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Salonpas Arthritis Pain Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch, 15 patches — NDC 46581-0680-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Salonpas Arthritis Pain Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch, 15 patches — NDC 46581-680-15 (Billing 46581-0680-15)

by Hisamitsu Pharmaceutical Co., Inc. · 3 POUCH in 1 BOX / 5 PATCH in 1 POUCH

This is a package of 15 patches of Salonpas Arthritis Pain Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch from Hisamitsu Pharmaceutical Co., Inc., marketed since Apr 2008 and currently FDA-listed.

NDC 46581-0680-15
🏷️ FDA NDC (as labeled) 46581-680-15 billing pads the product segment with a zero
This package
Contains15 patches Pack sizes6 compare ↓
Product page 46581-0680-01 Also comes in: 1 patch 46581-680-01 1 patch 46581-680-99 3 patches 46581-680-03 5 patches 46581-680-05 20 patches 46581-680-20
OTC Brand 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46581-680-15
Product NDC 46581-680
11-digit billing NDC 46581068015
RxCUI 853146
UNII L7T10EIP3A, LAV5U5022Y
Application # NDA022029
SPL Set ID 2e88c933-89e6-4a48-be7a-dc6a36e5c8f8
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-04-25
Route PERCUTANEOUS, TOPICAL, TRANSDERMAL
Dosage form PATCH
Substance MENTHOL; METHYL SALICYLATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 064937
GCN 18333
HICL code 002583
Ingredient (HICL) Methyl Salicylate/Menthol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 28:08.04.24
AHFS class Salicylates
FDB label name SALONPAS PATCH
FDB brand name Salonpas
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 064937
  • GCN: 18333
  • HICL (First Databank): 002583
  • AHFS class code: 28:08.04.24
  • RxCUI (RxNorm): 853146
Why two NDCs? The FDA registers this code as 46581-680-15 — 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 → 46581-0680-15. 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.

Clinical

Label name SALONPAS PATCH Ingredient Methyl Salicylate/Menthol
📗 Our plain-language guide HelloPharmacist
  • It is used on the skin for short-term relief of minor muscle and joint aches. That includes arthritis, backache, strains, sprains and bruises. Some products, like Diclofenac Sodium...
  • Apply it only to clean, intact skin, and follow your product's directions on how often. Wash your hands after using creams or handling patches, and keep it away from your eyes. Don...
  • A short burning feeling, redness or mild irritation where you apply it is the most common. It usually fades in several days. Stop and call your doctor if you get severe burning, bl...
  • Be careful. Methyl salicylate is a salicylate, related to aspirin, and labels say to talk to a doctor first if you are prone to allergic reactions to aspirin or salicylates. Some l...
📖 Read our full Menthol / Methyl Salicylate 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 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.
Try another pack size: 1 patch 1 patch 3 patches 5 patches 20 patches
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
46581-0680-01 46581-680-01 Main listing 1 PATCH in 1 POUCH 2008-05-01 — Active
46581-0680-03 46581-680-03 3 PATCH in 1 POUCH 2008-09-01 — Active
46581-0680-05 46581-680-05 1 POUCH in 1 BOX / 5 PATCH in 1 POUCH 2008-05-01 — Active
46581-0680-15 You're viewing this 3 POUCH in 1 BOX / 5 PATCH in 1 POUCH 2008-06-01 — Active
46581-0680-20 46581-680-20 4 POUCH in 1 BOX / 5 PATCH in 1 POUCH 2022-11-01 — Active
46581-0680-99 46581-680-99 1 PATCH in 1 POUCH 2008-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 15 patches — 3 pouch in 1 box / 5 patch in 1 pouch.
How does this package differ from NDC 46581-0680-01?
Both are Salonpas Arthritis Pain Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch — the drug itself is identical. This page's package is the 15 patches one, while NDC 46581-0680-01 is the 1 patch package.
What NDC number is used to bill for this package of Salonpas Arthritis Pain Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch?
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
Salonpas Pain Relief 31.5 mg/1; 105 mg 46581-0670-01 Hisamitsu 1 patch — — FDA listed —
Salonpas Pain Relief 63 mg/1; 210 mg 46581-0675-01 Hisamitsu 1 patch — — FDA listed —
Salonpas Arthritis Pain 31.5 mg/1; 105 mgthis 46581-0680-15 Hisamitsu 15 patches — — FDA listed —
Salonpas Arthritis Pain 63 mg/1; 210 mg 46581-0685-09 Hisamitsu 9 patches — — FDA listed —
HealthWise Pain Relief Patch 3 g/100g; 10 g/100g 71101-0106-01 Veridian 40 patches — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2008
First FDA approval
Feb 2008
📍
2026
Currently FDA-listed
18 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 20, 2008 RLD RS ⏳ ~3.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9233184 — drug product
US 8809615 — drug product
US 9233184 — drug product
US 8809615 — drug product
2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 9233184 ↗ Drug product — Aug 1, 2027
US 8809615 ↗ Drug product — Jan 3, 2030
US 9233184 ↗ Drug product — Aug 1, 2027
US 8809615 ↗ Drug product — Jan 3, 2030
Common questions
Is there a generic version of SALONPAS PATCH?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SALONPAS PATCH. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2030 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerHisamitsu Pharmaceutical Co., Inc.
Application holderHISAMITSU PHARMACEUTICAL CO INC
FDA applicationNDA022029 (NDA)
Labeler code46581
First marketedApr 2008
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.

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 21 words ▾

Uses Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: arthritis sprains strains bruises simple backache

⏱️ Dosage and Administration 123 words ▾

Directions Adults 18 years and older: only use one patch at a time clean and dry affected area remove patch from backing film and apply to skin (see illustration) apply one patch to the affected area and leave in place for up to 8 to 12 hours if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours do not use more than 2 patches per day do not use for more than 3 days in a row the used patch should be removed from the skin when a new one is applied Children under 18 years of age: do not use; this product has not been shown to work in children

⚠️ Warnings ~2 min read ▾

Warnings For external use only Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use on the face or rashes on wouds or damaged skin if allergic to aspirin or other NSAIDs with a heating pad when sweating (such as from exercise or heat) any patch from a pouch that has been open for 14 or more days right before or after heart surgery Ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease, or kidney disease When using this product wash hands after applying or removing patch.

Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away.

Package not child resistant. Dispose of the used patches after folding sticky ends together.

📦 Storage and Handling 37 words ▾

Other information store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit) avoid storing product in direct sunlight protect product from excessive moisture some individuals may not experience pain relief until several hours after applying the patch

🧪 Active Ingredient 15 words ▾

Active ingredients (in each patch) Menthol 3% Methyl salicylate 10% (NSAID : nonsteroidal anti-inflammatory drug)

🧪 Inactive Ingredients 20 words ▾

Inactive inredients alicyclic saturated hydrocarbon resin, baking cloth, film, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-sryrene block copolymer, synthetic aluminum silicate

🎯 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 ↗

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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

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 Hisamitsu Pharmaceutical Co., Inc.. 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 5 other package presentations of this same product, including 1 patch (46581-0680-01), 1 patch (46581-0680-99), 3 patches (46581-0680-03). 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?
Hisamitsu Pharmaceutical Co., 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.
← 46581-0675-01 · Hisamitsu 46581-0685-09 · Hisamitsu →
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.