Biofreeze Roll-On and Overnight Roll-On Menthol Kit
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per each | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leader Cooling Pain Relief Topical Analgesic 40 mg/mL 70000-0618-01 | Cardinal | 89 ml | $0.052 | — | Availability likely | — |
| Leader Roll-On Cooling Pain Relief Topical Analgesic 40 mg/mL 70000-0617-01 | Cardinal | 74 ml | $0.059 | — | Availability likely | — |
| Gel Cooling Pain Relief 40 mg/mL 11344-0894-18 | Nice-Pak | 74 ml | — | — | FDA listed | — |
| Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On 40 mg/mL 11673-0261-03 | TARGET | 89 ml | — | — | FDA listed | — |
| Gel Cooling Pain Relief 40 mg/mL 30142-0043-18 | The | 74 ml | — | — | FDA listed | — |
| TopCare Pain Relieving Roll-On Topical Analgesic 40 mg/mL 36800-0290-01 | Topco | 74 ml | — | — | FDA listed | — |
| 4% Menthol PAIN RELIEF 4 g/100mL 43473-0095-25 | Nantong | 74 ml | — | — | FDA listed | — |
| 4% Menthol Cold Therapy 4 g/100g 43473-0098-15 | Nantong | 1 tube | — | — | FDA listed | — |
| Dragon with Arnical Pain Relief 4 g/100g 50066-0621-56 | Genomma | 1 tube | — | — | FDA listed | — |
| Biofreeze Roll-On 40 mg/mL 50090-6358-00 | A-S | 74 ml | — | — | FDA listed | — |
| Biofreeze Colorless 40 mg/mL 50090-6361-00 | A-S | 89 ml | — | — | FDA listed | — |
| GoodSense Cooling Pain Relief 4 g/100mL 50804-0297-03 | Geiss, | 1 tube | — | — | FDA listed | — |
| CVS Pain Relief Lavender Scent 4 g/100mL 51316-0118-02 | CVS | 74 ml | — | — | FDA listed | — |
| CVS Pain Relief 4 g/100mL 51316-0161-02 | CVS | 74 ml | — | — | FDA listed | — |
| CVS Pain Relief 40 mg/mL 51316-0933-03 | CVS | 89 ml | — | — | FDA listed | — |
| CVS Pain Relief 4 g/100g 51316-0997-04 | CVS | 85 g | — | — | FDA listed | — |
| 4% Menthol PAIN RELIEF 4 g/100mL 52000-0439-25 | Universal | 74 ml | — | — | FDA listed | — |
| 4% Menthol Cold Therapy 4 g/100g 52000-0442-15 | Universal | 1 tube | — | — | FDA listed | — |
| DG Health Cold Zone Pain Relieving Topical Analgesic 40 mg/mL 55910-0884-01 | Dolgencorp | 59 ml | — | — | FDA listed | — |
| Biofreeze 40 mg/mL 59316-0102-10 | Reckitt | 5 ml | — | — | FDA listed | — |
| Biofreeze Colorless 40 mg/mL 59316-0103-12 | Reckitt | 89 ml | — | — | FDA listed | — |
| Biofreeze Overnight Gel 40 mg/mL 59316-0121-10 | Reckitt | 89 ml | — | — | FDA listed | — |
| Biofreeze Roll-On 40 mg/mL 59316-0205-10 | Reckitt | 89 ml | — | — | FDA listed | — |
| Biofreeze Colorless Roll-On 40 mg/mL 59316-0206-10 | Reckitt | 1 bottle | — | — | FDA listed | — |
| Biofreeze Overnight Roll-on 40 mg/mL 59316-0207-14 | Reckitt | 74 ml | — | — | FDA listed | — |
| Biofreeze Roll-On and Overnight Roll-Onthis 59316-0209-14 | Reckitt | 2 bottles | — | — | FDA listed | — |
| Pain Relieving 4 g/100g 61010-4403-01 | Safetec | 113.4 g | — | — | FDA listed | — |
| X-Treme Freeze 4 g/100mL 67777-0144-10 | Dynarex | 100 packets | — | — | FDA listed | — |
| Cold Therapy Roll on .04 g/mL 69168-0483-67 | Allegiant | 74 ml | — | — | FDA listed | — |
| Pain Relief Gel Roll On 40 g/L 69396-0184-01 | Trifecta | 1 bottle | — | — | FDA listed | — |
| Tommie Copper Cooling Roller Lavender Scent 4 g/100mL 72562-0185-03 | Tommie | 89 ml | — | — | FDA listed | — |
| DCH Cooling Pain Relief 4 g/100mL 72839-0297-03 | Derma | 89 ml | — | — | FDA listed | — |
| PAIN RELIEF Gel-Tube .04 g/mL 73557-0323-30 | Shanghai | 89 ml | — | — | FDA listed | — |
| PAIN RELIEF Gel-Roll On .04 g/mL 73557-0333-25 | Shanghai | 74 ml | — | — | FDA listed | — |
| BonicaEaseX Colorless Roll-On Menthol Pain Relieving 40 mg/mL 75568-0041-00 | Planet | 3 bottles | — | — | FDA listed | — |
| BonicaEaseX Menthol Pain Relieving 40 mg/mL 75568-0043-00 | Planet | 3 tubes | — | — | FDA listed | — |
| Gel Cooling Pain Relief 40 mg/mL 76162-0894-21 | Topco | 89 ml | — | — | FDA listed | — |
| meijer Cold Therapy Pain Relieving analgesic 40 mg/mL 79481-0087-01 | Meijer | 89 ml | — | — | FDA listed | — |
| meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic 40 mg/mL 79481-0088-01 | Meijer | 74 ml | — | — | FDA listed | — |
