Home › NDC Lookup › Ingredients › Capsaicin › 50488-2035-01
Capsaicin 0.035 Percent .035 g/100g Patch — NDC 50488-2035-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Capsaicin 0.035 Percent .035 g/100g Patch — NDC 50488-2035-1 (Billing 50488-2035-01)

by Alexso, Inc · 10 PATCH in 1 CARTON / 100 g in 1 PATCH

This is a package of Capsaicin 0.035 Percent .035 g/100g Patch from Alexso, Inc, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 50488-2035-01
🏷️ FDA NDC (as labeled) 50488-2035-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 50488-2035-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50488 labeler · 2035 product · 1 package
Package marketed since
Jun 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5048820351 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50488-2035-1
Product NDC 50488-2035
11-digit billing NDC 50488203501
NCPDP billing unit EA — each (per item)
RxCUI 2702859
UNII S07O44R1ZM
Application # 505G(a)(3)
SPL Set ID 597e0d44-21f8-4f98-b932-70345462f359
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-01
Route TOPICAL
Dosage form PATCH
Substance CAPSAICIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 087179
GCN 57026
HICL code 002577
Ingredient (HICL) Capsaicin
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 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name CAPSAICIN 0.035% PATCH
FDB brand name Capsaicin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 087179
  • GCN: 57026
  • HICL (First Databank): 002577
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 2702859
Why two NDCs? The FDA registers this code as 50488-2035-1 — 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 → 50488-2035-01. 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.

RxNorm drug class

This medicine belongs to the Capsaicin and similar agents class.

Drug family (ATC) Capsaicin and similar agents, Other local anesthetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CAPSAICIN 0.035% PATCH Ingredient Capsaicin
📖 What it is MedlinePlus · NLM

Capsaicin topical system is used to treat neuropathic pain from postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles) or from diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes). Capsaicin is a substance that is found in chili peppers. Capsaicin topical system is in a class of medications called topical pain relievers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, completely normal — and it actually means the medicine is working. Capsaicin activates the same pain-sensing receptors in your skin that respond to heat and spicy food. That b...
  • Why does capsaicin burn when I put it on? Is that normal?
  • For most OTC creams and ointments, you can apply up to 3 to 4 times a day. For OTC patches, apply to clean, dry skin and remove after no more than 8 hours — again, up to 3 to 4 tim...
  • How often should I apply capsaicin cream or use the patch?
📖 Read our full Capsaicin guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Capsaicin (prescription drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Capsaicin (prescription drug) (3 interactions) — ranked by severity →
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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50488-2035-01 You're viewing this Main listing 10 PATCH in 1 CARTON / 100 g in 1 PATCH 2025-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Capsaicin 0.035 Percent .035 g/100gthis 50488-2035-01 Alexso, 10 patches — — FDA listed —
Capsaicin .035 g/100g 79643-0007-01 PHARMACURE 10 patches — — FDA listed —
Capsaicin 0.035 .035 g/100g 82461-0421-10 Medcore 10 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

🧪 Avoiding an ingredient? See Capsaicin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K713C615K
    A mineral compound of aluminum that acts as an antacid and absorbent in formulations. It helps neutralize stomach acid and is used as a filler or binding agent in solid dosage forms.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • 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 I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesAqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt

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.

Manufacturer & labeler

LabelerAlexso, Inc
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code50488
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from Alexso, Inc labeler code 50488

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses Temporarily relieves minor aches and pains of muscles and joints due to: • arthritis • simple backache • strains • bruises • sprains

⏱️ Dosage and Administration 140 words ▾

Directions Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches. - Reseal pouch containing unused patches after each use.

Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years : Ask a physician

⚠️ Warnings ~1 min read ▾

Warnings For external use only . Use only as directed or as directed by a health care professional Read all warnings and directions before use. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Do not use • On wounds, cuts, damaged or infected skin • On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use. Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe.

With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use Stop use and as k a physician: • If pregnant or breast feeding • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. • If severe burning persists or blistering occurs Keep out of reach of children and pets .

If swallowed, get medical help or contact a Poison Control Center immediately.

📦 Storage and Handling 8 words ▾

Other information Store at room temperature 15°-30°C (59°-86°F)

🧪 Active Ingredient 4 words ▾

Active ingredient Capsaicin 0.035%

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients Aqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt

🎯 Purpose 3 words ▾

Purpose External analgesic

📄 Do Not Use 44 words ▾

Do not use • On wounds, cuts, damaged or infected skin • On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

📄 When Using This Product 70 words ▾

Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use

📄 Stop Use and Ask a Doctor If 53 words ▾

Stop use and as k a physician: • If pregnant or breast feeding • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. • If severe burning persists or blistering occurs

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 28 words ▾

PRINCIPAL DISPLAY PANEL Capsaicin 0.03 5 % Patch NDC 50488-2035-1 10 Patches (5 per Resealable Pouch) Alexso, Inc NDC 50488-2035-1 10 Patches (5 per Resealable Pouch) Alexso, Inc

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 Capsaicin 0.035 Percent (this brand).

Top reported reactions

Fatigue141
Weight Increased99
Pain92
Insomnia89
Poor Quality Sleep75
Hypertension71
Cataract68

Age at onset

Child2
Adolescent4
Adult140
Elderly79

Reporter sex

1,400 reports
Male · 43%
Female · 56%
Unknown · 0%

Serious outcomes

Death73
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 136 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 ✓ 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 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 Alexso, Inc. Listing status can change — the directory data on this page refreshes weekly.
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.
← 50488-2025-01 · Alexso, 50488-6040-06 · Alexso, →
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.