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MENTHOL 5% 500 mg/10g Patch — NDC 80425-0543-01 package photo

MENTHOL 5% 500 mg/10g Patch

by Advanced Rx of Tennessee, LLC · 30 PATCH in 1 BOX (80425-0543-1) / 11 g in 1 PATCH
NDC 80425-0543-01
🏷️ FDA NDC (as labeled) 80425-0543-1 billing pads the package segment with a zero
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 →

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) 80425-0543-1
Product NDC 80425-0543
11-digit billing NDC 80425054301
NCPDP billing unit EA — each (per item)
RxCUI 420222
UNII C6B1OE8P3W
Application # M017
SPL Set ID 3bdd0c52-29d8-ab67-e063-6294a90a9c45
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-08
Route TRANSDERMAL
Dosage form PATCH
Substance MENTHOL, (+)-
Why two NDCs? The FDA registers this code as 80425-0543-1 — 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 → 80425-0543-01. 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

LabelerAdvanced Rx of Tennessee, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code80425
First marketedAug 2025
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 Read our full Menthol 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 OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • 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 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 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 R9XLF1R1WM
    Frankincense is a natural resin from the Boswellia tree. It's used in medicines as a binder or thickener to help hold ingredients together and improve the product's consistency and texture.
  • 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extra Strength Cold-Hot Medicated Patches 5 g 70000-0367-01 Cardinal 5 patches $0.772 — FDA listed —
Rugby Menthol Hot Cold Patch 5 g/100g 00536-1332-15 RUGBY 5 patches $1.023 — Availability likely —
Good Neighbor Pharmacy Cold Therapy Pain Relief Patch 5 g/100g 46122-0751-45 Amerisource 5 patches $1.023 — Availability likely —
Walgreens Cool N Heat Back Patch 50 mg/g 00363-6657-05 Walgreen 5 patches — — FDA listed —
Walgreens Cold Therapy Pain Relieving Patch 50 mg/g 00363-6669-05 Walgreen 5 patches — — FDA listed —
Walgreens Cool N Heat Patch XL 50 mg/g 00363-6672-03 Walgreen 3 patches — — FDA listed —
Hot and Cold Medicated Patch 5 g/100g 00363-9520-05 Walgreen 5 pouches — — FDA listed —
Extra Large Cool and Heat Patch 5 g/100g 00363-9905-03 Walgreen 3 pouches — — FDA listed —
Walgreens Cold Therapy Pain Relief Patch 5 g/100g 00363-9950-05 Walgreens 5 patches — — FDA listed —
Cold and Hot Medicated 500 mg 10742-1117-01 The 5 patches — — FDA listed —
Cold and Hot Medicated 240 mg 10742-1118-01 The 5 patches — — FDA listed —
WellPatch Cooling Pain Relief 50 mg 10742-8125-01 The 1 patch — — Discontinued —
Up and Up Cold and Hot Medicated 50 mg 11673-0887-05 TARGET 1 patch — — Discontinued —
Extra Strength Cold and Hot Menthol Patch 5 g/100g 11822-6513-01 Rite 5 patches — — FDA listed —
Rite Aid Hot and Cold Back Patch 5 g/100g 11822-9991-03 Rite 3 patches — — FDA listed —
Signature Care Cold and Hot Medicated 50 mg 21130-0980-01 Safeway 5 patches — — FDA listed —
Signature Care Medicated Cold and Hot Patch 5 g/100g 21130-0987-05 Safeway 5 patches — — FDA listed —
Kroger Hot and Cold Medicated Patch 5 g/100g 30142-0979-05 Kroger 5 pouches — — FDA listed —
Topcare Cold and Hot Medicated 50 mg 36800-0860-05 Topco 5 patches — — FDA listed —
Icy Hot Back and Large Areas 5 g/100g 41167-0073-08 Chattem, 10 patches — — FDA listed —
Icy Hot Back and Large Areas 5 g/100g 41167-0083-02 Chattem, 1 patch — — FDA listed —
Icy Hot Arm Neck Leg and Small Areas 5 g/100g 41167-0084-01 Chattem, 5 patches — — FDA listed —
Icy Hot Back and Large Areas 5 g/100g 41167-0843-01 Chattem, 5 patches — — FDA listed —
