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Biofreeze Foot Cream MENTHOL 100 mg/g Cream, 85 g — NDC 59316-0001-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Biofreeze Foot Cream MENTHOL 100 mg/g Cream, 85 g — NDC 59316-001-10 (Billing 59316-0001-10)

by Reckitt Benckiser LLC · 85 g in 1 TUBE

This is a package of 85 g of Biofreeze Foot Cream MENTHOL 100 mg/g Cream from Reckitt Benckiser LLC, marketed since Mar 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 59316-0001-10
🏷️ FDA NDC (as labeled) 59316-001-10 billing pads the product segment with a zero
This package
Contains85 g Pack sizes2 compare ↓
Main listing for product 59316-001 · Also comes in: 113.3 g 59316-001-20
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 59316-001-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59316 labeler · 001 product · 10 package
Package marketed since
Mar 12, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5931600110 3
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59316-001-10
Product NDC 59316-001
11-digit billing NDC 59316000110
RxCUI 253020, 2001133
UNII L7T10EIP3A
Application # M017
SPL Set ID 32450cbf-4ed4-402b-a30e-e08a17bba3fb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-12
Route TOPICAL
Dosage form CREAM
Substance MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 253020
Why two NDCs? The FDA registers this code as 59316-001-10 — 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 → 59316-0001-10. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 Read our full Menthol guide →

Supplement & herbal interactions

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

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.
Try another pack size: 113.3 g
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59316-0001-10 You're viewing this Main listing 85 g in 1 TUBE 2021-03-12 — Active
59316-0001-20 59316-001-20 113.3 g in 1 TUBE 2021-03-12 — Active

Pack size FAQ

What quantity is in this package?
This package contains 85 g — 85 g in 1 tube.
How does this package differ from NDC 59316-0001-20?
Both are Biofreeze Foot Cream MENTHOL 100 mg/g Cream — the drug itself is identical. This page's package is the 85 g one, while NDC 59316-0001-20 is the 113.3 g package.
What NDC number is used to bill for this package of Biofreeze Foot Cream MENTHOL 100 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Cold Therapy Pain Relief Foot Cream 100 mg/g 00363-1292-04 Walgreen 113 g — — FDA listed —
Menthol Pain Relieving Cream with Menthol 10% .1 g/g 55629-0018-05 ONE2ZEE 141 g — — FDA listed —
Biofreeze Foot Cream 100 mg/gthis 59316-0001-10 Reckitt 85 g — — FDA listed —
Biofreeze Foot Pain Relief Set 59316-0002-10 Reckitt 1 kit — — FDA listed —
Biofreeze 100 mg/g 59316-0869-10 Reckitt 85 g — — FDA listed —
Biofreeze 100 mg/g 59316-0870-10 Reckitt 85 g — — FDA listed —
PROINNATE Numbing Cream 10 g/100g 60771-0024-01 Guangzhou 120 g — — FDA listed —
PROINNATE Numbing Cream 10 g/100g 60771-0039-01 Guangzhou 30 g — — FDA listed —
CVS Health Pain Relief Foot 100 mg/g 66902-0292-04 NATURAL 113 g — — FDA listed —
HealthWise Pain Relieving Cream 10 g/100g 71101-0075-01 Veridian 1 jar — — FDA listed —
HealthWise Pain Relieving Cream Lavender 10 g/100g 71101-0076-01 Veridian 1 jar — — FDA listed —
Debbies Down and Dirty Deep Tissue Joint and Muscle 100 mg/mL 71523-0833-01 DD&D 1 bottle — — FDA listed —
Relieve Your Pain 10 g/100g 72683-0005-01 Proximity 96 g — — FDA listed —
KINETIC ICE Muscle and Joint Pain Relief Cream 100 mg/mL 81050-0108-00 No 118 ml — — FDA listed —
Deep Numbing Cream 10 g/100g 83364-0023-01 YITONGBADA 1 bottle — — FDA listed —
The Body Builders Cream 100 mg/mL 87282-0912-00 Smart 100.6 ml — — FDA listed —
Joint and Muscle Relief Topical Analgesic 100 mg/mL 87282-0988-00 Smart 100.6 ml — — 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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.

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.

🧪 Avoiding an ingredient? See Menthol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • 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 1Q953B4O4F
    Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
  • UNII 603P14DHEB
    A synthetic antimicrobial chemical used as a preservative in topical and cosmetic formulations. It prevents bacterial and fungal growth in products to maintain stability and safety during storage and use.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII IN99IT31LN
    Sodium stearoyl lactylate is a synthetic compound made from stearic acid and lactic acid. It works as an emulsifier to help keep oils and water mixed together, and as a dough conditioner in solid dosage forms.
  • 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 statesCaprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerReckitt Benckiser LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code59316
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio176 products on file

More NDCs from Reckitt Benckiser LLC labeler code 59316

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.

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

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 130 words ▾

Warnings 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 16 words ▾

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

🧪 Active Ingredient 4 words ▾

Active ingredient Menthol 10%

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

🎯 Purpose 4 words ▾

Purpose Pain Relieving Cream

📄 When Using This Product 47 words ▾

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 49 words ▾

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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-246-3733

📄 Package Label / Principal Display Panel 36 words ▾

PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label CLINICALLY RECOMMENDED* NDC 59316-001-20 BiOFREEZE ® COOL THE PAIN FOOT CREAM MENTHOL-PAIN RELIEVING CREAM Net wt 4 OZ (113.3 g) PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label

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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 1 other package presentation of this same product, including 113.3 g (59316-0001-20). 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.
← 59310-0822-06 · Teva 59316-0002-10 · 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.