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Methyl Salicylate 250 mg/g Cream, 100 g — NDC 79643-0004-01 package photo

Methyl Salicylate 250 mg/g Cream, 100 g

by PHARMACURE LLC · 100 g in 1 TUBE (79643-004-01)
NDC 79643-0004-01
🏷️ FDA NDC (as labeled) 79643-004-01 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) 79643-004-01
Product NDC 79643-004
11-digit billing NDC 79643000401
NCPDP billing unit GM — per gram (weight)
RxCUI 238542
UNII LAV5U5022Y
Application # M017
SPL Set ID f119a1bd-095f-41f5-86d5-c0ee4f19fd2c
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 CREAM
Substance METHYL SALICYLATE
GCN Seq No 006052
GCN 23712
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 25% CREAM
FDB brand name Methyl Salicylate
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 79643-004-01 — 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 → 79643-0004-01. 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 marketedMay 2024
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 25% CREAM 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 OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 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 TD1MUT01Q7
    Hemp is a plant-derived ingredient used as a binder or filler in solid dosage forms like tablets and capsules. It helps hold other ingredients together and adds bulk to the medicine.
  • UNII 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII Q369O8926L
    Resveratrol is a plant-derived compound sometimes added to supplements and fortified products. It may serve as an active nutritional ingredient rather than a traditional inactive filler, though its exact formulation role varies by product.
  • UNII Z6GFR7R72Y
    A plant-derived cleaning agent used as a surfactant and emulsifier. It helps mix water and oil-based ingredients together and improves how the medicine spreads or is absorbed.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 statesAqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbital olivate, stearic acid

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.
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
AVON footworks Arthritis Achy Foot and Muscle 250 mg/mL 10096-4001-01 The 1 tube — — FDA listed —
Methyl Salicylate 250 mg/g 50488-1015-01 Alexso, 120 g — — FDA listed —
Methyl Salicylate 25 Percent 250 mg/mL 50488-1016-05 Alexso, 50 ml — — FDA listed —
Methyl Salicylate 25% Pain Relieving 250 mg/g 59088-0014-06 Puretek 60 g — — FDA listed —
Methylten 25% Pain Relieving 250 mg/g 59088-0245-06 PureTek 60 g — — FDA listed —
Methyl Salicylate 25 g/60g 73492-0273-60 ALAINA 1 tube — — FDA listed —
Methyl Salicylate 250 mg/gthis 79643-0004-01 PHARMACURE 100 g — — FDA listed —
Methyl Salicylate 25% Cream 250 mg/g 80425-0544-01 Advanced 120 g — — FDA listed —
Methyl Salicylate 25% Cream 250 mg/mL 82461-0415-05 Medcore 50 ml — — FDA listed —
Methyl Salicylate 25% Cream 250 mg/g 85096-0001-42 MARCELLA 120 g — — FDA listed —
Methyl Salicylate 25 g/60g 85231-0201-60 ViolaCare, 1 tube — — FDA listed —
Methyl Salicylate 25% 250 mg/mL 85477-0301-10 Oncora 118 ml — — FDA listed —
Methyl Salicylate 25% 250 mg/g 85477-0311-10 Oncora 120 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

🏛️
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 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
79643-0004-01 You're viewing this 100 g in 1 TUBE (79643-004-01) 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 ✓ 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 79643-004-01, 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: 79643-0004-01, written without dashes as 79643000401. 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 79643-0004-01, the first segment (79643) is the labeler code FDA assigned to PHARMACURE LLC; the middle segment (0004) 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 🧪 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 37 words ▾

Directions • Use only as directed • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •children under 12 years of age: consult a physician

⚠️ 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) • 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.

🧪 Active Ingredient 12 words ▾

Active Ingredient Purpose Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug) Topical Analgesic

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbital olivate, stearic acid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 79643-0003-01 · PHARMACURE 79643-0005-01 · 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.