Icy Hot XL Back and Large Areas 5 g/100g 41167-0847-01 Chattem, 3 patches — — FDA listed —
ICY Hot Value Pack 41167-0854-00 Chattem, 5 patches — — FDA listed —
Meijer Small Cold-Hot Medicated Patches 5 g 41250-0522-05 Meijer 5 patches — — FDA listed —
Meijer Large Cold-Hot Medicated Patches 5 g 41250-0834-05 Meijer 5 patches — — FDA listed —
Equate Menthol Pain Relieving 50 mg 49035-0870-01 Wal-Mart 1 patch — — FDA listed —
Equate Cool and Heat Extra Strength 50 mg 49035-0888-30 Wal-Mart 5 patches — — FDA listed —
Good Sense Hot and Cold Medicated Patch 5 g/100g 50804-0124-13 GOOD 5 pouches — — FDA listed —
Goodsense Extra Strength Cold and Hot Medicated 50 mg 50804-0126-05 Geiss, 5 patches — — FDA listed —
CVS Cooling Patch .5 g/10g 51316-0796-02 CVS 2 patches — — FDA listed —
CVS Health Cooling Patch 5 g/100g 51316-0976-10 CVS 10 patches — — FDA listed —
Cold And Hot Medicated Large .05 g/g 52000-0421-41 Universal 1 patch — — FDA listed —
Cold And Hot Medicated .05 g/g 52000-0422-41 Universal 2 patches — — FDA listed —
Medline 5 mg/100mg 53329-0972-05 Medline 5 patches — — FDA listed —
Menthol Pain Relief Gel Patch 50 mg 55629-0025-15 ONE2ZEE 15 patches — — FDA listed —
Dollar General Cold-Hot Medicated Patches 5 g/100g 55910-0903-01 DOLGENCORP, 1 pouch — — FDA listed —
Dollar General Cold Therapy Pain Relief 5 g/100g 55910-0949-01 Dolgencorp, 1 g — — FDA listed —
Dollar General Cold-Hot Medicated Patches 5 g 55910-0972-06 DOLGENCORP, 6 patches — — FDA listed —
Biofreeze Overnight Relief .3 g/6g 59316-0005-03 Reckitt 1 patch — — FDA listed —
Biofreeze Day and Overnight 59316-0832-94 Reckitt 1 patch — — FDA listed —
Biofreeze Menthol 59316-0887-04 Reckitt 1 patch — — FDA listed —
Biofreeze Menthol .05 g/g 59316-0992-07 Reckitt 1 patch — — FDA listed —
Icy Hot Medicated 205.5 mg 62168-0084-03 Lead 1350 patches — — Discontinued —
Icy Hot Medicated, XL 750 mg 62168-0847-04 Lead 400 patches — — FDA listed —
Icy Hot Medicated, Back 428.5 mg 62168-0853-01 Lead 500 patches — — FDA listed —
Winco Cold and Hot Medicated Patch Large 50 mg 67091-0914-05 WINCO 5 patches — — FDA listed —
Hot/Cold Medicated Patch 285 mg/5700mg 67777-0201-10 Dynarex 900 patches — — FDA listed —
Absorbine Jr 5000 mg/h 69693-0412-01 Clarion 1 patch — — FDA listed —
Icequake Coldn Hot medicated patch 50 mg/g 69822-0014-04 Southern 4 patches — — FDA listed —
CVS Cold and Hot 50 mg 69842-0243-05 CVS 5 patches — — FDA listed —
CVS Cold and Hot 50 mg 69842-0245-05 CVS 5 patches — — FDA listed —
Bengay Ultra Strength Large Size 50 mg 69968-0487-01 Kenvue 1 patch — — Discontinued —
HealthWise Medicated Cold Hot 5% Patch 5 g 71101-0031-06 Veridian 6 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 71101-0060-05 Veridian 5 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 71101-0061-05 Veridian 5 patches — — FDA listed —
HealthWise Medicated Cold Hot 5% 5 g 71101-0084-15 Veridian 15 patches — — FDA listed —
HealthWise Overnight Menthol Patch 5 g 71101-0085-12 Veridian 12 patches — — FDA listed —
TheraCare Pain Relief 5 g/100g 71101-0126-01 Veridian 4 patches — — FDA listed —
Thera Care Pain Relief Menthol Patchs 5 g/100g 71101-0913-05 Veridian 5 pouches — — FDA listed —
Theracare Cold Therapy Pain Relief 5 g 71101-0949-01 Veridian 5 patches — — FDA listed —
HealthWise Cold Therapy Pain Relief Patch 5 g/100g 71101-0950-15 Veridian 15 patches — — FDA listed —
Hot and Cold Medicated Patch 5 g/100g 71101-0952-15 Veridian 15 pouches — — FDA listed —
Thera Care Hot and Cold Medicated Patch 5 g/100g 71101-0953-05 Veridian 5 pouches — — FDA listed —
Thera Care Cold Hot Medicated Patch 5 g/100g 71101-0954-05 Veridian 5 pouches — — FDA listed —
Dr Sabharwals 240 mg 71318-0116-15 Dr. 15 patches — — FDA listed —
