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Pure-Aid Lidocaine, Menthol 240 mg; 60 mg Patch, 1 patch — NDC 67510-0284-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pure-Aid Lidocaine, Menthol 240 mg; 60 mg Patch, 1 patch — NDC 67510-0284-1 (Billing 67510-0284-01)

by Kareway Product, Inc. · 1 PATCH in 1 POUCH

This is a package of 1 patch of Pure-Aid Lidocaine, Menthol 240 mg; 60 mg Patch from Kareway Product, Inc., marketed since Mar 2018 and currently FDA-listed. It is this product's only package size.

NDC 67510-0284-01
🏷️ FDA NDC (as labeled) 67510-0284-1 billing pads the package 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 67510-0284-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67510 labeler · 0284 product · 1 package
Package marketed since
Mar 2, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6751002841 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67510-0284-1
Product NDC 67510-0284
11-digit billing NDC 67510028401
RxCUI 1249758
UNII 98PI200987, L7T10EIP3A
Application # part348
SPL Set ID 6679cada-f083-26e8-e053-2a91aa0adcc5
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-02
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 1249758
Why two NDCs? The FDA registers this code as 67510-0284-1 — a 5-4-1 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 package segment → 67510-0284-01. 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

🧪 What is this product?

Pure-Aid Lidocaine, Menthol is a topical patch containing the local anesthetic lidocaine and the counterirritant menthol. This over-the-counter monograph product is typically used to numb or soothe localized skin discomfort when applied directly to the affected area. Lidocaine works by blocking nerve signals in the skin, while menthol produces a cooling sensation that may help mask minor aches and pains.

