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Biofreeze Triple Target Gel Camphor, Capsaicin, Menthol 60 mg/mL; 100 mg/mL; .5 mg/mL Gel

by Reckitt Benckiser LLC · 1 BOTTLE in 1 CARTON (59316-122-33) / 89 mL in 1 BOTTLE
NDC 59316-0122-33
🏷️ FDA NDC (as labeled) 59316-122-33 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59316-122-33
Product NDC 59316-122
11-digit billing NDC 59316012233
RxCUI 2741687
UNII N20HL7Q941, L7T10EIP3A, S07O44R1ZM
UPC 0731124444912
Application # M017
SPL Set ID 511852c8-7428-3234-e063-6394a90a5bc2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-01
Route TOPICAL
Dosage form GEL
Substance CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Why two NDCs? The FDA registers this code as 59316-122-33 — 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 → 59316-0122-33. 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 marketedMay 2026
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

🧪 What is this product?

Biofreeze Triple Target Gel is a topical over-the-counter product marketed under FDA's monograph rules for topical pain-relief gels. It contains three active ingredients: camphor, menthol, and capsaicin. Camphor and menthol are typically used to produce a cooling or warming sensation on the skin and are commonly found in topical products meant to help with minor aches and muscle discomfort. Capsaicin, derived from chili peppers, is typically included in such products for similar purposes. This gel is applied directly to the skin over the area of concern.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 4YK5Z54AT2
    Denatonium benzoate is a bitter-tasting chemical compound added to medicines to discourage accidental ingestion, especially by children. It serves as a bittering agent with no therapeutic effect on the body.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 G2MB8B7PSM
    Menthyl ethylamido oxalate is a synthetic compound derived from menthol that serves as a cooling or flavoring agent in medicines. It creates a refreshing sensation and improves taste in oral formulations.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII V56DFE46J5
    Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
  • UNII 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
  • UNII MD83SFE959
    A volatile organic liquid used as a solvent and preservative in medications. It helps dissolve active ingredients and other components, and can improve product stability and shelf life.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also states1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Caprylyl Glycol, Carbomer, Denatonium Benzoate, Ethylhexylglycerin, Glycerin, Menthyl Ethylamido Oxalate, Phenoxyethanol, Propanediol, Purified Water, Steareth-2, Steareth-21, T-Butyl Alcohol, Tetrasodium Glutamate Diacetate, Trolamine

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 gPer 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
Biofreeze Triple Target Gel 60 mg/mL; 100 mg/mL; .5 mg/mLthis 59316-0122-33 Reckitt 1 bottle — — FDA listed —
Biofreeze Triple Target Roll-On .5 mg/mL; 60 mg/mL; 100 mg/mL 59316-0208-33 Reckitt 1 bottle — — 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Triple Target Gel (this brand).

Top reported reactions

Fatigue59
Pain56
Diarrhoea47
Fall45
Arthralgia44
Headache43
Pain In Extremity38

Age at onset

Adult24
Elderly41

Reporter sex

535 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization126
Death29
Disabling18
Life-threatening4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 66 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
59316-0122-33 You're viewing this 1 BOTTLE in 1 CARTON (59316-122-33) / 89 mL in 1 BOTTLE 2026-05-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
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 59316-122-33, 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: 59316-0122-33, written without dashes as 59316012233. 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 59316-0122-33, the first segment (59316) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0122) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (33) 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.
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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

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

⏱️ Dosage and Administration 41 words ▾

Directions adults and children 12 years of age and older: rub a thin film over 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 139 words ▾

Warnings For external use only. Flammable: Keep away from excessive heat or open flame 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 16 words ▾

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

🧪 Active Ingredient 8 words ▾

Active ingredient Camphor 6% Capsaicin 0.05% Menthol 10%

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Caprylyl Glycol, Carbomer, Denatonium Benzoate, Ethylhexylglycerin, Glycerin, Menthyl Ethylamido Oxalate, Phenoxyethanol, Propanediol, Purified Water, Steareth-2, Steareth-21, T-Butyl Alcohol, Tetrasodium Glutamate Diacetate, Trolamine

🎯 Purpose 4 words ▾

Purpose Pain Relieving Gel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59316-0121-10 · Reckitt 59316-0205-10 · Reckitt →
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.