HomeNDC LookupIngredientsMethyl Salicylate › 50488-1015-05
Methyl Salicylate 250 mg/g Cream, 50 g — NDC 50488-1015-05 package photo

Methyl Salicylate 250 mg/g Cream, 50 g

by Alexso, Inc · 50 g in 1 BOTTLE (50488-1015-5)
NDC 50488-1015-05
🏷️ FDA NDC (as labeled) 50488-1015-5 billing pads the package segment with a zero
This package
Contains50 g Pack sizes2 compare ↓
Also comes in: 120 g 50488-1015-01
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 →

🆔 Identity & classification

FDA NDC (as labeled) 50488-1015-5
Product NDC 50488-1015
11-digit billing NDC 50488101505
NCPDP billing unit GM — per gram (weight)
RxCUI 238542
UNII LAV5U5022Y
UPC 0050488101515
Application # M017
SPL Set ID eef555d3-f23d-4847-93f3-fa7a06072a0f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-01
Route TOPICAL
Dosage form CREAM
Substance METHYL SALICYLATE
GPI-14 90800050003740
GPI class 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 50488-1015-5 — a 5-4-1 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 package segment → 50488-1015-05. 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

LabelerAlexso, Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code50488
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio15 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 →
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.

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.

💲 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: 120 g
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/gthis 50488-1015-05 Alexso, 50 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/g 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 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
50488-1015-01 120 g in 1 BOTTLE (50488-1015-1) 2019-04-01 Active
50488-1015-05 You're viewing this 50 g in 1 BOTTLE (50488-1015-5) 2019-04-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 50488-1015-05?
NDC 50488-1015-05 contains 50 g — 50 g in 1 bottle.
What is the difference between NDC 50488-1015-05 and NDC 50488-1015-01?
Both are Methyl Salicylate 250 mg/g Cream — the drug itself is identical. NDC 50488-1015-05 is the 50 g package, while NDC 50488-1015-01 is the 120 g package.
What NDC number is used to bill for this package of Methyl Salicylate 250 mg/g Cream?
Bill NDC 50488-1015-05 — the 11-digit billing format is 50488101505. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — 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 50488-1015-5, 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: 50488-1015-05, written without dashes as 50488101505. 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 50488-1015-05, the first segment (50488) is the labeler code FDA assigned to Alexso, Inc; the middle segment (1015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Alexso, 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 1 other package presentation of this same product, including 120 g (50488-1015-01). 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?
Alexso, 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.

📄 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 25 words

Uses For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

⏱️ Dosage and Administration 29 words

Directions adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor

⚠️ Warnings 95 words

Warnings ​For external use only. When using this product Avoid contact with the eyes Do not use in large quantities, particularly over raw surfaces or blistered areas Do not apply to wounds or damaged skin Do not bandage Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 22 words

Other information May be applied under occlusive dressing. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

🧪 Active Ingredient 5 words

Active ingredient Methyl Salicylate 25%

🧪 Inactive Ingredients 65 words

Inactive ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine Methyl Salicylate 25% Cream NDC: 50488-1015-5 50 grams Methyl Salicylate 25 % Cream NDC: 50488-1015-1 120 grams Manufactured for: Alexso, Inc Los Angeles, CA 90064

🎯 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 ↗
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.