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Methyl Salicylate 100 mg/1000mg Patch

by PHARMACURE LLC · 2 POUCH in 1 BOX (79643-003-01) / 5 PATCH in 1 POUCH / 1000 mg in 1 PATCH
NDC 79643-0003-01
🏷️ FDA NDC (as labeled) 79643-003-01 billing pads the product segment with a zero
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

🆔 Identity & classification

FDA NDC (as labeled) 79643-003-01
Product NDC 79643-003
11-digit billing NDC 79643000301
NCPDP billing unit EA — each (per item)
RxCUI 1053397
UNII LAV5U5022Y
Application # M017
SPL Set ID 66b13044-69d2-4559-9e65-8a4c601c077a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-17
Route TOPICAL
Dosage form PATCH
Substance METHYL SALICYLATE
GCN Seq No 082330
GCN 49718
HICL code 002595
Ingredient (HICL) Methyl Salicylate
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 METHYL SALICYLATE 10% PATCH
FDB brand name Methyl Salicylate
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 79643-003-01 — 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 → 79643-0003-01. 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

LabelerPHARMACURE LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code79643
First marketedFeb 2023
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

Label name METHYL SALICYLATE 10% PATCH Ingredient Methyl Salicylate
📗 Our plain-language guide HelloPharmacist
  • It's a topical pain reliever — you apply it right to the skin where it hurts. It's used for temporary relief of minor aches and pains in your muscles and joints, things like arthri...
  • What is methyl salicylate actually used for?
  • No — and this is really important. You should never use methyl salicylate products with a heating pad, and avoid applying them when you're sweating from exercise or heat. Heat caus...
  • Is it safe to use under a heating pad or wrap?
📖 Read our full 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.

🧪 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 JC71GJ1F3L
    Myrrh is a natural resin obtained from a tree, traditionally used in medicines and perfumes. It may serve as a flavoring agent, fragrance, or mild preservative in formulations.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesAdhesive, myrrh gum, zinc oxide.

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
Methyl Salicylate 10 g/100g 50488-2010-01 Alexso, 10 patches — — FDA listed —
10% Methyl Salicylate Pain Relief Patch 10 mg/100mg 65604-0222-20 Akron 10 mg — — FDA listed —
Methyl Salicylate 100 mg/1000mgthis 79643-0003-01 PHARMACURE 10 patches — — FDA listed —
Methyl Salicylate 10 g/100g 82461-0414-10 Medcore 10 patches — — FDA listed —
Methyl Salicylate 10% 10 g 82944-0101-10 ION 50 patches — — FDA listed —
Methyl Salicylate 10 g/100g 84460-0103-01 Florrax 10 patches — — FDA listed —
Methyl Salicylate 10% 10 g/100g 85231-0101-15 ViolaCare, 15 patches — — 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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 Methyl salicylate — the ingredient across all brands.

Top reported reactions

Pain141
Application Site Pain124
Nausea118
Diarrhoea111
Pruritus96
Fatigue95
Dyspnoea94

Age at onset

Child9
Adolescent5
Adult146
Elderly114

Reporter sex

2,103 reports
Male · 33%
Female · 66%
Unknown · 1%

Serious outcomes

Hospitalization373
Death73
Disabling58
Life-threatening47
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 196 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
79643-0003-01 You're viewing this 2 POUCH in 1 BOX (79643-003-01) / 5 PATCH in 1 POUCH / 1000 mg in 1 PATCH 2023-02-17 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 79643-003-01, 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: 79643-0003-01, written without dashes as 79643000301. 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 79643-0003-01, the first segment (79643) is the labeler code FDA assigned to PHARMACURE LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 PHARMACURE LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PHARMACURE LLC 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
🎯 Indications and Usage 26 words ▾

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

⏱️ Dosage and Administration 130 words ▾

Directions Adults 18 years and older: • Clean and dry affected area • Only use one patch at a time • Remove patch from backing film and apply to skin • 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 wounds 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 have high blood pressure, heart disease, or kidney disease • you are taking a diuretic 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 bleeding. • rash, itching or skin irritation 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 doctor before use while breast-feeding and during the first 6 months of pregnancy.

Do not use during the last 3 months of pregnancy 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 33 words ▾

Other information • Store at 20-25°C (68-77°F) • 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 12 words ▾

Active Ingredient Purpose Methyl Salicylate 10% (NSAID: Nonsteroidal anti-inflammatory drug) Topical Analgesic

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients Adhesive, myrrh gum, zinc oxide.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 79643-0002-01 · PHARMACURE 79643-0004-01 · PHARMACURE →
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.