HomeNDC LookupIngredientsMenthol › 84992-0004-01
AVCOO Menthol Pain Relief Patch 500 mg Patch, 1 patch — NDC 84992-0004-01 package photo

AVCOO Menthol Pain Relief Patch 500 mg Patch, 1 patch

by ADP Health Limited · 1 PATCH in 1 BAG (84992-004-01)
NDC 84992-0004-01
🏷️ FDA NDC (as labeled) 84992-004-01 billing pads the product segment with a zero
This package
Contains1 patch Pack sizes3 compare ↓
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 →
⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 84992-004-01
Product NDC 84992-004
11-digit billing NDC 84992000401
RxCUI 420222
UNII BZ1R15MTK7
Application # M017
SPL Set ID 3036804b-16c3-0c88-e063-6394a90a3084
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-13
Route TOPICAL
Dosage form PATCH
Substance LEVOMENTHOL
Why two NDCs? The FDA registers this code as 84992-004-01 — 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 → 84992-0004-01. 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

LabelerADP Health Limited
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code84992
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio4 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 →
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 99H65D77XY
    A plant-derived thickener made from cellulose. It absorbs water and increases viscosity, helping the medicine stay stable and flow properly. Commonly used as a binder and thickening agent in liquid and solid formulations.
  • UNII DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • 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 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 9G2MAD7J6W
    Polyacrylic acid is a synthetic polymer used as a binder and thickening agent in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid or semi-solid 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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.

19 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 L-Tartaric Acid Mineral Oil Petrolatum Polyacrylic Acid Polysorbate 80 Propylene Glycol PVP 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 DailyMedingredient 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.
Try another pack size: 10 patches 18 patches
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 $1.008 Availability likely
Good Neighbor Pharmacy Cold Therapy Pain Relief Patch 5 g/100g 46122-0751-45 Amerisource 5 patches $1.008 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/10g 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 mgthis 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
Mar 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.

🔬 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 AVCOO Menthol Pain Relief Patch (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Reporter sex

0 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Death125
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 96 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
84992-0004-01 You're viewing this 1 PATCH in 1 BAG (84992-004-01) 2025-03-13 Active
84992-0004-02 10 PATCH in 1 BOX (84992-004-02) 2025-03-13 Active
84992-0004-03 18 PATCH in 1 BOX (84992-004-03) 2025-03-13 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84992-0004-01?
NDC 84992-0004-01 contains 1 patch — 1 patch in 1 bag.
What is the difference between NDC 84992-0004-01 and NDC 84992-0004-02?
Both are AVCOO Menthol Pain Relief Patch 500 mg Patch — the drug itself is identical. NDC 84992-0004-01 is the 1 patch package, while NDC 84992-0004-02 is the 10 patches package.
What NDC number is used to bill for this package of AVCOO Menthol Pain Relief Patch 500 mg Patch?
Bill NDC 84992-0004-01 — the 11-digit billing format is 84992000401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 84992-004-01, 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: 84992-0004-01, written without dashes as 84992000401. 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 84992-0004-01, the first segment (84992) is the labeler code FDA assigned to ADP Health Limited; the middle segment (0004) 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 ADP Health Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 patches (84992-0004-02), 18 patches (84992-0004-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ADP Health Limited 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 5 words

for the temporary pain relief

⏱️ Dosage and Administration 76 words

■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the ■ Do not repeatedly use or repeatedly reapply the patch as far as possible ■ Cut first if if used on joints ■ Use in te affected area no more than 4 times daily ■ Wash hands with cool water after use

⚠️ Warnings 4 words

For external use only

📦 Storage and Handling 18 words

Avoid storing patches in direct sunlight Protect patches from excessive moisture P lease store it at room temperature.

🧪 Active Ingredient 2 words

Menthol 5%

🧪 Inactive Ingredients 42 words

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 L-Tartaric Acid Mineral Oil Petrolatum Polyacrylic Acid Polysorbate 80 Propylene Glycol PVP Sodium Polyacrylate Titanium Dioxide Water

🎯 Purpose 2 words

Topical anesthetic

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