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Capsaicin .05 g/100g Patch, 10 patches — NDC 79643-0012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Capsaicin .05 g/100g Patch, 10 patches — NDC 79643-012-01 (Billing 79643-0012-01)

by PHARMACURE LLC · 10 PATCH in 1 BOX / .005 g in 1 PATCH

This is a package of 10 patches of Capsaicin .05 g/100g Patch from PHARMACURE LLC, marketed since Sep 2025 and currently FDA-listed. It is this product's only package size.

NDC 79643-0012-01
🏷️ FDA NDC (as labeled) 79643-012-01 billing pads the product 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 79643-012-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79643 labeler · 012 product · 01 package
Package marketed since
Sep 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
10 EA per package
Barcode (UPC-A, from the NDC)
3 7964301201 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79643-012-01
Product NDC 79643-012
11-digit billing NDC 79643001201
NCPDP billing unit EA — each (per item)
RxCUI 2722414
UNII S07O44R1ZM
Application # M017
SPL Set ID 119bab58-f129-4ff0-8d81-9c6a7b508dd6
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-01
Route TOPICAL
Dosage form PATCH
Substance CAPSAICIN

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

GCN Seq No 088574
GCN 58715
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 0.05% PATCH
FDB brand name Capsaicin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 088574
  • GCN: 58715
  • HICL (First Databank): 002577
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 2722414
Why two NDCs? The FDA registers this code as 79643-012-01 — 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 → 79643-0012-01. 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 0.05% 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
79643-0012-01 You're viewing this Main listing 10 PATCH in 1 BOX / .005 g in 1 PATCH 2025-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Capsaicin .05 g/100gthis 79643-0012-01 PHARMACURE 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
Sep 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 JC71GJ1F3L
    Myrrh is a natural resin obtained from a tree, traditionally used in medicines and perfumes. It may serve as a flavoring agent, fragrance, or mild preservative in formulations.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesAdhesive, myrrh gum, zinc oxide

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

LabelerPHARMACURE LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code79643
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from PHARMACURE LLC labeler code 79643

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Uses Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, bruises, sprains, and strains

⏱️ Dosage and Administration 144 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 the patch on for more than 8 hours at a time. Instructions for use : Clean and dry the affected area.

Open the pouch and remove one patch. Remove any protective film and apply directly to the affected area of pain. Apply immediately after removal from the protective envelope. - Wash your hands with soap and water after handling the patches.

Reseal pouch containing unused patches after each use. Do not store the 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 167 words ▾

Warnings For external use only . Use only as directed or as directed by a health care professional. Do not use • On wounds, cuts, damaged, or infected skin • On eyes, mouth, genitals, or any other mucous membranes Stop use and ask a physician : If rash, itching, or excessive skin irritation develops.

If conditions worsen. If symptoms persist for more than 7 days. If symptoms clear up and occur again within a few days.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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 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. • Do not apply heat to the treated area immediately before or after use

🧪 Active Ingredient 7 words ▾

Active Ingredient Purpose Capsaicin 0.05% Topical Analgesic

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients Adhesive, myrrh gum, zinc oxide

📄 Package Label / Principal Display Panel 4 words ▾

Product label image description

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

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 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.
← 79643-0011-01 · PHARMACURE 79647-0123-01 · A/S →
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.