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Calypxo HP Pain Relief Methyl Salicylate, Menthol 15 g/100g; 10 g/100g Cream, 113 g — NDC 76420-0999-01 package photo

Calypxo HP Pain Relief Methyl Salicylate, Menthol 15 g/100g; 10 g/100g Cream, 113 g

by Asclemed USA, Inc · 113 g in 1 BOTTLE (76420-999-01)
NDC 76420-0999-01
🏷️ FDA NDC (as labeled) 76420-999-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 76420-999-01
Product NDC 76420-999
11-digit billing NDC 76420099901
NCPDP billing unit GM — per gram (weight)
RxCUI 311498
UNII LAV5U5022Y, L7T10EIP3A
UPC 0376420999010
Application # M017
SPL Set ID 89a8c267-bd92-4d0d-8e50-c52224aff9cd
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-10
Route TOPICAL
Dosage form CREAM
Substance METHYL SALICYLATE; MENTHOL
GPI-14 90809902603700
GPI class Calypxo HP
GCN Seq No 061801
GCN 97586
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 CALYPXO HP CREAM
FDB brand name Calypxo Hp
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 76420-999-01 — 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 → 76420-0999-01. 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

LabelerAsclemed USA, Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code76420
First marketedDec 2020
Product typeHuman Otc Drug
Portfolio8 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 CALYPXO HP CREAM Ingredient Methyl Salicylate/Menthol
📗 Our plain-language guide HelloPharmacist
  • These products are designed for temporary relief of mild to moderate muscle and joint pain — things like arthritis, a sore back, sprains, strains, bruises, and cramps. Medistik Dua...
  • What kinds of pain does this actually help with?
  • A mild burning or warming sensation right after you apply it is completely normal and is actually expected. It usually fades within a few days of regular use. What you should NOT i...
  • I feel a burning sensation after I put it on — is that normal?
📖 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.

🧪 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • 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 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesAcrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

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
Muscle Rub 100 mg/g; 150 mg/g 00536-1349-57 Rugby 1 tube $0.037 — Availability likely —
Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g 11527-0057-40 Sheffield 1 tube — — FDA listed —
Arthritis Hot 10 g/100g; 15 g/100g 41167-0600-03 Chattem, 1 tube — — FDA listed —
CVS Muscle Rub 150 mg/g; 100 mg/g 51316-0994-03 CVS 85 g — — FDA listed —
CAREALL Muscle Rub Ultra Strength 100 mg/g; 150 mg/g 51824-0007-03 New 85 g — — FDA listed —
CAREALL Muscle Rub Ultra Strength 100 mg/g; 150 mg/g 51824-0105-03 New 85 g — — FDA listed —
Analgesic Balm 10 g/100g; 15 g/100g 57896-0116-01 Geri-Care 1 tube — — FDA listed —
DynaRub 10 g/100g; 15 g/100g 67777-0113-50 Dynarex 72 tubes — — FDA listed —
Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g 68071-1624-05 NuCare 35 g — — FDA listed —
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 68071-3789-03 NuCare 1 tube — — FDA listed —
Muscle Rub Cream 10 g/100g; 15 g/100g 68788-8544-08 Preferred 1 tube — — FDA listed —
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 68788-8729-08 Preferred 1 tube — — FDA listed —
Muscle Rub Cream .1 g/100g; .15 g/100g 69396-0024-05 Trifecta 1 tube — — FDA listed —
Muscle Rub Cream 10 g/100g; 15 g/100g 69396-0110-30 Trifecta 1 tube — — FDA listed —
Pain Reliever Cream 10 g/100g; 15 g/100g 69396-0151-01 Trifecta 1 tube — — FDA listed —
TheraCare Muscle and Join Pain Relieving Cream 100 mg/g; 150 mg/g 71101-0012-01 Veridian 1 tube — — FDA listed —
AsperFlex 100 mg/g; 150 mg/g 71399-6854-03 Akron 85 g — — FDA listed —
Calypxo HP Pain Relief 15 g/100g; 10 g/100gthis 76420-0999-01 Asclemed 113 g — — FDA listed —
Muscle Rub 10 g/100g; 15 g/100g 87236-0005-01 Aldermed 1 tube — — 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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 Calypxo HP 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76420-0999-01 You're viewing this 113 g in 1 BOTTLE (76420-999-01) 2020-12-10 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 76420-999-01, 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: 76420-0999-01, written without dashes as 76420099901. 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 76420-0999-01, the first segment (76420) is the labeler code FDA assigned to Asclemed USA, Inc; the middle segment (0999) 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 Asclemed USA, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Asclemed USA, 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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 78 words ▾

Warning For external use only. Avoid contact with eyes and mucous membranes. Do not bandage tightly or cover treated areas. use with heating pad. 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………15.00% Menthol……………………10.00%

🧪 Inactive Ingredients 27 words ▾

Other Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

🎯 Purpose 5 words ▾

Purpose Topical Analgesic Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76420-0992-01 · Asclemed 76431-0110-01 · Amryt →
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.