrhoid-Fissure
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70942-357-01 — 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 → 70942-0357-01. 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

LabelerBeyond Health P.A.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code70942
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio4 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

Label name HEMORRHOID-FISSURE OINTMENT Ingredient Lidocaine/Phenylephrine Hcl
🧪 What is this product?

Dr Butler's Hemorrhoid and Fissure is a topical ointment marketed as an over-the-counter monograph drug. It contains lidocaine, a local anesthetic commonly used to numb tissue and reduce pain, and phenylephrine hydrochloride, a decongestant typically used to reduce swelling and shrink blood vessels in affected areas. This combination is formulated for topical application to the skin around the rectal 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.

🧪 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • 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 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 1C6V77QF41
    Cholecalciferol is vitamin D3, a fat-soluble vitamin added to medicines as a nutritional supplement or active ingredient fortification. It helps the body absorb calcium and support bone health.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII WI4X0X7BPJ
    A synthetic steroid hormone used as the active therapeutic ingredient in this medicine. It reduces inflammation and suppresses immune responses to treat conditions like skin irritation, allergies, and hormonal deficiencies.
  • UNII 15E7C67EE8
    A natural seaweed extract used as a thickener and gelling agent in medicines. It helps create the right texture and consistency in liquid or semi-solid formulations.
  • UNII JNJ23Q2COM
    Lysine hydrochloride is an amino acid salt used in medicines as a buffer and pH stabilizer. It helps maintain the acidity level of the product to keep the active ingredient stable and effective.
  • UNII SA8AR2W4ER
    A natural oil extracted from chamomile flower tops, used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • 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 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 14AN0J70WO
    A red seaweed extract used as a natural binder and thickener in medications. It helps hold tablet ingredients together and may improve the texture of liquid 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 CLV24I3T1D
    A plant extract from pomegranate root bark used as a natural coloring agent and flavoring component in medicines. It may also help preserve the product and provide mild astringent properties to the formulation.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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.

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

The official label also statesAesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide

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.
Try another pack size: 42.5 g 21.3 g 12 packets
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
Hemorrhoid Master 4 mg/g; 2.5 mg/g 63742-0045-01 Clinical 45 g — — FDA listed —
Dr Butlers Hemorrhoid and Fissure PF 4 g/100g; .25 g/100gthis 70942-0357-01 Beyond 1 tube — — FDA listed —
Hemorrhoid Master 40 mg/g; 2.5 mg/g 72654-0002-01 Ebanel 45 g — — FDA listed —
RRHOID RAGE Hemorrhoidal 40 mg/g; 2.5 mg/g 82433-0446-00 POPPY 1 tube — — FDA listed —
The Femme Fix Hemorrhoid Treatment 40 mg/g; 2.5 mg/g 82433-0946-00 POPPY 1 tube — — FDA listed —
Liposomal Hemorrhoid Master 4 g/100g; .25 g/100g 84735-0008-01 Hengyang 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70942-0357-01 You're viewing this 1 TUBE in 1 CARTON (70942-357-01) / 28 g in 1 TUBE 2023-02-20 Active
70942-0357-12 12 PACKET in 1 CARTON (70942-357-12) / 2 g in 1 PACKET (70942-357-06) 2023-02-20 Active
70942-0357-15 1 TUBE in 1 CARTON (70942-357-15) / 42.5 g in 1 TUBE (70942-357-05) 2025-12-01 Active
70942-0357-75 1 TUBE in 1 CARTON (70942-357-75) / 21.3 g in 1 TUBE (70942-357-07) 2025-07-22 Active

Pack size FAQ

What quantity is in NDC 70942-0357-01?
NDC 70942-0357-01 is listed by the FDA — 1 tube in 1 carton / 28 g in 1 tube.
What NDC number is used to bill for this package of Dr Butlers Hemorrhoid and Fissure PF Lidocaine 4.00, Phenylephrine Hydrochloride 0.25 4 g/100g; .25 g/100g Ointment?
Bill NDC 70942-0357-01 — the 11-digit billing format is 70942035701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 70942-357-01, 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: 70942-0357-01, written without dashes as 70942035701. 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 70942-0357-01, the first segment (70942) is the labeler code FDA assigned to Beyond Health P.A.; the middle segment (0357) 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.
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 Beyond Health P.A.. 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 3 other package presentations of this same product, including 1 tube (70942-0357-15), 1 tube (70942-0357-75), 12 packets (70942-0357-12). 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?
Beyond Health P.A. 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 24 words ▾

Uses temporarily shrinks hemorrhoidal tissue for the temporary relief of pain, soreness, or burning helps relieve the local itching and discomfort associated with hemorrhoids

⏱️ Dosage and Administration 82 words ▾

Directions children under 12 years of age consult your pediatrician. adults: apply to affected area up to 4 times daily. cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use. to use dispensing cap, attach it to tube, lubricate well, then apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly

⚠️ Warnings 169 words ▾

Warnings For external use only including the skin of the anal canal. When using this product do not exceed recommended dosage unless directed by a doctor when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum Ask a doctor before use if you have allergies to any of the components of this product difficulty in urination due to enlargement of the prostate gland Diabetes Heart Disease High Blood Pressure Thyroid Disease presently taking a prescription for high blood pressure or depression Stop use and ask a doctor if condition worsens or does not improve within seven (7) days bleeding occurs an allergic reation develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding as a health care professional before use.

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

🧪 Active Ingredient 8 words ▾

Active Ingredients Lidocaine USP 4% Phenylephrine HCl 0.25%

🧪 Inactive Ingredients 78 words ▾

Inactive Ingedients Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide

🎯 Purpose 5 words ▾

Purpose Analgesic (pain relief) Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70942-0200-03 · Beyond 70942-0517-01 · Beyond →
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.