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Doctor Butlers Hemorrhoid and Fissure External Pain Formula Lidocaine 5% 5 g/100g Cream, 28 g — NDC 70942-0121-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doctor Butlers Hemorrhoid and Fissure External Pain Formula Lidocaine 5% 5 g/100g Cream, 28 g — NDC 70942-121-11 (Billing 70942-0121-11)

by Beyond Health, P.A. · 28 g in 1 TUBE

This is a package of 28 g of Doctor Butlers Hemorrhoid and Fissure External Pain Formula Lidocaine 5% 5 g/100g Cream from Beyond Health, P.A., no longer marketed (first marketed Mar 2022), no longer in the FDA NDC Directory.

NDC 70942-0121-11
🏷️ FDA NDC (as labeled) 70942-121-11 billing pads the product segment with a zero
This package
Contains28 g Pack sizes4 compare ↓
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

NDC database record

One package, one record: these facts belong to NDC 70942-121-11 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70942 labeler · 121 product · 11 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7094212111 9
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70942-121-11
Product NDC 70942-121
11-digit billing NDC 70942012111
RxCUI 1366789
UNII 98PI200987
Application # M015
SPL Set ID d92f22a7-c0b5-d8b8-e053-2a95a90a2376
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
Marketing start 2022-03-01
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1366789
Why two NDCs? The FDA registers this code as 70942-121-11 — 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 → 70942-0121-11. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →
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.
Try another pack size: 21.3 g 28 g 42.5 g
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
70942-0121-01 70942-121-01 Main listing 28 g in 1 TUBE 2022-03-01 — Active
70942-0121-11 You're viewing this 28 g in 1 TUBE 2022-03-01 — Discontinued by firm
70942-0121-42 70942-121-42 42.5 g in 1 JAR 2022-03-01 — Active
70942-0121-75 70942-121-75 1 TUBE in 1 CARTON / 21.3 g in 1 TUBE 2025-07-22 — Active