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 eachPer 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
67510-0284-01 You're viewing this Main listing 1 PATCH in 1 POUCH 2018-03-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Menthol Pain Relief 4 g/100g; 1 g/100g 46122-0574-21 Amerisource 5 patches $0.952 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 70000-0558-01 Cardinal 5 patches $0.952 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 00363-0914-05 Walgreen 5 patches — — FDA listed —
Walgreens Cool N Heat Patch 10 mg/g; 40 mg/g 00363-6670-05 Walgreen 5 patches — — FDA listed —
Walgreens Kinesiology Pain Relief 4 mg/100mg; 1 mg/100mg 00363-9657-00 Walgreen 20 applicators — — FDA listed —
Maximum Strenght Lidocaine plus Menthol Pain Relief Patch 1 g/100g; 4 g/100g 11822-6514-01 Rite 5 patches — — FDA listed —
Albertson Lidocaine, Menthol Pain Relief Medicated Patch 4 g/100g; 1 g/100g 21130-0961-05 Safeway 5 g — — FDA listed —
Icy Hot with Lidocaine 240 mg/1; 60 mg 41167-1720-01 Chattem, 5 patches — — FDA listed —
Maximun Strength Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 41250-0841-05 Meijer 5 patches — — FDA listed —
CVS Cold and Hot Pain Relief 10 mg/g; 40 mg/g 51316-0274-05 CVS 5 patches — — FDA listed —
Lidospot patch .01 g/g; .04 g/g 51452-0172-05 Fabrication 5 patches — — FDA listed —
Point Relief LidoSpot with Menthol 4 g/100g; 1 g/100g 51452-0912-05 Fabrication 5 patches — — FDA listed —
MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100g 55301-0912-05 ARMY 5 patches — — FDA listed —
Biofreeze Ultraflex Plus .04 g/g; .01 g/g 59316-0898-04 Reckitt 4 patches — — FDA listed —
CVS Health Lidocaine Pain Relief Plus Menthol 240 mg/1; 60 mg 66902-0220-05 Natural 5 patches — — FDA listed —
Pure-Aid 240 mg/1; 60 mgthis 67510-0284-01 Kareway 1 patch — — FDA listed —
Soundbody 40 mg/1; 10 mg 67510-0636-01 Kareway 1 patch — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 68788-8879-01 Preferred 15 mg — — FDA listed —
Lidocaine Pain Relief Patch 1 g/100g; 4 g/100g 69159-0920-05 Foshan 5 patches — — FDA listed —
HealthWise Lidocaine Plus Menthol Patch 4 g/100g; 1 g/100g 71101-0062-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol 4 g/100g; 1 g/100g 71101-0082-15 Veridian 15 g — — FDA listed —
TheraCare 2X Medicated Pain Relief 1 g/100g; 4 g/100g 71101-0127-01 Veridian 5 patches — — FDA listed —
TheraCare Pain Relief Medicated 4 g/100g; 1 g/100g 71101-0912-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol Pain Relief 4 g/100g; 1 g/100g 71101-0914-05 Veridian 5 g — — FDA listed —
Lidozen 40 mg/g; 10 mg/g 71205-0348-05 Proficient 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71205-0745-05 Proficient 5 patches — — FDA listed —
Dr Sabharwals 224 mg/1; 56 mg 71318-0115-15 Dr. 15 patches — — FDA listed —
AsperFlex MAX 240 mg/1; 60 mg 71399-4453-05 Akron 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71574-0905-05 Village 5 patches — — FDA listed —
Hot and Cold Lidocaine with Menthol Patch Pain Relief 240 mg/1; 60 mg 71811-0002-05 InterMed 500 patches — — FDA listed —
Lidothol Patch 1 mg/100mg; 4 mg/100mg 72189-0553-15 Direct_Rx 1 patch — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0172-05 Shanghai 5 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0174-20 Shanghai 20 patches — — FDA listed —
Pain Relief .01 g/g; .04 g/g 73557-0175-20 Shanghai 20 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0176-18 Shanghai 18 patches — — FDA listed —
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee 40 mg/g; 10 mg/g 75568-0013-01 Planet 4.56 g — — FDA listed —
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border 40 mg/g; 10 mg/g 75568-0014-01 Planet 9.1 g — — FDA listed —
Careland Plantar Fasciitis Hydrogel Pain Patches 40 mg/g; 10 mg/g 75568-0017-01 Planet 8 pouches — — FDA listed —
Careland Hydrogel Pain Relief Patches 40 mg/g; 10 mg/g 75568-0022-01 Planet 8 patches — — FDA listed —
TopCare Pain Relief Patch 4 g/100g; 1 g/100g 76162-0007-05 Topco 5 pouches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 76420-0581-15 Asclemed 15 patches — — FDA listed —
Equate Lidocaine and Menthol Paraben Free 1 g/100g; 4 g/100g 79903-0030-05 Walmart 5 pouches — — FDA listed —
Equate Lidocaine Cool and Heat 1 g/100g; 4 g/100g 79903-0038-05 Walmart 5 pouches — — FDA listed —
Lidothol 1 mg/100mg; 4 mg/100mg 80425-0385-01 Advanced 15 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 80425-0506-01 Advanced 15 mg — — FDA listed —
Lidocaine and Menthol .04 g/g; .01 g/g 80425-0560-01 Advanced 30 patches — — FDA listed —
LidoPro .04 g/g; .01 g/g 80425-0582-01 Advanced 30 patches — — FDA listed —
LidoReal Patch 4 mg/1; 1 mg 81877-0725-15 FORREAL 15 patches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 81902-0104-15 Whitestone 15 patches — — FDA listed —
Lidosync 4 g/1; 1 g 82944-0104-10 Ion 10 patches — — FDA listed —
Pain Relief Gel-Patch .12 g/12g; .48 g/12g 83016-0171-07 R 7 packets — — FDA listed —
AUVON Lidocaine Menthol Pain Relief Patch 100 mg/1; 400 mg 83391-0008-01 SHENZHEN 1 patch — — FDA listed —
Collajoint Lidocaine Pain Relief Gel Patch 1 g/1001; 4 g/1001 83559-0012-01 Henan 12 patches — — FDA listed —
Rapid Relief 1 g/100g; 4 g/100g 83569-0014-01 RAPID 100 g — — FDA listed —
Rapid Relief 4 g/100g; 1 g/100g 83569-0016-06 RAPID 1 pouch — — FDA listed —
Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0172-15 Guangzhou 15 patches — — FDA listed —
Foot Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0174-15 Guangzhou 15 patches — — FDA listed —
Lidocaine Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0175-11 Guangzhou 11 patches — — FDA listed —
Knee Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0178-12 Guangzhou 12 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 83881-0402-05 Clinic 5 mg — — FDA listed —
LidoPro .04 g/g; .01 g/g 83881-0403-01 Clinic 1 patch — — FDA listed —
Lidothol 4 mg/100mg; 1 mg/100mg 83881-0441-15 Clinic 15 patches — — Discontinued —
Plantar Fasciitis Pain Relief Gel-Patch 1 g/100g; 4 g/100g 84165-0007-01 Guangzhou 6 g — — FDA listed —
Chinese Red Tiger Lidocaine Patches .04 g/g; .01 g/g 84165-0010-01 Guangzhou 12 g — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 84165-0104-01 Guangzhou 12 g — — FDA listed —
Perform Leo Extensive Pain Relief 4 g/100g; 1 g/100g 84410-0001-01 PERFORM 5 patches — — FDA listed —
Lidocaine .4 g/10g; .1 g/10g 84722-3041-00 Vive 5 g — — FDA listed —
Lidocaine .1 g/10g; .4 g/10g 84722-3072-00 Vive 5 g — — FDA listed —
4% lidocaine plus 1% menthol Pain Relief Patch 1 g/100g; 4 g/100g 85323-0003-00 Xuzhou 5 patches — — FDA listed —
4% Lidocaine Patches 4 g/100g; 1 g/100g 85593-0010-01 Guangzhou 15 patches — — Discontinued —
NeuroCool Patches 4 mg/100mg; 1 mg/100mg 85622-0500-15 Blue 15 pouches — — FDA listed —
Plantar Pain Relief Patch .01 g/g; .04 g/g 87518-0174-15 Guangzhou 15 patches — — FDA listed —
Icy Hot 240 mg/1; 60 mg 62168-1720-01 Lead 400 patches — — 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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 DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • UNII 3L7GR2604E
    A synthetic compound derived from glycerol and formaldehyde, used as a solvent and humectant in liquid formulations to help dissolve active ingredients and maintain moisture content in the product.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 9G2MAD7J6W
    Polyacrylic acid is a synthetic polymer used as a binder and thickening agent in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid or semi-solid 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesdihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, 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

