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Pain Be Gone Menthol 9.6 mg/mL Cream, 120 mL — NDC 82721-0001-02 package photo

Pain Be Gone Menthol 9.6 mg/mL Cream, 120 mL

by Back to Earth Inc. · 120 mL in 1 TUBE (82721-001-02)
NDC 82721-0001-02
🏷️ FDA NDC (as labeled) 82721-001-02 billing pads the product segment with a zero
This package
Contains120 mL Pack sizes2 compare ↓
Also comes in: 50 ml 82721-0001-01
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 →

This page is curated, coded, and maintained by

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

⚠️
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

FDA NDC (as labeled) 82721-001-02
Product NDC 82721-001
11-digit billing NDC 82721000102
UNII L7T10EIP3A
Application # M014
SPL Set ID f49e718b-ef89-b648-e053-2a95a90a96c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-27
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Why two NDCs? The FDA registers this code as 82721-001-02 — 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 → 82721-0001-02. 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

LabelerBack to Earth Inc.
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code82721
First marketedJul 2023
Product typeHuman Otc Drug
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 →

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 O80TY208ZW
    Arnica montana is a plant extract used in some formulations as a flavoring agent or traditional botanical ingredient. It may contribute mild taste or aroma to the product.
  • UNII 26P3H26Z9X
    A volatile oil extracted from camphor trees, used as a fragrance and flavoring agent in medicines. It may also provide a cooling or soothing sensation in topical products.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 0HNC1J1YED
    A natural oil extracted from lemon fruit, used as a flavoring agent to mask bitter tastes and add pleasant citrus flavor to medicines. It also helps improve the overall taste of the product.
  • 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.
  • UNII 2125M16OWN
    A natural plant extract from wintergreen leaves, used as a flavoring agent to add taste to medications and improve how they feel in the mouth.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 79M2M2UDA9
    Mentha piperita is peppermint, a plant extract used in medicines as a flavoring agent and to provide a cooling or soothing taste. It helps make the medication more pleasant to take.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII 5EXL5H740Y
    A natural oil extracted from Scotch pine needles, used as a flavoring agent and fragrance component in medicines. It adds taste and aroma to improve how the medication tastes or smells.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII OXN0D3N28L
    A plant oil derived from rosemary flowering tops used as a flavoring agent and preservative in medicines. It adds aroma and may help protect the product from spoilage.
  • 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.

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

The official label also statesPurified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin, Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens (Wintergreen) Oil, Cinnamomum Camphora (White) Oil, Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.

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.
Try another pack size: 50 ml
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
Pain Be Gone 9.6 mg/mLthis 82721-0001-02 Back 120 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 Pain Be Gone (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

989 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization333
Death125
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 96 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
82721-0001-01 50 mL in 1 TUBE (82721-001-01) 2023-07-27 Active
82721-0001-02 You're viewing this 120 mL in 1 TUBE (82721-001-02) 2023-07-27 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 82721-0001-02?
NDC 82721-0001-02 contains 120 mL — 120 ml in 1 tube.
What is the difference between NDC 82721-0001-02 and NDC 82721-0001-01?
Both are Pain Be Gone Menthol 9.6 mg/mL Cream — the drug itself is identical. NDC 82721-0001-02 is the 120 mL package, while NDC 82721-0001-01 is the 50 ml package.
What NDC number is used to bill for this package of Pain Be Gone Menthol 9.6 mg/mL Cream?
Bill NDC 82721-0001-02 — the 11-digit billing format is 82721000102. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 82721-001-02, 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: 82721-0001-02, written without dashes as 82721000102. 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 82721-0001-02, the first segment (82721) is the labeler code FDA assigned to Back to Earth Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Back to Earth Inc.. 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 50 ml (82721-0001-01). 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?
Back to Earth Inc. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 27 words ▾

■ For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. For penetrating pain relief.

⏱️ Dosage and Administration 32 words ▾

■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. ■ Children under 2 years of age: consult a Physician/Doctor

⚠️ Warnings 78 words ▾

■ For external use only. ■ Avoid Contact with the eyes. If conditions worsen, or if symptoms persist for more that 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician/doctor. ■ Do not apply to wounds or damaged skin. ■ Do not bandage tightly. ■ Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active Ingredients Menthol 9.6%

🧪 Inactive Ingredients 46 words ▾

Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin, Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens (Wintergreen) Oil, Cinnamomum Camphora (White) Oil, Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.

🎯 Purpose 3 words ▾

Pain Relieving Gel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82718-2210-01 · SofTap 82723-0001-01 · Aopline →
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.