Home › NDC Lookup › Ingredients › Camphor Menthol Methyl Salicylate › 48201-0004-17
CALMADOL Camphor, Menthol, Methyl Salicylate 6 g/100g; 1.9 g/100g; 10 g/100g Liniment, 1 jar — NDC 48201-0004-17 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CALMADOL Camphor, Menthol, Methyl Salicylate 6 g/100g; 1.9 g/100g; 10 g/100g Liniment, 1 jar — NDC 48201-004-17 (Billing 48201-0004-17)

by GRANDALL DISTRIBUTING, LLC · 1 JAR in 1 BOX / 170.1 g in 1 JAR

This is a package of 1 jar of CALMADOL Camphor, Menthol, Methyl Salicylate 6 g/100g; 1.9 g/100g; 10 g/100g Liniment from GRANDALL DISTRIBUTING, LLC, marketed since Jul 2015 and currently FDA-listed. It is this product's only package size.

NDC 48201-0004-17
🏷️ FDA NDC (as labeled) 48201-004-17 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 48201-004-17 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
48201 labeler · 004 product · 17 package
Package marketed since
Jul 8, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0048201005479
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 48201-004-17
Product NDC 48201-004
11-digit billing NDC 48201000417
RxCUI 2688458
UNII N20HL7Q941, L7T10EIP3A, LAV5U5022Y
UPC 0048201005479
Application # M017
SPL Set ID 31b7f84e-8b66-4d31-8e9c-279d0af2fe64
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-08
Route TOPICAL
Dosage form LINIMENT
Substance CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE
Quick answers
  • RxCUI (RxNorm): 2688458
Why two NDCs? The FDA registers this code as 48201-004-17 — 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 → 48201-0004-17. 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

🧪 What is this product?

Calmadol is a topical liniment containing camphor, menthol, and methyl salicylate. These ingredients are commonly used in over-the-counter products to produce a warming or cooling sensation on the skin and are typically included in preparations intended for localized discomfort. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of topical analgesic products rather than undergoing individual application review.

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 eachPer 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
48201-0004-17 You're viewing this Main listing 1 JAR in 1 BOX / 170.1 g in 1 JAR 2015-07-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calmadol 6 g/100g; 1.9 g/100g; 10 g/100gthis 48201-0004-17 GRANDALL 1 jar — — 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII DIQ16UC154
    A surfactant derived from lauric acid that helps dissolve or disperse ingredients in liquid formulations. It may act as a detergent, emulsifier, or foaming agent to improve how the medicine mixes and is absorbed.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 XJ6RUH0O4G
    Turpentine is a volatile liquid derived from pine tree resin. It's used in medicines as a solvent and penetrating agent to help active ingredients dissolve and absorb into the skin or body.

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

The official label also statesPuified Water (Aqua), Stearic Acid, Glyceryl Stearate, Turpentine, Mentha Piperita (Pepperment) Oil, TEA-Lauryl Sulfate, Triethanolamine, Methylparaben, Propylparaben.

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

LabelerGRANDALL DISTRIBUTING, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code48201
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from GRANDALL DISTRIBUTING, LLC labeler code 48201

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

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

⏱️ Dosage and Administration 39 words ▾

Directions Use only as directed. Adults and chrldren older than 12 years of age, apply cream to the affected area not more than 3 to 4 trmes daily. For children less than 12 years of age: ask a doctor

⚠️ Warnings 80 words ▾

Warnings For external use only When using this product Avoid contact with eyes and mucous membranes Do not bandage tightly Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within few days. If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. Keep out of reach of childern.

If swallowed, get medical help or contact a Poison Control Center immediately.

🧪 Active Ingredient 9 words ▾

Active Ingredients: Camphor 6.00% Menthol 1.90% Methyl Salicylate 10.00%

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients Puified Water (Aqua), Stearic Acid, Glyceryl Stearate, Turpentine, Mentha Piperita (Pepperment) Oil, TEA-Lauryl Sulfate, Triethanolamine, Methylparaben, Propylparaben.

🎯 Purpose 3 words ▾

Purpose: External Analgesic

📄 Do Not Use 18 words ▾

Do not use on wounds on damaged skin with heating pad on children under 12 years of age

📄 When Using This Product 15 words ▾

When using this product Avoid contact with eyes and mucous membranes Do not bandage tightly

📄 Stop Use and Ask a Doctor If 26 words ▾

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

🤰 If Pregnant or Breast-Feeding 16 words ▾

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 10 words ▾

Package Labeling ARTHRITIS CALMADOL NET WT. 6 oz (170.1G) OintmentLabel

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 CALMADOL (this brand).

Top reported reactions

Abdominal Pain1
Anaemia1
Cauda Equina Syndrome1
Fibrosis1
Hernia1
Incorrect Storage Of Drug1
Pain1

Reporter sex

3 reports
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 GRANDALL DISTRIBUTING, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GRANDALL DISTRIBUTING, 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.
← 48201-0001-12 · GRANDALL 48201-0006-08 · GRANDALL →
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.