Pack size FAQ

What quantity is in this package?
This package contains 28 g — 28 g in 1 tube.
How does this package differ from NDC 70942-0121-75?
Both are Doctor Butlers Hemorrhoid and Fissure External Pain Formula Lidocaine 5% 5 g/100g Cream — the drug itself is identical. This page's package is the 28 g one, while NDC 70942-0121-75 is the 1 tube package.
What NDC number is used to bill for this package of Doctor Butlers Hemorrhoid and Fissure External Pain Formula Lidocaine 5% 5 g/100g Cream?
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
Leader Maximum Strength Hemorrhoidal Relief 50 mg/g 70000-0650-01 Cardinal 1 tube $0.399 — Availability likely —
lidocaine 50 mg/g 75834-0333-30 Nivagen 30 g $0.399 — Availability likely —
Lidocaine 5% 5 g/100g 24689-0124-01 Apnar 1 tube $0.426 — FDA listed —
RectaSmoothe 5 g/100g 69315-0301-30 Leading 1 tube $0.458 — Discontinued —
Lidocaine Anorectal 50 mg/g 39328-0025-15 Patrin 1 tube $1.249 — Availability likely —
Walgreens Anorectal Lidocaine Cream 50 mg/g 00363-5722-28 Walgreens 1 tube — — FDA listed —
Lmx5 50 mg/g 00496-0883-15 Ferndale 15 g — — FDA listed —
Recticare 50 mg/g 00496-0892-15 Ferndale 15 g — — FDA listed —
Oxify 50 mg/g 11383-0002-06 Weeks 170 g — — FDA listed —
Oxify 50 mg/g 11383-0003-06 Weeks 170 g — — FDA listed —
Rite Aid Rectal Care 5 g/100g 11822-0265-01 Rite 1 tube — — FDA listed —
Anecream 5 5 g/100g 24357-0702-15 Focus 1 tube — — FDA listed —
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots 51316-0204-01 CVS 1 kit — — FDA listed —
Maximum Strength Hemorrhoidal Relief 50 mg/g 51316-0226-00 CVS 1 tube — — FDA listed —
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots 50 mg/g 51316-0229-00 CVS 1 tube — — FDA listed —
HemAway 1.5 g/30g 54473-0336-01 Melaleuca, 1 tube — — FDA listed —
Family Wellness Anorectal Lidocaine 50 mg/g 55319-0826-28 FAMILY 1 tube — — FDA listed —
Lidonumb .05 g/g 57237-0353-15 Rising 1 tube — — FDA listed —
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) 5 g/100g 60771-0027-01 Guangzhou 50 g — — FDA listed —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0028-01 Guangzhou 50 g — — FDA listed —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0029-01 Guangzhou 60 g — — FDA listed —
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0041-01 Guangzhou 60 g — — FDA listed —
Numb 520 5 g/100g 63742-0027-01 Clinical 1 bottle — — FDA listed —
Numb Master 50 mg/g 63742-0032-01 Clinical 1 bottle — — FDA listed —
Numb520 50 mg/g 63742-0033-01 Clinical 1 bottle — — FDA listed —
Numb25 50 mg/g 63742-0035-01 Clinical 38 g — — FDA listed —
Quick Numb 50 mg/g 63742-0333-01 Clinical 35.43 g — — FDA listed —
Numb and Number Anorectal Cream 5 g/100g 68848-0002-01 Dermtech 54 g — — FDA listed —
Rectal Care Cream 5 g/100g 69168-0484-02 Allegiant 1 tube — — FDA listed —
RectaEase Hemorrhoid Relief Cream 50 mg/g 69396-0070-01 Trifecta 1 tube — — FDA listed —
Retalief Lidocaine 5 .05 g/g 69618-0075-78 Reliable 1 tube — — FDA listed —
Zensa 5 g/100g 69805-0786-01 Alera 1 tube — — FDA listed —
Dr. Numb 1.5 g/30g 69903-0001-30 Shinpharma 1 tube — — FDA listed —
Dr. Numb .5 g/10g 69903-0004-10 Shinpharma 1 tube — — FDA listed —
Dr. Numb 5 g/100mL 69903-0006-02 Shinpharma 60 ml — — FDA listed —
Numbskin Maximum Strength Pain Reliever 5 g/100mL 69903-0008-30 Shinpharma 60 ml — — FDA listed —
Doctor Butlers Hemorrhoid and Fissure External Pain Formula 5 g/100gthis 70942-0121-11 Beyond 28 g — — Discontinued —
RectoProtect 5 g/100g 71399-0050-01 Akron 5 g — — FDA listed —
Curist Lidocaine Numbing Relief 5 g/100g 72559-0012-08 Little 170 g — — FDA listed —
Curist Lidocaine Relief 5 g/100g 72559-0024-32 Little 57 g — — FDA listed —
Numb 520 50 mg/g 72654-0033-02 Ebanel 125 g — — FDA listed —
Numb25 50 mg/g 72654-0035-01 Ebanel 38 g — — FDA listed —
Numb25 50 mg/g 72654-0036-02 Ebanel 125 g — — FDA listed —
Rectal Care Cream Revivol 5 g/100g 72839-0141-01 Derma 28 g — — FDA listed —
Moshe Numbing Hemorrhoidal 5 g/100g 72839-0218-01 Derma 42.5 g — — FDA listed —
Formula 2 Skin Care 5 g/100g 72839-0265-00 Derma 28 g — — FDA listed —
Hemorrhoid Relief Cream 50 mg/g 73492-0712-28 ALAINA 1 tube — — FDA listed —
Equate Hemorrhoid Relief 50 mg/g 79903-0109-30 WALMART, 1 tube — — FDA listed —
Lidocaine cream 5 g/100g 80489-0949-01 OL 1 tube — — FDA listed —
PUREGEN LABS Maximum Strength Lidocaine 50 mg/g 80513-0813-06 Advanced 170 g — — FDA listed —
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF 50 mg/mL 82460-0262-00 ALPHA 30 ml — — FDA listed —
Lidocaine 5% Cream 50 mg/g 82461-0420-30 Medcore 1 tube — — FDA listed —
HemRid Anorectal Cream 50 mg/g 82620-0001-01 KKA 1 tube — — FDA listed —
Adellina Lidocaine Numbing Cream Topical Anorectal Cream 5 g/100g 83566-0612-02 Guangdong 50 g — — FDA listed —
Lidocaine Numbing Cream .05 g/g 83602-0311-36 Guangzhou 1 jar — — FDA listed —
DR REAL NUMB Topical Anorectal 50 mg/g 83800-0430-00 FUZZYLULU 1 tube — — FDA listed —
Bloop Fissure Healing Anorectal Topical 5 g/100g 83838-0153-01 Three 1 tube — — FDA listed —
Dr. Care Numbing Cream 50 mg/g 84019-0038-01 Shengnan 30 g — — FDA listed —
Signature numbing cream 50 mg/g 84019-0039-01 Shengnan 10 g — — FDA listed —
Dr Wellskin Numbing Cream 50 mg/g 84019-0040-01 Shengnan 30 g — — FDA listed —
Signature numbing cream 50 mg/g 84019-0041-01 Shengnan 30 g — — FDA listed —
ETADERM Numbing Cream 5 g/100g 84180-0001-01 NUEPHASE 44 g — — FDA listed —
Bunnies Bum Hemorrhoidal Numbing 5 g/100g 84308-0159-01 FloCal 28 g — — FDA listed —
VBBV Anorectal(Hemorrhoidal) Creams 5 g/100mL 84867-0020-01 Jiashen 60 ml — — FDA listed —
Jakwork Numbing Cream 5 g/100g 85150-0001-01 Guangzhou 50 g — — FDA listed —
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream 5 g/100g 85248-0224-01 Jiangxi 50 g — — FDA listed —
Treatonic 5% Lidocaine Cream 3 g/60g 85569-0014-01 100 60 g — — FDA listed —
Lidocaine anorectal cream 5 g/100g 85833-0001-04 EveryMarket 1 jar — — FDA listed —
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) 4 g/80g 85833-0002-01 EveryMarket 80 g — — FDA listed —
Nupharmisto NumbMD 5% Lidocaine cream 4 g/80g 85833-0003-01 EveryMarket 80 g — — FDA listed —
Nupharmisto NumbMD Lidocaine Cream 4 g/80g 85833-0004-01 EveryMarket 80 g — — FDA listed —
Nupharmisto NumbMD Lidocaine Cream 4 g/80g 85833-0005-01 EveryMarket 80 g — — FDA listed —
NumbMD Lidocaine Cream Anorectal(hemorrhoidal) 3 g/60g 85833-0006-01 EveryMarket 60 g — — FDA listed —
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDAL 5 g/100g 87152-0002-01 Putian 50 g — — FDA listed —
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing 5 g/100g 87152-0003-01 Putian 50 g — — FDA listed —
tuiwaro LIDOCAINE Cream 5 g/100g 87408-0020-01 Guangzhou 1 bottle — — FDA listed —
Oudetas Lidocaine Cream 5 g/100g 87408-0022-01 Guangzhou 1 bottle — — FDA listed —
Numb Fast Hemorrhoidal 50 mg/mL 87459-0906-00 Oasis 1 tube — — FDA listed —
Topicaine 5 5 g/100g 63135-0581-04 ESBA 113 g — — FDA listed —
Lubricaine 5 5 g/100g 63135-0924-04 ESBA 113 g — — FDA listed —
Lipocaine 5 5 g/100g 63135-0811-04 ESBA 113 g — — FDA listed —
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum 5 g/100g 73287-0040-01 Telebrands 1 jar — — 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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.

