Home › NDC Lookup › Ingredients › Menthol › 82460-0345-00
SIMPLY VITAL PAIN RELIEF HEMP MENTHOL 80 mg/mL Cream, 120 mL — NDC 82460-0345-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SIMPLY VITAL PAIN RELIEF HEMP MENTHOL 80 mg/mL Cream, 120 mL — NDC 82460-345-00 (Billing 82460-0345-00)

by ALPHA PLANTS INC · 120 mL in 1 JAR

This is a package of 120 mL of SIMPLY VITAL PAIN RELIEF HEMP MENTHOL 80 mg/mL Cream from ALPHA PLANTS INC, marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.

NDC 82460-0345-00
🏷️ FDA NDC (as labeled) 82460-345-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 82460-345-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82460 labeler · 345 product · 00 package
Package marketed since
Aug 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8246034500 7
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) 82460-345-00
Product NDC 82460-345
11-digit billing NDC 82460034500
UNII L7T10EIP3A
Application # M017
SPL Set ID c14f4c06-cfe5-497e-9f9e-b2ba442e61bb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-01
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Why two NDCs? The FDA registers this code as 82460-345-00 — 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 → 82460-0345-00. 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.

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.
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
82460-0345-00 You're viewing this Main listing 120 mL in 1 JAR 2022-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PRFC HEMP Topical Analgesic 80 mg/mL 82543-0327-00 DOBEST 120 ml — — FDA listed —
AMP RELIEF Pain Relief Cream 80 mg/mL 82560-0273-00 COASTAL 118.29 ml — — FDA listed —
AMP RELIEF Pain Relief Cream 80 mg/mL 82560-0283-00 COASTAL 3939.19 ml — — FDA listed —
Simply Vital Pain Relief Hemp 80 mg/mLthis 82460-0345-00 ALPHA 120 ml — — FDA listed —
ActivICE 80 mg/mL 53329-0984-04 Medline 118 ml — — FDA listed —
Stopain Extra Strength Gel 80 mg/mL 63936-9506-01 Troy 118 ml — — FDA listed —
Stopain Extra Strength Gel 80 mg/mL 63936-8800-01 Troy 3785 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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 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.
  • UNII 69VJ1LPN1S
    Cannabis sativa seed oil is a plant-based oil derived from hemp seeds. It's used in medicines as a carrier or emollient to help deliver active ingredients and improve product texture and absorption.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 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.
  • 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.
  • 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.

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

The official label also statesAcrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

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

LabelerALPHA PLANTS INC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code82460
First marketedAug 2022
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from ALPHA PLANTS INC labeler code 82460

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 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 23 words ▾

Uses: For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains

⏱️ Dosage and Administration 31 words ▾

Directions: 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 doctor.

⚠️ Warnings 88 words ▾

Warnings: For external use only. Do not use: on damaged or brosken skin. When using this product Avoid contact with eyes.

Do not bandage tightly. Stop use and ask a doctor if Rash or irritation develops and lasts. 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 breastfeeding, ask a health professional before use.

🧪 Active Ingredient 7 words ▾

Active Ingredient Menthol 8.00% Purpose Topical Analgesic

🧪 Inactive Ingredients 33 words ▾

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

📄 Do Not Use 8 words ▾

Do not use: on damaged or brosken skin.

📄 When Using This Product 12 words ▾

When using this product Avoid contact with eyes. Do not bandage tightly.

📄 Stop Use and Ask a Doctor If 34 words ▾

Stop use and ask a doctor if Rash or irritation develops and lasts. Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, 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?: +1 (205) 624-9177

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label

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

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 — the ingredient across all brands.

Top reported reactions

Pain3,545
Fatigue3,324
Nausea3,269
Headache3,025
Dyspnoea2,472
Diarrhoea2,208
Pneumonia2,151

Age at onset

Neonate144
Infant64
Child375
Adolescent265
Adult5,396
Elderly3,493

Reporter sex

54,494 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization18,792
Death5,294
Life-threatening4,358
Disabling1,340
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,467 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.

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 ALPHA PLANTS INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ALPHA PLANTS 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.
← 82460-0344-00 · ALPHA 82460-0990-00 · Alpha →
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.