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Lidocaine Pain Relief Gel Roll-On .01 g/mL; .04 g/mL Gel — NDC 84165-0003-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocaine Pain Relief Gel Roll-On .01 g/mL; .04 g/mL Gel — NDC 84165-003-10 (Billing 84165-0003-10)

by Guangzhou Zhupuyou E-commerce Co., Ltd · 10 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE

This is a package of Lidocaine Pain Relief Gel Roll-On .01 g/mL; .04 g/mL Gel from Guangzhou Zhupuyou E-commerce Co., Ltd, marketed since Mar 2025 and currently FDA-listed.

NDC 84165-0003-10
🏷️ FDA NDC (as labeled) 84165-003-10 billing pads the product segment with a zero
This package
Contains73 mL in 1 bottle Pack sizes10 compare ↓
Product page 84165-0003-01 Also comes in: 73 mL 84165-003-01 2 bottles 84165-003-02 3 bottles 84165-003-03 4 bottles 84165-003-04 5 bottles 84165-003-05 6 bottles 84165-003-06 7 bottles 84165-003-07 8 bottles 84165-003-08 9 bottles 84165-003-09
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 84165-003-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84165 labeler · 003 product · 10 package
Package marketed since
Mar 28, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8416500310 7
FDA record last changed
Aug 27, 2026
⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84165-003-10
Product NDC 84165-003
11-digit billing NDC 84165000310
RxCUI 1804176
UNII L7T10EIP3A, 98PI200987
Application # M017
SPL Set ID 31639407-0f11-bde2-e063-6294a90af694
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 2025-03-28
Route TOPICAL
Dosage form GEL
Substance MENTHOL; LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1804176
Why two NDCs? The FDA registers this code as 84165-003-10 — 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 → 84165-0003-10. 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: 73 mL 2 bottles 3 bottles 4 bottles 5 bottles 6 bottles 7 bottles 8 bottles 9 bottles
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
84165-0003-01 84165-003-01 Main listing 1 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-02 84165-003-02 2 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-03 84165-003-03 3 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-04 84165-003-04 4 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-05 84165-003-05 5 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-06 84165-003-06 6 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-07 84165-003-07 7 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-08 84165-003-08 8 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-09 84165-003-09 9 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active
84165-0003-10 You're viewing this 10 BOTTLE in 1 BOX / 73 mL in 1 BOTTLE 2025-03-28 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 bottle in 1 box / 73 ml in 1 bottle.
What NDC number is used to bill for this package of Lidocaine Pain Relief Gel Roll-On .01 g/mL; .04 g/mL Gel?
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
Pain Relief Gel-Roll On 40 g/L; 10 g/L 69396-0185-01 Trifecta 1 bottle — — FDA listed —
HealthWise Roll-On 1 g/100g; 4 g/100g 71101-0110-01 Veridian 73 g — — FDA listed —
PAIN RELIEF Gel-Roll On .04 g/mL; .01 g/mL 73557-0373-25 Shanghai 73 ml — — FDA listed —
Heel Pain Relief Roll-On .04 g/mL; .01 g/mL 83602-0373-73 Guangzhou 1 bottle — — FDA listed —
Hip Pain Relief Roll-On .04 g/mL; .01 g/mL 83602-0773-73 Guangzhou 1 bottle — — FDA listed —
Pain Relief Gel-Roll On .04 g/mL; .01 g/mL 84008-0002-02 Bullet 1 bottle — — FDA listed —
Lidocaine Pain Relief Gel Roll-On .01 g/mL; .04 g/mLthis 84165-0003-10 Guangzhou 10 bottles — — FDA listed —
Sumifun PLANTAR RELIEF ROLL -ON 1 g/100mL; 4 g/100mL 84165-0015-01 Guangzhou 1 bottle — — FDA listed —
Tidl Pain Relief Heat Therapy Roll-On 1 g/100g; 4 g/100g 84214-0002-01 Shenzhen 85 g — — 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
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII N9PR3490H9
    A naturally derived form of vitamin E that acts as an antioxidant in medicines. It prevents oils and fats in the product from breaking down or becoming rancid during storage.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical 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 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 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 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 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.

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

The official label also states.ALPHA.-TOCOPHEROL, D- Aloe Vera Extract Carbomer Isopropyl myristate Lavender Oil Phenoxyethanol Polysorbate 80 Propylene Glycol Tartaric acid 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

LabelerGuangzhou Zhupuyou E-commerce Co., Ltd
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code84165
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio21 products on file

More NDCs from Guangzhou Zhupuyou E-commerce Co., Ltd labeler code 84165

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Temporarily relieves muscle soreness and minorjoin pains in the wrist,knees, back, neck, hips,shoulders,elbows.

⏱️ Dosage and Administration 51 words ▾

Adults and Children above 12 years old: apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily massage until thoroughly absorbed into skin wash hands thoroughly with soap and waterafter each use children under 12 years of age: ask a doctor

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 4 words ▾

Lidocaine 4% Menthol 1%

🧪 Inactive Ingredients 18 words ▾

.ALPHA.-TOCOPHEROL, D- Aloe Vera Extract Carbomer Isopropyl myristate Lavender Oil Phenoxyethanol Polysorbate 80 Propylene Glycol Tartaric acid Water

🎯 Purpose 4 words ▾

Topical Anesthetic, Topical Analgesic

📄 Do Not Use 29 words ▾

on wounds or on irritated or damaged skin with a heating pad or device with other ointments,creams, sprays, orliniments if your are allergic to any ingredients of this product

📄 When Using This Product 28 words ▾

use only as directed avoid contact with the eyes, mucous membranes,or rashes do not bandage tightly do not expose the area to local heat or to direct sunlight

📄 Stop Use and Ask a Doctor If 36 words ▾

skin reactions such as redness,swelling blistering or other discomfort occur condition worsens or symptoms persist formore than 7 days symptoms clear up and occur again within afew days redness is present or excessive skin irritation occurs

📄 Keep Out of Reach of Children 12 words ▾

lf swallowed accidentally ,get medical help orcontact with Poison Control Center immediately.

📄 Package Label / Principal Display Panel 1 words ▾

label1

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lidocaine. CMS lists 8 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Pain Relief Gel Roll-On (this brand).

Top reported reactions

Pain3,167
Fatigue3,038
Nausea3,029
Headache2,802
Dyspnoea2,166
Pneumonia2,001
Diarrhoea1,966

Age at onset

Neonate144
Infant62
Child363
Adolescent258
Adult4,906
Elderly3,132

Reporter sex

48,643 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,523
Life-threatening4,195
Disabling1,187
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 3,951 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 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 Guangzhou Zhupuyou E-commerce Co., Ltd. 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 9 other package presentations of this same product, including 1 bottle (84165-0003-01), 2 bottles (84165-0003-02), 3 bottles (84165-0003-03). 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?
Guangzhou Zhupuyou E-commerce Co., Ltd 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.
← 84165-0002-01 · Guangzhou 84165-0004-01 · Guangzhou →
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.