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Icy Hot XL Back and Large Areas Menthol 5 g/100g Patch, 3 patches — NDC 41167-0847-01 package photo

Icy Hot XL Back and Large Areas Menthol 5 g/100g Patch, 3 patches

by Chattem, Inc. · 1 POUCH in 1 CARTON (41167-0847-1) / 3 PATCH in 1 POUCH
NDC 41167-0847-01
🏷️ FDA NDC (as labeled) 41167-0847-1 billing pads the package segment with a zero
This package
Contains3 patches Pack sizes2 compare ↓
Also comes in: 4 patches 41167-0847-02
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) 41167-0847-1
Product NDC 41167-0847
11-digit billing NDC 41167084701
NCPDP billing unit EA — each (per item)
RxCUI 420222
UNII L7T10EIP3A
Application # 505G(a)(3)
SPL Set ID 941de921-c1f5-4293-973e-d3b786c78511
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-12-01
Route TOPICAL
Dosage form PATCH
Substance MENTHOL
Why two NDCs? The FDA registers this code as 41167-0847-1 — 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 → 41167-0847-01. 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

LabelerChattem, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code41167
First marketedDec 2007
Product typeHuman Otc Drug
Portfolio157 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 J94PBK7X8S
    A synthetic polymer derived from acrylic acid monomers. In medicines, it's used as a binder to hold tablet ingredients together and sometimes as a coating agent to control where and how the drug releases in the body.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • 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 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII WC487PR91H
    A synthetic plastic polymer used as a film-coating agent. It forms a protective layer around tablets or capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII JJX07DG188
    A synthetic surfactant derived from nonylphenol and ethylene oxide. It helps dissolve or disperse oily ingredients and acts as an emulsifier to keep liquid components properly mixed in the formulation.
  • 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 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 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statesaluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water  KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA  ©2020 www.icyhot.com   Made in Japan. Icy Hot® - Medicated Patch BACK   & LARGE AREAS aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water  KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch XL BACK & LARGE AREAS aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water  KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch Value Pack aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water  KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2024  Made in Japan.

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.
Try another pack size: 4 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 $1.023 — 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/100gthis 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 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 —
HealthWise Medicated Cold Hot 5 g/100g 71101-0991-30 Veridian 30 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

🏛️
2007
On the market since
Dec 2007
📍
2026
Currently FDA-listed
19 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Icy Hot XL Back and Large Areas (this brand).

Top reported reactions

Pain86
Dyspnoea85
Fatigue84
Pruritus79
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult98
Elderly91

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 103 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
41167-0847-01 You're viewing this 1 POUCH in 1 CARTON (41167-0847-1) / 3 PATCH in 1 POUCH 2007-12-01 Active
41167-0847-02 1 POUCH in 1 CARTON (41167-0847-2) / 4 PATCH in 1 POUCH 2017-03-10 Discontinued by firm

Pack size FAQ

What quantity is in NDC 41167-0847-01?
NDC 41167-0847-01 contains 3 patches — 1 pouch in 1 carton / 3 patch in 1 pouch.
What is the difference between NDC 41167-0847-01 and NDC 41167-0847-02?
Both are Icy Hot XL Back and Large Areas Menthol 5 g/100g Patch — the drug itself is identical. NDC 41167-0847-01 is the 3 patches package, while NDC 41167-0847-02 is the 4 patches package.
What NDC number is used to bill for this package of Icy Hot XL Back and Large Areas Menthol 5 g/100g Patch?
Bill NDC 41167-0847-01 — the 11-digit billing format is 41167084701. 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 41167-0847-1, 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: 41167-0847-01, written without dashes as 41167084701. 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 41167-0847-01, the first segment (41167) is the labeler code FDA assigned to Chattem, Inc.; the middle segment (0847) 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 Chattem, Inc.. 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 1 other package presentation of this same product, including 4 patches (41167-0847-02). 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?
Chattem, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 76 words ▾

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

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

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

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

⏱️ Dosage and Administration ~2 min read ▾

Directions ■ adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to the affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. ■ children under 12 years of age: ask a doctor

Directions ■ adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. ■ children under 12 years of age: ask a doctor

Directions ■ adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to the affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. ■ children under 12 years of age: ask a doctor

Directions adults and children 12 years of age and older: ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. children under 12 years of age: ask a doctor

⚠️ Warnings ~3 min read ▾

Warnings For external use only Do not use on wounds or on irritated or damaged skin with a heating pad When using this product use only as directed do not bandage tightly avoid contact with eyes and mucous membranes do not expose the area to local heat or to direct sunlight rare cases of serious burns have been reported with products of this type a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ redness is present or excessive skin irritation occurs ■ you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product use only as directed do not bandage tightly avoid contact with eyes and mucous membranes do not expose the area to local heat or to direct sunlight rare cases of serious burns have been reported with products of this type a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 16 words ▾

Active Ingredient Menthol 5%

Active Ingredient Menthol 5%

Active Ingredient Menthol 5%

Active Ingredient Menthol 5%

🧪 Inactive Ingredients ~1 min read ▾

Inactive I ngredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O.

Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch BACK & LARGE AREAS

Inactive Ingredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O.

Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch XL BACK & LARGE AREAS

Inactive Ingredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O.

Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch Value Pack

Inactive Ingredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2024 Made in Japan.

🎯 Purpose 12 words ▾

Purpose Topical analgesic

Purpose Topical analgesic

Purpose Topical analgesic

Purpose Topical analgesic

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.