Home › NDC Lookup › Ingredients › Methyl Salicylate, Menthol › 80425-0369-01
🧴image loading
(from DailyMed)

Calypxo Pain Relief Methyl Salicylate, Menthol 10 g/100g; 3 g/100g Cream, 113 g — NDC 80425-0369-1 (Billing 80425-0369-01)

by Advanced Rx of Tennessee, LLC · 113 g in 1 BOTTLE

This is a package of 113 g of Calypxo Pain Relief Methyl Salicylate, Menthol 10 g/100g; 3 g/100g Cream from Advanced Rx of Tennessee, LLC, marketed since Dec 2023 and currently FDA-listed. It is this product's only package size.

NDC 80425-0369-01
🏷️ FDA NDC (as labeled) 80425-0369-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0369-1
Product NDC 80425-0369
11-digit billing NDC 80425036901
NCPDP billing unit GM — per gram (weight)
RxCUI 1486874
UNII LAV5U5022Y, L7T10EIP3A
Application # M017
SPL Set ID 0b7736df-c7e0-7d00-e063-6294a90aa57e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-01
Route TOPICAL
Dosage form CREAM
Substance METHYL SALICYLATE; MENTHOL
Quick answers
  • RxCUI (RxNorm): 1486874
Why two NDCs? The FDA registers this code as 80425-0369-1 — 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 → 80425-0369-01. 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.

Clinical

📗 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80425-0369-01 You're viewing this Main listing 113 g in 1 BOTTLE 2023-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Geliga Muscular 3 g/100g; 10 g/100g 60954-0004-30 PT. 1 tube — — FDA listed —
Calypxo Pain Relief 10 g/100g; 3 g/100g 76420-0450-12 Asclemed 113 g — — FDA listed —
Calypxo Pain Relief 10 g/100g; 3 g/100gthis 80425-0369-01 Advanced 113 g — — FDA listed —
Numbing 3 g/100mL; 10 g/100mL 85524-2605-02 FlexiGo 1 bottle — — 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
Dec 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.

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

LabelerAdvanced Rx of Tennessee, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code80425
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio280 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

⏱️ Dosage and Administration 20 words ▾

Directions For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

⚠️ Warnings 82 words ▾

Warning For external use only. Avoid contact with eyes and mucous membranes. Do not bandage tightly or cover treated areas.

Do not use with heating pad. Do not apply to open wounds or damages skin. A mild burning sensation may occur.

If severe burning sensation occurs, discontinue use immediately. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children.

If swallowed, consult physician. If pregnant or breast feeding, contact physician prior to use.

🧪 Active Ingredient 5 words ▾

Active Ingredients Methyl Salicylate………10.00% Menthol…………………3.00%

🧪 Inactive Ingredients 33 words ▾

Other Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

🎯 Purpose 5 words ▾

Purpose Topical Analgesic Topical Analgesic

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, consult physician. If pregnant or breast feeding, contact physician prior to use.

📄 Package Label / Principal Display Panel 6 words ▾

Principal Display Panel Calypxo Cream 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Calypxo Pain Relief (this brand).

Top reported reactions

Back Pain1
Blood Prolactin Increased1
Breast Discharge1
Breast Pain1
Rash Pruritic1
Refusal Of Treatment By Patient1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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.

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) — 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 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 Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx of Tennessee, 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.
← 80425-0368-01 · Advanced 80425-0370-01 · Advanced →
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.