💡 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 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII X765CF609L
    A plant-derived ingredient from hickory bark used as a flavoring agent and natural additive in medications. It may contribute subtle taste or aroma to make the medicine more palatable.
  • UNII 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII T07U1161SV
    A plant extract from witch hazel leaves, used in medicines as a natural astringent and skin-soothing agent. It helps reduce irritation and is often included in topical formulations for its mild anti-inflammatory properties.
  • UNII P62Y550X24
    A plant extract from helichrysum flowers that may be used as a natural fragrance, flavor enhancer, or colorant in medicines. It contributes aroma or taste to make the medication more pleasant.
  • 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 H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 19AH1RAF4M
    A plant extract from lavender flowers used as a flavoring and fragrance agent in medicines. It adds taste and aroma to make the product more pleasant to take.
  • UNII G0R4UBI2ZZ
    Matricaria chamomilla, commonly known as chamomile, is a plant extract used in medicines as a flavoring agent and natural fragrance component. It may also provide mild soothing properties to the formulation.
  • UNII G43C57162K
    A natural plant extract from tea tree leaves used in topical formulations. It acts as a fragrance, preservative, and antimicrobial agent to help maintain product freshness and sensory appeal.
  • UNII MJ95C3OH47
    A plant extract from olive leaves used in formulations as an antioxidant and preservative. It helps protect the medicine from degradation and extend shelf life.
  • 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 IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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.

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

The official label also statesAesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.

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.

Manufacturer & labeler

LabelerBeyond Health, P.A.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code70942
First marketedMar 2022
Product typeHuman Otc Drug
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 14 words ▾

Uses Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

⏱️ Dosage and Administration 57 words ▾

Directions When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

⚠️ Warnings 121 words ▾

Warnings For external use only including the skin of the anal canal When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reactions to ilgredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding ask a health care professional before use Keep out of reach of children.

If swallowed, seek medical help or contact a Poison Control Cener right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Lidocaine USP 5.0%

🧪 Inactive Ingredients 80 words ▾

Inactive ingredients Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.

🎯 Purpose 4 words ▾

Purpose Analgesic (pain reliever)

📄 When Using This Product 35 words ▾

When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator

📄 Stop Use and Ask a Doctor If 44 words ▾

Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reactions to ilgredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 11 words ▾

0.75oz / 21.3g tube PDP

1.5oz / 42.5g jar pdp_jar

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 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 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (70942-0121-75), 28 g (70942-0121-01), 42.5 g (70942-0121-42). 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.
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.