Home › NDC Lookup › Ingredients › Methyl Salicylate, Menthol, Capsaicin › 83538-0101-18
MED O-3 BIO- METHYL SALICYLATE, MENTHOL, CAPSAICIN 10 g/100mL; .03 g/100mL; 1 g/100mL Cream, 237 mL — NDC 83538-0101-18 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MED O-3 BIO- METHYL SALICYLATE, MENTHOL, CAPSAICIN 10 g/100mL; .03 g/100mL; 1 g/100mL Cream, 237 mL — NDC 83538-101-18 (Billing 83538-0101-18)

by Biological M.D. Solutions LLC · 237 mL in 1 BOTTLE

This is a package of 237 mL of MED O-3 BIO- METHYL SALICYLATE, MENTHOL, CAPSAICIN 10 g/100mL; .03 g/100mL; 1 g/100mL Cream from Biological M.D. Solutions LLC, marketed since Aug 2023 and currently FDA-listed. It is this product's only package size.

NDC 83538-0101-18
🏷️ FDA NDC (as labeled) 83538-101-18 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 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

NDC database record

One package, one record: these facts belong to NDC 83538-101-18 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83538 labeler · 101 product · 18 package
Package marketed since
Aug 8, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8353810118 1
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83538-101-18
Product NDC 83538-101
11-digit billing NDC 83538010118
RxCUI 2644111
UNII LAV5U5022Y, S07O44R1ZM, L7T10EIP3A
Application # M017
SPL Set ID 02707552-03d9-3ad2-e063-6294a90a3472
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-08
Route TOPICAL
Dosage form CREAM
Substance METHYL SALICYLATE; CAPSAICIN; MENTHOL
Quick answers
  • RxCUI (RxNorm): 2644111
Why two NDCs? The FDA registers this code as 83538-101-18 — 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 → 83538-0101-18. 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.

RxNorm drug class

This medicine belongs to the Capsaicin and similar agents class.

Drug family (ATC) Capsaicin and similar agents, Other local anesthetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

MED O-3 BIO is a topical cream containing three active ingredients commonly used in over-the-counter pain-relief products. Methyl salicylate and menthol are typically applied to the skin to produce a warming or cooling sensation and may help reduce minor muscle and joint discomfort. Capsaicin, derived from chili peppers, is also commonly included in topical creams for similar purposes. This is an OTC monograph drug, meaning it is marketed under FDA's established rules for this product category.

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
83538-0101-18 You're viewing this Main listing 237 mL in 1 BOTTLE 2023-08-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Med O-3 Bio- 10 g/100mL; .03 g/100mL; 1 g/100mLthis 83538-0101-18 Biological 237 ml — — FDA listed —
Oprava 10 g/100mL; .03 g/100mL; 1 g/100mL 83538-0102-18 Biological 237 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
Aug 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerBiological M.D. Solutions LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code83538
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Biological M.D. Solutions LLC labeler code 83538

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

USES FAST ACTING DEEP PENETRATING HOURS OF RELIEF FOR ARTHRITIS BACKACHE MUSCLE ACHE JOINT PAIN SPRAINS SPORTS INJURIES TENDON INFLAMMATION OVER-USE INJURIES

⏱️ Dosage and Administration 26 words ▾

DIRECTIONS APPLY GENEROUSLY. GENTLY MASSAGE INTO PAINFUL AREA UNTIL THOROUGHLY ABSORBED. REPEAT AS NECESSARY, UP TO FOUR TIMES DAILY. PRODUCT CAN BE USED WITH A WRAP.

⚠️ Warnings 52 words ▾

WARNINGS FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, MUCOUS MEMBRANES AND BROKEN OR IRRITATED SKIN. IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR IF REDNESS IS PRESENT, DISCONTINUE USE AND CONSULT A PHYSICIAN. FOR TEMPORARY RELIEF. NOT FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.

📦 Storage and Handling 11 words ▾

STORE AT CONTROLLED ROOM TEMPERATURE. 59° - 86°F (15° - 30°C).

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENTS METHYL SALICYLATE 10% MENTHOL 1% CAPSAICIN 0.03%

🧪 Inactive Ingredients 56 words ▾

INACTIVE INGREDIENTS ALOE BARBADENSIS LEAF JUICE, BORAGE OIL, CARBOMER, CETEARYL ALCOHOL, CETYL ALCOHOL, DEIONIZED WATER, EUCALYPTUS GLOBULUS LEAF OIL, FRUCTOSE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, METHYL PARABEN, OLEA EUROPAEA (OLIVE) FRUIT OIL, PHENOXYETHANOL, POLYSORBATE-60, PROPYL PARABEN, PROPYLENE GLYCOL, SALMON OIL, SODIUM HYDROXIDE, SQUALANE, STEARYL ALCOHOL, STEARIC ACID, TETRASODIUM EDTA, TOCOPHEROL, TOCOPHERYL ACETATE, VITIS VINIFERA (GRAPE) SEED OIL

🎯 Purpose 3 words ▾

PURPOSE TOPICAL ANALGESIC

📄 Keep Out of Reach of Children 22 words ▾

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY. USE ONLY AS DIRECTED.

📄 Questions or Comments 5 words ▾

QUESTIONS? EMAIL US AT [email protected]

📄 Package Label / Principal Display Panel 4 words ▾

01b LBL_Med 0-3 Bio-Cream_237mL

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 METHYL SALICYLATE, MENTHOL, CAPSAICIN — the ingredient across all brands.

Top reported reactions

Headache4
Blood Pressure Increased3
Chest Pain3
Depression3
Diarrhoea3
Fatigue3
Hypersensitivity3

Age at onset

Adult5

Reporter sex

39 reports
Male · 29%
Female · 69%
Unknown · 3%

Serious outcomes

Hospitalization10
Life-threatening2
Death1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 3 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Biological M.D. Solutions LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Biological M.D. Solutions 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.
← 83537-0034-01 · Rocket 83538-0102-18 · Biological →
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.