DIRT Pain Relieving Gel MENTHOL 40 mg/mL Gel, 88 mL
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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UNII 2P3VWU3H10
Activated charcoal is a highly porous carbon material processed to increase its surface area. It's used in medicines as an absorbent to help bind and remove unwanted substances in the digestive system.
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UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
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UNII OZ0E5Y15PZ
A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
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UNII P0M7O4Y7YD
A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
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UNII 9H4PO4Z4FT
A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
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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.
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UNII 2R04ONI662
Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
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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.
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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.
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UNII 4PW41QCO2M
Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
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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.
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UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII VIF565UC2G
Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
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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.
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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.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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?
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 g | 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-On 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/mLthis 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 | — |
| Dr. Carrasco Pain Relief 40 mg/mL 69921-0024-01 | Carrasco | 89 ml | — | — | FDA listed | — |
| Nerve Reverse Pain Relief 40 mg/mL 73067-0870-04 | Pogue | 118 ml | — | — | 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 |
|---|---|---|---|
| 83067-0463-00 You're viewing this | 88 mL in 1 BOTTLE (83067-463-00) | 2023-10-03 | Active |
🧭 About this NDC listing & data coverage
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. |
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: For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.
⏱️ Dosage and Administration ▾
Directions: Adults and children over 12 years of age: ask a doctor Children 12 years or younger: apply generously to affected areas rub into affected area until absorbed into the skin repeat as necessary, but no more than 4 times daily
⚠️ Warnings ▾
Warnings: For external use only Do not use on damaged or broken skin When using this product avoid contact with the eyes or mucous membranes do not bandage tightly Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away If pregnant or breast-feeding, ask a health professional before use
🧪 Active Ingredient ▾
Active Ingredients: Menthol 4% Purpose Topical Analgesic
🧪 Inactive Ingredients ▾
Inactive Ingredients: Activated Charcoal, Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, llex Paraguariensis (Verba Mate') Extract, Melaleuca Alternilolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.
🎯 Purpose ▾
Purpose Topical Analgesic