LabelerKareway Product, Inc.
FDA applicationpart348 (OTC MONOGRAPH NOT FINAL)
Labeler code67510
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Kareway Product, Inc. labeler code 67510

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Uses Temporarily relieves minor pain

⏱️ Dosage and Administration 80 words ▾

Directions adults and children over 12 years: clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 2 patch for up to 24 hours children 12 years or younger: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 6 words ▾

Active ingredient Lidocaine 4% Menthol 1%

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

🎯 Purpose 5 words ▾

Purposes Topical Anesthetic Topical Analgesic

📄 Do Not Use 32 words ▾

Do Not Use more than 1 patch on your body at a time or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor

📄 When Using This Product 118 words ▾

When Using This Product use only as directed. Read and follow all directions and warnings on this label. rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not allow contact with the eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets.

Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

📄 Stop Use and Ask a Doctor If 48 words ▾

Stop Use and Ask a Doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

🤰 If Pregnant or Breast-Feeding 10 words ▾

If Pregnant or Breast-Feeding ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep Out of Reach of Children and Pets If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 55 words ▾

Package/Label Principal Display Panel Pure-Aid MAXIMUM STRENGTH LIDOCAINE PATCH PLUS MENTHOL Targeted Immediate Pain Relief Desensitizes Aggravated Nerves Dual Action with Lidocaine and Menthol Fast Acting and Long Lasting First Aid for Pain Pain Relieving Ointment on a Breathable Adhesive Pad Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm) each Label pouch

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 Lidocaine, Menthol — the ingredient across all brands.

Top reported reactions

Pain3,217
Fatigue3,056
Nausea3,046
Headache2,815
Dyspnoea2,181
Pneumonia2,007
Diarrhoea1,981

Age at onset

Neonate144
Infant62
Child366
Adolescent259
Adult4,987
Elderly3,158

Reporter sex

49,320 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,575
Death4,981
Life-threatening4,202
Disabling1,205
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,427 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.

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 Not Final". 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 Kareway Product, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kareway Product, 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.
← 67509-0008-50 · Noramco 67510-0289-01 · Kareway →
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.