Home › NDC Lookup › Ingredients › L-Menthol › 55264-0116-02
🩹image loading
(from DailyMed)

Sinsinpas Arex Flex Gel Pain Relieving Patch L-Menthol 57.6 mg; 96 mg; 76.8 mg Patch

by Sinsin Pharmaceutical Co., Ltd. · 1 PATCH in 1 POUCH (55264-116-02) / 6 PATCH in 1 PATCH (55264-116-01)
NDC 55264-0116-02
🏷️ FDA NDC (as labeled) 55264-116-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 55264-116-02
Product NDC 55264-116
11-digit billing NDC 55264011602
RxCUI 2568113
UNII LAV5U5022Y, 5TJD82A1ET, BZ1R15MTK7
Application # M017
SPL Set ID 1758ef9b-4fac-4066-e063-6394a90a8cc3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-01
Route TOPICAL
Dosage form PATCH
Substance METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL
Why two NDCs? The FDA registers this code as 55264-116-02 — 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 → 55264-0116-02. 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.

🏭 Manufacturer & labeler

LabelerSinsin Pharmaceutical Co., Ltd.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55264
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio12 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

🧪 What is this product?

Sinsinpas Arex Flex Gel Pain Relieving Patch is a topical patch product marketed as an over-the-counter monograph drug. It contains three active ingredients: camphor, levomenthol, and methyl salicylate, which are commonly used together in pain relief patches to produce a warming or cooling sensation on the skin and to help reduce discomfort in sore muscles and joints. The patch is designed to be applied directly to the skin over the affected area.

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.

🧪 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 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 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 S846B891OR
    Nonivamide is a synthetic compound similar to capsaicin, the active component in hot peppers. In medications, it is used as a rubefacient or counterirritant in topical formulations to create localized warming or tingling sensations.
  • 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 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesButylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution, Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sinsinpas Arex Flex Gel Pain Relieving Patch 57.6 mg/1; 96 mg/1; 76.8 mgthis 55264-0116-02 Sinsin 1 patch — — 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.

🔬 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 Sinsinpas Arex Flex Gel Pain Relieving Patch (this brand).

Top reported reactions

Back Pain1
Bacterial Infection1
Blood Creatinine Increased1
Constipation1
Death1
Deep Vein Thrombosis1
Erythema1

Age at onset

Elderly1

Reporter sex

8 reports
Male · 43%
Female · 57%

Serious outcomes

Hospitalization4
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55264-0116-02 You're viewing this 1 PATCH in 1 POUCH (55264-116-02) / 6 PATCH in 1 PATCH (55264-116-01) 2024-05-01 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 55264-116-02, 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: 55264-0116-02, written without dashes as 55264011602. 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 55264-0116-02, the first segment (55264) is the labeler code FDA assigned to Sinsin Pharmaceutical Co., Ltd.; the middle segment (0116) 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 Sinsin Pharmaceutical Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sinsin Pharmaceutical 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.

📄 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
🎯 Indications and Usage 21 words ▾

For the temporary relief of minor aches and pains of muscles and joints associated with: Arthritis Simple backache Strains Bruises Sprains

⏱️ Dosage and Administration 53 words ▾

Directions Adults and children 12 years of age and over: ■ clean and dry affected area ■ remove patch from film ■ apply to affected area not more than 3 times daily ■ remove patch from skin after at most 8 hours of application children under 12 years of age: Consult a doctor

⚠️ Warnings 109 words ▾

For external use only Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Do not use on wounds or damaged skin if you are allergic to any ingredients of this product with a heating pad When using this product use only as directed avoid contact with eyes, mucous membranes, and rashes Stop use and ask a doctor if skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur condition worsens symptoms persist for longer than 7 days symptoms clear up and reoccur within a few days If pregnant or breast-feeding , ask a health professional before use.

🧪 Active Ingredient 9 words ▾

Active Ingredients L-Menthol 76.8mg Methyl Salicylate 57.6mg DL-Camphor 96.0mg

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredients Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution, Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water

🎯 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 ↗
← 55264-0115-04 · Sinsin 55264-0117-02 · Sinsin →
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.