Menthol 5% 440 mg 71391-0123-18 Unexo 18 patches — — Discontinued —
Menthol 5% Hydrogel 600 mg 71391-0127-05 Unexo 5 patches — — Discontinued —
Cold Hot Medicated Patch 5% Menthol 5 g 71811-0005-05 InterMed 5 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 71811-0006-05 InterMed 5 patches — — FDA listed —
Hot and Cold Medicated Patch 5 g/100g 72036-0952-05 Harris 5 pouches — — FDA listed —
Amazon Basics Cold and Hot Medicated Patch 5 g/100g 72288-0966-15 Amazon.com 15 patches — — FDA listed —
Cycle 5 g/100g 72587-0001-02 La 1 patch — — FDA listed —
Relief 5 g/100g 72587-0003-01 La 4 patches — — FDA listed —
Hempvana Cold As Ice Pain Relief Gel-Patch 5 g/100g 73287-0005-01 Telebrands 7 patches — — FDA listed —
MENTHOL PAIN RELIEF Gel-Patch .05 g/g 73557-0131-15 Shanghai 15 patches — — Discontinued —
OVERNIGHT RELIEF Gel-Patch .05 g/g 73557-0133-05 Shanghai 5 patches — — FDA listed —
Pain Relief .05 g/g 73557-0192-05 Shanghai 5 patches — — FDA listed —
BonicaEaseX 24 Hour Menthol Pain Relieving 50 mg/g 75568-0045-00 Planet 15 patches — — FDA listed —
Topcare Pain Relief Patch 5 g/100g 76162-0999-05 76162 5 patches — — FDA listed —
Meijer Cold Therapy Pain Relieving 5 g/100g 79481-9966-05 Meijer 1 g — — FDA listed —
Menthol 5% 500 mg/10gthis 80425-0543-01 Advanced 30 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 83324-0256-05 Quality 5 patches — — FDA listed —
Hot Cold Medicated Patches 5 g/1001 83559-0003-01 Henan 2 patches — — FDA listed —
COLD AND HOT MEDICATED Patch 5 g/1001 83559-0014-01 Henan 48 patches — — FDA listed —
COLD AND HOT MEDICATED Patch 5 g/1001 83559-0015-01 Henan 24 patches — — FDA listed —
Rapid Relief 5 g/100g 83569-0012-05 RAPID 1 pouch — — FDA listed —
Menthol Pain Relief Gel-Patch .05 g/g 83602-0132-15 Guangzhou 15 patches — — FDA listed —
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patch .05 g/g 84165-0004-01 Guangzhou 12 g — — FDA listed —
AVCOO Menthol Pain Relief Patch 500 mg 84992-0004-01 ADP 1 patch — — FDA listed —
Menthol 5% 500 mg/10g 85096-0301-30 Marcella 30 patches — — FDA listed —
5% Menthol Pain Relief Patch 5 g/100g 85323-0004-00 Xuzhou 5 patches — — FDA listed —
5% Menthol Pain Relief Patch 5 g/100g 85323-0006-01 Xuzhou 48 patches — — FDA listed —
5% Menthol Pain Relief Patch 5 g/100g 85323-0007-01 Xuzhou 24 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
Aug 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80425-0543-01 You're viewing this 30 PATCH in 1 BOX (80425-0543-1) / 11 g in 1 PATCH 2025-08-08 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 80425-0543-1, 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: 80425-0543-01, written without dashes as 80425054301. 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 80425-0543-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx of Tennessee, LLC; the middle segment (0543) 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 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.

📄 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 19 words ▾

USES Temporary relief from minor aches and pains of sore muscles and joints associated with: arthrits backache strains sprains

⏱️ Dosage and Administration 76 words ▾

DIRECTIONS: Adults and Children 12 Years of Age or Over: Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use. Children Under 12 Years of Age: Consult physician.

⚠️ Warnings 5 words ▾

WARNINGS For external use only.

🧪 Active Ingredient 7 words ▾

ACTIVE INGREDIENTS (IN EACH PATCH) Menthol 5%

🧪 Inactive Ingredients 43 words ▾

OTHER INGREDIENTS Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water

🎯 Purpose 3 words ▾

PURPOSE External Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80425-0542-01 · Advanced 80425-0544-01 · 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.