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Pain Relief Gel-Roll On Lidocaine 40 g/L Gel, 2 bottles — NDC 69396-0188-02 package photo

Pain Relief Gel-Roll On Lidocaine 40 g/L Gel, 2 bottles

by Trifecta Pharmaceuticals USA · 2 BOTTLE in 1 BOX (69396-188-02) / .073 L in 1 BOTTLE
NDC 69396-0188-02
🏷️ FDA NDC (as labeled) 69396-188-02 billing pads the product segment with a zero
This package
Contains2 bottles Pack sizes2 compare ↓
Also comes in: 1 bottle 69396-0188-01
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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

FDA NDC (as labeled) 69396-188-02
Product NDC 69396-188
11-digit billing NDC 69396018802
RxCUI 1010077
UNII V13007Z41A
UPC 0850058161402, 0850058161556
Application # M017
SPL Set ID 51cb6797-55ec-7a7a-e063-6294a90a90ee
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 2026-04-27
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 69396-188-02 — 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 → 69396-0188-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTrifecta Pharmaceuticals USA
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio11 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied 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.

🧪 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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • 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 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 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.

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

The official label also statesAloe Vera Extract, Carbomer, Isopropyl Myristate, Polysorbate 80, Propylene glycol, Vitamin E, Water, 1,2 Hexanediol, Aminomethylpropanol, Butylene Glycol, Cetostearyl alcohol, Dimethicone, Edetate Disodium, Glycerin, Glycerol Mono and Dipalmitostearate, hydroxyacetophenone

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 bottle
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Burn 4 g/100g 00363-2020-25 WALGREENS 1 tube — — FDA listed —
Walgreens Cool n Heat Lidocaine 4 g/100g 00363-7801-02 Walgreens 71 g — — FDA listed —
Roll-On Pain Relief Liquid 4 g/100g 42507-0916-01 HyVee 73 g — — FDA listed —
Alocane Emergency Burn 4 g/100mL 68229-0201-02 Quest 1 tube — — FDA listed —
SunBurnt PLUS 4 g/100mL 68229-0600-01 Quest 1 tube — — Discontinued —
SunBurnt PLUS 4 g/100mL 68229-0601-02 Quest 1 tube — — FDA listed —
Pain Relief Gel-Roll On 40 g/Lthis 69396-0188-02 Trifecta 2 bottles — — FDA listed —
CVS Maximum Strength Burn 4 g/100g 69842-0309-25 CVS 1 tube — — FDA listed —
Derma Numb Pain Relief 40 mg/g 70188-0005-01 A.T.S. 28 g — — FDA listed —
DermaNumb Analgesic 40 mg/g 70188-0006-01 A.T.S. 57 g — — FDA listed —
Lidovyx 40 mg/g 72835-0447-01 V2 70 g — — FDA listed —
DCH Pain Relief Roll-On 4 g/100g 72839-0087-02 Derma 1 bottle — — FDA listed —
Warrior Pain Relief Roll-On Maximum Strength 4 g/100g 72839-0108-02 Derma 71 g — — FDA listed —
Warrior Burn Relief Aloe Maximum Strength 4 g/100mL 72839-0185-04 Derma 118 ml — — FDA listed —
Relief Gel 4 g/100mL 73716-0003-05 Good 5 ml — — FDA listed —
Mirakel Pain Relief Roll-On 4 g/100g 78589-0257-03 Sanvio, 85 g — — FDA listed —
Meijer Pain Relief 4 g/100g 79481-1087-02 Meijer 71 g — — FDA listed —
Burn Relief Aloe 4 g/100g 80551-0001-03 Acutens 113 g — — FDA listed —
Pomg Night Time Pain Relief Roller 40 mg/mL 84615-0007-02 POMG 1 bottle — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

📊 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 PAIN RELIEF Gel-Roll On (this brand).

Top reported reactions

Pain3,233
Fatigue3,094
Nausea3,067
Headache2,846
Dyspnoea2,233
Pneumonia2,041
Diarrhoea2,004

Age at onset

Neonate144
Infant62
Child364
Adolescent259
Adult4,984
Elderly3,215

Reporter sex

49,524 reports

Serious outcomes

Death5,052
Life-threatening4,239
Disabling1,212
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 4,193 2,317
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69396-0188-01 1 BOTTLE in 1 BOX (69396-188-01) / .073 L in 1 BOTTLE 2026-04-30 Active
69396-0188-02 You're viewing this 2 BOTTLE in 1 BOX (69396-188-02) / .073 L in 1 BOTTLE 2026-04-30 Active

Pack size FAQ

What quantity is in NDC 69396-0188-02?
NDC 69396-0188-02 contains 2 bottles — 2 bottle in 1 box / .073 l in 1 bottle.
What is the difference between NDC 69396-0188-02 and NDC 69396-0188-01?
Both are Pain Relief Gel-Roll On Lidocaine 40 g/L Gel — the drug itself is identical. NDC 69396-0188-02 is the 2 bottles package, while NDC 69396-0188-01 is the 1 bottle package.
What NDC number is used to bill for this package of Pain Relief Gel-Roll On Lidocaine 40 g/L Gel?
Bill NDC 69396-0188-02 — the 11-digit billing format is 69396018802. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69396-188-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69396-0188-02, written without dashes as 69396018802. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69396-0188-02, the first segment (69396) is the labeler code FDA assigned to Trifecta Pharmaceuticals USA; the middle segment (0188) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Trifecta Pharmaceuticals USA. 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 1 other package presentation of this same product, including 1 bottle (69396-0188-01). 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?
Trifecta Pharmaceuticals USA is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 7 words ▾

Indications and use Temporarily relieves minor pain.

⏱️ Dosage and Administration 31 words ▾

Directions Adults and children over 12 years: apply a thin layer to the affected area not more than 3 to 4 times daily. Children 12 years or younger: ask a doctor

⚠️ Warnings 14 words ▾

Warning Section For External Use Only Flammable - keep away from fire or flames.

📦 Storage and Handling 10 words ▾

Other Information Store at 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 5 words ▾

Active Ingredient Lidocaine HCI 4%

🧪 Inactive Ingredients 31 words ▾

Inactive Ingredient: Aloe Vera Extract, Carbomer, Isopropyl Myristate, Polysorbate 80, Propylene glycol, Vitamin E, Water, 1,2 Hexanediol, Aminomethylpropanol, Butylene Glycol, Cetostearyl alcohol, Dimethicone, Edetate Disodium, Glycerin, Glycerol Mono and Dipalmitostearate, hydroxyacetophenone

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69396-0187-01 · Trifecta 69413-0330-10 · Vyera →
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.