Home › NDC Lookup › Ingredients › Lidocaine 5% › 72654-0035-01
Numb25 Lidocaine 5% 50 mg/g Cream, 38 g — NDC 72654-0035-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Numb25 Lidocaine 5% 50 mg/g Cream, 38 g — NDC 72654-035-01 (Billing 72654-0035-01)

by Ebanel Laboratories, Inc · 38 g in 1 BOTTLE, PLASTIC

This is a package of 38 g of Numb25 Lidocaine 5% 50 mg/g Cream from Ebanel Laboratories, Inc, marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 72654-0035-01
🏷️ FDA NDC (as labeled) 72654-035-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 72654-035-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
72654 labeler · 035 product · 01 package
Package marketed since
May 13, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7265403501 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72654-035-01
Product NDC 72654-035
11-digit billing NDC 72654003501
RxCUI 1366789
UNII 98PI200987
Application # M015
SPL Set ID 350fd302-8fd5-5288-e063-6294a90aa382
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 2025-05-13
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1366789
Why two NDCs? The FDA registers this code as 72654-035-01 — 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 → 72654-0035-01. 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.

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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72654-0035-01 You're viewing this Main listing 38 g in 1 BOTTLE, PLASTIC 2025-05-13 — Active

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/100g 70942-0121-01 Beyond 28 g — — FDA listed —
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/gthis 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 —
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
May 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • 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 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 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 SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 4YI0729529
    A synthetic oil made from plant-derived hydrocarbons that has been chemically saturated. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and improve tablet handling.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII VLW429K27K
    A synthetic oily liquid made from neopentyl glycol and medium-chain fatty acids. Used in medicines as an emollient and solubilizer to help dissolve active ingredients and improve how the body absorbs them.
  • 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 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • 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 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.

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

The official label also statesInactive Ingredients Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, 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

LabelerEbanel Laboratories, Inc
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code72654
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Ebanel Laboratories, Inc labeler code 72654

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses ■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation. ■ For the temporary relief of pain, burning and soreness.

⏱️ Dosage and Administration 57 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. Children under 12 years of age: consult a doctor. ■ Apply externally to the affected area up to 6 times daily.

⚠️ Warnings 97 words ▾

Warnings (For external use only) ■ If 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. ■ Do not put this product into the rectum by using fingers or any mechanical device or applicator. ■ Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

🧪 Active Ingredient 7 words ▾

Active Ingredient Purpose Lidocaine 5% ………………………………………….Local Anesthetic

🧪 Inactive Ingredients 30 words ▾

Inactive Ingredients Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine, Water

🎯 Purpose 2 words ▾

Purpose………………………………………….Local Anesthetic

📄 Keep Out of Reach of Children 56 words ▾

Other Information ■ Keep away from direct sunlight or heat. ■ Store at room temperature 15°-30°C (59°-86°F). ■ This package is child-resistant. Keep out of reach of children. ■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately. ■ Do not use this product if seal is broken or missing.

📄 Package Label / Principal Display Panel 14 words ▾

NUMB25 5% LIDOCAINE CHILD-RESISTANT PACKAGING Topical Anorectal Cream 1.35 oz e 38g Numb 25

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Numb25 (this brand).

Top reported reactions

Pain3,192
Nausea3,060
Fatigue3,051
Headache2,823
Dyspnoea2,175
Pneumonia2,006
Diarrhoea1,974

Reporter sex

49,061 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,656
Death4,990
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,428 2,258
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ebanel Laboratories, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ebanel Laboratories, 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.
← 72654-0033-02 · Ebanel 72654-0036-02 · Ebanel →
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.