HomeNDC LookupIngredientsMenthol, Unspecified Form › 75568-0043-00
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BonicaEaseX Menthol Pain Relieving MENTHOL, UNSPECIFIED FORM 40 mg/mL Gel

by Planet (Anhui) Pharmaceutical Co.,Ltd · 3 TUBE in 1 BOX (75568-043-00) / 118 mL in 1 TUBE
NDC 75568-0043-00
🏷️ FDA NDC (as labeled) 75568-043-00 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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) 75568-043-00
Product NDC 75568-043
11-digit billing NDC 75568004300
RxCUI 415974
UNII L7T10EIP3A
Application # M017
SPL Set ID 4d84b4fb-8f55-4b2b-b261-858edb7f3144
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-31
Route TOPICAL
Dosage form GEL
Substance MENTHOL, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 75568-043-00 — 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 → 75568-0043-00. 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

LabelerPlanet (Anhui) Pharmaceutical Co.,Ltd
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code75568
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio3 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

📗 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.

🧪 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 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.
  • 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 SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • 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.
  • 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.

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

The official label also states• Arnica Oil • Calendula Oil • Carbomer • Dimethyl Isosorbide • Glycerin • Isopropyl Alcohol • Lemon Oil • Triethanolamine • Tea Tree 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 DailyMedingredient 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
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/mLthis 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
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
Mar 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 MENTHOL, UNSPECIFIED FORM — the ingredient across all brands.

Top reported reactions

Pain74
Fatigue66
Diarrhoea58
Fall53
Headache51
Arthralgia48
Pain In Extremity45

Age at onset

Child3
Adolescent1
Adult44
Elderly62

Reporter sex

913 reports
Male · 26%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization186
Life-threatening11
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 97 32
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
75568-0043-00 You're viewing this 3 TUBE in 1 BOX (75568-043-00) / 118 mL in 1 TUBE 2026-03-31 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 75568-043-00, 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: 75568-0043-00, written without dashes as 75568004300. 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 75568-0043-00, the first segment (75568) is the labeler code FDA assigned to Planet (Anhui) Pharmaceutical Co.,Ltd; the middle segment (0043) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Planet (Anhui) Pharmaceutical Co.,Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Planet (Anhui) Pharmaceutical Co.,Ltd 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 20 words

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

⏱️ Dosage and Administration 21 words

Directions Rub a thin film over the affected area not more than 3 to 4 times daily. Wash hands after use.

⚠️ Warnings 217 words

Warnings • Please read all directions and warnings as follows and use only as directed. For external use only. • Flammable: Keep away from excessive heat or open flame. Do not heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns. • If pregnant or breast-feeding, ask a health professional before use. • Do not bandage tightly. • Avoid contact with the eyes. • Do not apply to wounds or damaged skin Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use • Alone if you are under the age of 12, please consult a doctor. • If you’re allergic to the listed ingredients. • If the package arrives damaged or opened. • at the same time as other topical analgesics. • on mucous membranes, cuts, broken, swollen, or irritated skin. Stop use and ask a doctor if • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. • if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering. • if the arthritic pain persists for more than 10 days, or redness is presen

🧪 Active Ingredient 7 words

Active Ingredient Menthol 4% Purpose Topical Analgesic

🧪 Inactive Ingredients 29 words

Inactive ingredients • Arnica Oil • Calendula Oil • Carbomer • Dimethyl Isosorbide • Glycerin • Isopropyl Alcohol • Lemon Oil • Triethanolamine • Tea Tree Oil • Water

🎯 Purpose 3 words

Purpose Topical Analgesic

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.