HomeNDC LookupIngredientsMenthol, Unspecified Form › 59316-0992-32
Biofreeze Menthol Menthol, Unspecified Form .05 g/g Patch — NDC 59316-0992-32 package photo

Biofreeze Menthol Menthol, Unspecified Form .05 g/g Patch

by Reckitt Benckiser LLC · 1 PATCH in 1 POUCH (59316-992-32) / 20 g in 1 PATCH
NDC 59316-0992-32
🏷️ FDA NDC (as labeled) 59316-992-32 billing pads the product segment with a zero
This package
Contains20 g in 1 patch Pack sizes8 compare ↓
OTC On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 59316-992-32
Product NDC 59316-992
11-digit billing NDC 59316099232
RxCUI 420222, 2109627
UNII L7T10EIP3A
Application # M017
SPL Set ID fb5c8f89-a720-ad32-e053-6294a90a2abe
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-04
Route TOPICAL
Dosage form PATCH
Substance MENTHOL, UNSPECIFIED FORM
GCN Seq No 052742
GCN 19945
HICL code 002608
Ingredient (HICL) Menthol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name BIOFREEZE 5% EXTRA LARGE PATCH
FDB brand name Biofreeze
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 59316-992-32 — 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 → 59316-0992-32. 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

LabelerReckitt Benckiser LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code59316
First marketedMar 2022
Product typeHuman Otc Drug
Portfolio174 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

Label name BIOFREEZE 5% EXTRA LARGE PATCH Ingredient Menthol
📗 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.

💊 What it looks like

ShapeRectangle
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

From the label’s inactive-ingredient sectionLarge Patch: 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide Overnight Relief Patch: Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $1.008 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/gthis 59316-0992-32 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
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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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 Biofreeze Menthol (this brand).

Top reported reactions

Fatigue59
Pain56
Diarrhoea48
Fall45
Arthralgia44
Headache43
Pain In Extremity38

Age at onset

Adult24
Elderly42

Reporter sex

541 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization127
Death30
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 66 29
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
59316-0992-07 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH 2022-03-04 Active
59316-0992-08 12 POUCH in 1 CARTON (59316-992-08) / 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH 2022-03-04 Active
59316-0992-09 5 POUCH in 1 CARTON (59316-992-09) / 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH 2022-03-04 Active
59316-0992-32 You're viewing this 1 PATCH in 1 POUCH (59316-992-32) / 20 g in 1 PATCH 2022-03-04 Active
59316-0992-33 1 PATCH in 1 POUCH (59316-992-33) / 13 g in 1 PATCH 2022-03-04 Active
59316-0992-36 12 POUCH in 1 CARTON (59316-992-36) / 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH 2022-03-04 Active
59316-0992-04 4 PATCH in 1 CARTON (59316-992-04) / 20 g in 1 PATCH 2024-09-07 Active
59316-0992-34 15 PATCH in 1 CARTON (59316-992-34) / 9 g in 1 PATCH 2024-10-01 Active

Pack size FAQ

What quantity is in NDC 59316-0992-32?
NDC 59316-0992-32 is listed by the FDA — 1 patch in 1 pouch / 20 g in 1 patch.
What NDC number is used to bill for this package of Biofreeze Menthol Menthol, Unspecified Form .05 g/g Patch?
Bill NDC 59316-0992-32 — the 11-digit billing format is 59316099232. 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 59316-992-32, 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: 59316-0992-32, written without dashes as 59316099232. 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 59316-0992-32, the first segment (59316) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0992) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (32) 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 Reckitt Benckiser LLC. 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 7 other package presentations of this same product, including 1 patch (59316-0992-07), 1 patch (59316-0992-33), 4 patches (59316-0992-04). 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?
Reckitt Benckiser 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 24 words

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

⏱️ Dosage and Administration 81 words

Directions ■ adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily. ■ children under 12 years of age : consult a physician ■wash hands after use with cool water

⚠️ Warnings 137 words

For external use only. When using this product ■ use only as directed ■ avoid contact with the eyes or on mucous membranes ■ do not apply to wounds or damaged skin ■ do not apply to irritated skin or if excessive irritation develops ■ do not bandage tightly or use with heating pad or device Stop use and ask a doctor if ■ you experience pain, swelling or blistering of the skin ■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ arthritic pain persists for more than 10 days, or redness is present 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

📦 Storage and Handling 18 words

Other Information ■ store at 20-25°C (68-77°F) ■ store in a cool dry place away from direct sunlight

🧪 Active Ingredient 5 words

Menthol 5% Pain Relieving Patch

🧪 Inactive Ingredients 80 words

Large Patch: 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide Overnight Relief Patch: Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

🎯 Purpose 6 words

Menthol 5% Purpose: Pain Relieving Patch

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.