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Pain Relief Gel-Roll On Menthol 40 g/L; 10 g/L Gel, 3 bottles — NDC 69396-0185-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pain Relief Gel-Roll On Menthol 40 g/L; 10 g/L Gel, 3 bottles — NDC 69396-185-03 (Billing 69396-0185-03)

by Trifecta Pharmaceuticals USA · 3 BOTTLE in 1 BOX / .073 L in 1 BOTTLE

This is a package of 3 bottles of Pain Relief Gel-Roll On Menthol 40 g/L; 10 g/L Gel from Trifecta Pharmaceuticals USA, marketed since Apr 2026 and currently FDA-listed.

NDC 69396-0185-03
🏷️ FDA NDC (as labeled) 69396-185-03 billing pads the product segment with a zero
This package
Contains3 bottles Pack sizes2 compare ↓
Product page 69396-0185-01 Also comes in: 1 bottle 69396-185-01
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 69396-185-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69396 labeler · 185 product · 03 package
Package marketed since
Apr 30, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850058161525, 0850058161518
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
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) 69396-185-03
Product NDC 69396-185
11-digit billing NDC 69396018503
RxCUI 1804176
UNII 98PI200987, L7T10EIP3A
UPC 0850058161525, 0850058161518
Application # M017
SPL Set ID 51b403dc-fc9b-0cad-e063-6394a90af081
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; MENTHOL
Quick answers
  • RxCUI (RxNorm): 1804176
Why two NDCs? The FDA registers this code as 69396-185-03 — 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 → 69396-0185-03. 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
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 Read our full Menthol 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69396-0185-01 69396-185-01 Main listing 1 BOTTLE in 1 BOX / .073 L in 1 BOTTLE 2026-04-30 — Active
69396-0185-03 You're viewing this 3 BOTTLE in 1 BOX / .073 L in 1 BOTTLE 2026-04-30 — Active

Pack size FAQ

What quantity is in this package?
This package contains 3 bottles — 3 bottle in 1 box / .073 l in 1 bottle.
How does this package differ from NDC 69396-0185-01?
Both are Pain Relief Gel-Roll On Menthol 40 g/L; 10 g/L Gel — the drug itself is identical. This page's package is the 3 bottles one, while NDC 69396-0185-01 is the 1 bottle package.
What NDC number is used to bill for this package of Pain Relief Gel-Roll On Menthol 40 g/L; 10 g/L 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/Lthis 69396-0185-03 Trifecta 3 bottles — — 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/mL 84165-0003-01 Guangzhou 1 bottle — — 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

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

🧪 Avoiding an ingredient? See Menthol 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 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 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 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 statesAloe Vera Extract, Carbomer, Isopropyl Myristate, Lavender oil, Phenoxyethanol, Polysorbate 80, Propylene glycol, Tartaric Acid, Vitamin E, 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

LabelerTrifecta Pharmaceuticals USA
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from Trifecta Pharmaceuticals USA labeler code 69396

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Indications and use Temporarily relieves minor pain.

⏱️ Dosage and Administration 36 words ▾

Directions Adults and children over 12 years: apply to the affected area not more than 3 to 4 times daily. Children 12 years or younger: ask a doctor After applying wash hands with soap and water

⚠️ Warnings 13 words ▾

Warnings For external use only. Flammable Keep away from excessive heat or flame.

📦 Storage and Handling 10 words ▾

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

🧪 Active Ingredient 8 words ▾

Active Ingredient Lidocaine 4%

Active Ingredient Menthol 1%

🧪 Inactive Ingredients 20 words ▾

Inactive Ingredient: Aloe Vera Extract, Carbomer, Isopropyl Myristate, Lavender oil, Phenoxyethanol, Polysorbate 80, Propylene glycol, Tartaric Acid, Vitamin E, Water

🎯 Purpose 6 words ▾

Purpose Topical Analgesic

Purpose Topical Analgesic

📄 Stop Use and Ask a Doctor If 56 words ▾

Stop Use and Ask Doctor if Stop use and ask doctor if Condition worsens severe burning sensation, redness, rash or irritation deveolps symptoms persisit 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 15 words ▾

If Pregnant or breast feeding If Pregnant or breast feeding as a doctor before use.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of Reach of Children If Swallowed, get medical help or contact a Poison Control Center right away

📄 Questions or Comments 3 words ▾

Questions? Call 1-888-296-9067

📄 Package Label / Principal Display Panel 19 words ▾

4092-FBA Globe Fast-Acting Pain Relief Gel Roll On 2

Label 409203 4 percent Lidocaine 1 percent Menthol roll-on 3PK

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
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 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 (69396-0185-01). 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.
← 69396-0184-01 · Trifecta 69396-0186-01 · Trifecta →
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.