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AleveX camphor and menthol 16 mg/g; 5.5 mg/g Lotion — NDC 00280-0050-01 package photo

AleveX camphor and menthol 16 mg/g; 5.5 mg/g Lotion

by Bayer HealthCare LLC · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0280-0050-01) / 72 g in 1 BOTTLE, WITH APPLICATOR
NDC 00280-0050-01
🏷️ FDA NDC (as labeled) 0280-0050-01 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 0280-0050-01
Product NDC 0280-0050
11-digit billing NDC 00280005001
UNII L7T10EIP3A, 5TJD82A1ET
Application # M017
SPL Set ID bc66bc1b-c0d5-2481-e053-2a95a90a75de
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-01
Route TOPICAL
Dosage form LOTION
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Why two NDCs? The FDA registers this code as 0280-0050-01 — a 4-4-2 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 labeler segment → 00280-0050-01. 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

LabelerBayer HealthCare LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedApr 2021
Product typeHuman Otc Drug
Portfolio27 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

🧪 What is this product?

AleveX camphor and menthol lotion is a topical over-the-counter product marketed under FDA's monograph rules for topical pain-relief products. The lotion contains camphor and menthol as active ingredients, which are typically used to produce a cooling or warming sensation on the skin and are commonly found in products designed to temporarily soothe minor muscle aches and joint discomfort. This product is applied directly to the skin over the affected area.

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.

🧪 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 KD6TZ2QICH
    A synthetic humectant and skin-conditioning agent derived from menthol. It's used in topical formulations to help retain moisture, improve texture, and enhance the feel of the product on skin.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 67ZYA5T02K
    Frankincense oil is a natural aromatic extract from tree resin. In medicines, it's used as a fragrance and flavoring agent to improve taste and smell, and may also help preserve the product.
  • 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 3TH92O3BXN
    Isopulegol is a natural compound derived from peppermint and other plant oils. It functions as a flavoring agent and fragrance ingredient to improve the taste or smell of the medication.
  • UNII 84XB4DV00W
    Linseed oil is a plant-based oil extracted from flax seeds. It's used in medicines as an emollient and lubricant to improve texture and help with ingredient mixing in formulations.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII 9NP0832457
    A natural essential oil from the flowering parts of the mastich thyme plant. It serves as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII S2ULN37C9R
    A synthetic chemical compound derived from vanillin that acts as a flavoring agent and fragrance enhancer in medicines. It provides vanilla-like taste and aroma to improve the palatability of oral medications.
  • 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.

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

The official label also statesaminomethyl propanol, boswellia carterii oil, carbomer interpolymer, clove oil, edetate disodium, eucalyptus oil, fragrance, glycerin, isopulegol, linseed oil, menthoxypropanediol, pentylene glycol, peppermint oil, polysorbate 80, purified water, rosemary oil, SD alcohol 40-B (20.9% v/v), sorbitan monooleate, thymus mastichina flower, tocopherol, vanillyl butyl ether

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.
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
AleveX 16 mg/g; 5.5 mg/gthis 00280-0050-01 Bayer 1 bottle — — FDA listed —
AleveX 5.5 mg/g; 16 mg/g 00280-0063-01 Bayer 77 g — — FDA listed —
Meijer Pain Relieving analgesic 55 mg/g; 160 mg/g 79481-0051-01 Meijer 77 g — — 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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 AleveX (this brand).

Top reported reactions

Choking4
Dyspnoea4
Abdominal Discomfort3
Application Site Pain3
Nausea3
Application Site Pruritus2
Dyspepsia2

Age at onset

Adult5
Elderly8

Reporter sex

29 reports
Male · 24%
Female · 76%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 12 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
00280-0050-01 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0280-0050-01) / 72 g in 1 BOTTLE, WITH APPLICATOR 2021-04-01 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 ✓ 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 0280-0050-01, 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: 00280-0050-01, written without dashes as 00280005001. 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 00280-0050-01, the first segment (00280) is the labeler code FDA assigned to Bayer HealthCare LLC; the middle segment (0050) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Bayer HealthCare LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer HealthCare LLC 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 26 words ▾

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

⏱️ Dosage and Administration 46 words ▾

Directions Adults and children 12 years of age and older Apply to affected area not more than 3 to 4 times daily Wash hands with soap and water after use if product comes in contact with hands Children under 12 years of age Ask a doctor

⚠️ Warnings 144 words ▾

Warnings For external use only Flammable: Keep away from fire or flame. Do not use if you have ever had an allergic reaction to this product or any of its ingredients When using this product avoid contact with the eyes and mucous membranes do not bandage tightly do not use with a heating pad, medicated patch or other types of local heat do not apply to wounds or damaged, broken or irritated skin Stop use condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops where product was applied symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active ingredients Camphor 5.5% Menthol 16%

🧪 Inactive Ingredients 46 words ▾

Inactive ingredients aminomethyl propanol, boswellia carterii oil, carbomer interpolymer, clove oil, edetate disodium, eucalyptus oil, fragrance, glycerin, isopulegol, linseed oil, menthoxypropanediol, pentylene glycol, peppermint oil, polysorbate 80, purified water, rosemary oil, SD alcohol 40-B (20.9 % v/v), sorbitan monooleate, thymus mastichina flower, tocopherol, vanillyl butyl ether

🎯 Purpose 4 words ▾

Purpose Pain Relieving Lotion

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00280-0049-01 · Bayer 00280-0051-01 · Bayer →
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.