| Equate Cold Therapy Pain Relieving Analgesic 40 mg/mL 79903-0021-01 | Wal-Mart | 89 ml | — | — | FDA listed | — |
| Equate Cold Therapy Pain Relieving Roll-on Analgesic 40 mg/mL 79903-0022-01 | Wal-Mart | 74 ml | — | — | FDA listed | — |
| Thera Plus Cold Therapy Pain Relieving Menthol 40 mg/mL 80684-0101-00 | Fourstar | 74 ml | — | — | FDA listed | — |
| Sync Ice 4 g 82944-0300-74 | iON | 1 bottle | — | — | FDA listed | — |
| DIRT Pain Relieving Gel 40 mg/mL 83067-0363-00 | PURIVITAE, | 88 ml | — | — | FDA listed | — |
| DIRT Pain Relieving Gel 40 mg/mL 83067-0463-00 | PURIVITAE, | 88 ml | — | — | FDA listed | — |
| Quality Choice Cold Therapy Gel 40 mg/mL 83324-0007-04 | Chain | 118.2 ml | — | — | FDA listed | — |
| Auvon 4% Menthol Pain Relief Gel .04 mg/mL 83391-0007-01 | SHENZHEN | 89 ml | — | — | FDA listed | — |
| Menthol Pain Relief Gel-Tube .04 g/mL 83602-0323-30 | Guangzhou | 89 ml | — | — | FDA listed | — |
| Menthol Pain Relief Gel-Roll On .04 g/mL 83602-0333-25 | Guangzhou | 74 ml | — | — | FDA listed | — |
| Pain Relief Gel-Tube .04 g/mL 84008-0003-02 | Bullet | 1 bottle | — | — | FDA listed | — |
| Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On 4 g/100mL 84165-0008-01 | Guangzhou | 1 bottle | — | — | FDA listed | — |
| Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On 4 g/100mL 84165-0009-01 | Guangzhou | 1 bottle | — | — | FDA listed | — |
| HEEL PAIN Relief Gel Roll-On .04 g/mL 84165-0011-01 | Guangzhou | 1 bottle | — | — | FDA listed | — |
| PLANTAR FASCIITIS Relief Gel Roll-On 4 g/100mL 84165-0012-01 | Guangzhou | 1 bottle | — | — | FDA listed | — |
| PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) 4 g/100mL 84165-0013-01 | Guangzhou | 1 bottle | — | — | FDA listed | — |
| AVCOO Pain Relief 4 g/100mL 84992-0003-01 | ADP | 89 ml | — | — | FDA listed | — |
| DG Health Cough Drops Assorted Flavors 75712-0001-01 | Dollar | 26 lozenges | — | — | FDA listed | — |
| Menthol 1 kg/kg 59593-0005-01 | Sharp | 25 kg | — | — | FDA listed | — |
| Menthol 1 kg/kg 59593-0004-01 | Sharp | 25 kg | — | — | FDA listed | — |
| Menthol 1 kg/kg 70440-0001-01 | Mentha | 25 kg | — | — | FDA listed | — |
| Home Farmacy 70983-0012-14 | Saje | 1 kit | — | — | FDA listed | — |
| Pocket Farmacy 70983-0014-16 | Saje | 1 kit | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59316-0209-14 You're viewing this | 2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) | 2026-04-01 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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. |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses Uses Roll-on: Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains Uses Overnight Roll-on: Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
⏱️ Dosage and Administration ▾
Directions Directions Roll-on: ■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■ children under 2 years of age: consult a physician ■ wash hands after use with cool water Directions Overnight Roll-on: ■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■ children under 2 years of age: consult a physician ■ wash hands after use with cool water
⚠️ Warnings ▾
Warnings Roll-on: 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, or in conditions affecting children under 12 years of age Warnings Overnight Roll-on: 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 ■ children 2 years to under 12 years of age: use only under adult supervision 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, or in conditions affecting children under 12 years of age
📦 Storage and Handling ▾
Other Information ■ store at 20-25°C (68-77°F) ■ store in a cool dry place away from direct sunlight
🧪 Active Ingredient ▾
Roll-on/Overnight Roll-on: Menthol 4%
🧪 Inactive Ingredients ▾
Roll-on: Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine,Water, Yellow 5 Overnight Roll-on: Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine
🎯 Purpose ▾
Purpose: Pain Relieving Gel