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JOSEPHS LION PAIN RELIEVING Camphor, Menthol, Methyl Salicylate 5 g/100mL; 8 g/100mL; 10 g/100mL Oil — NDC 55614-0680-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

JOSEPHS LION PAIN RELIEVING Camphor, Menthol, Methyl Salicylate 5 g/100mL; 8 g/100mL; 10 g/100mL Oil — NDC 55614-680-01 (Billing 55614-0680-01)

by MADISON ONE ACME INC · 1 BOTTLE, GLASS in 1 BOX / 50 mL in 1 BOTTLE, GLASS

This is a package of JOSEPHS LION PAIN RELIEVING Camphor, Menthol, Methyl Salicylate 5 g/100mL; 8 g/100mL; 10 g/100mL Oil from MADISON ONE ACME INC, marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 55614-0680-01
🏷️ FDA NDC (as labeled) 55614-680-01 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 55614-680-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55614 labeler · 680 product · 01 package
Package marketed since
Jun 4, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5561468001 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55614-680-01
Product NDC 55614-680
11-digit billing NDC 55614068001
RxCUI 2372438
UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Application # M017
SPL Set ID 69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-04
Route TOPICAL
Dosage form OIL
Substance CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Quick answers
  • RxCUI (RxNorm): 2372438
Why two NDCs? The FDA registers this code as 55614-680-01 — 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 → 55614-0680-01. 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.

Clinical

🧪 What is this product?

Joseph's Lion Pain Relieving Oil is a topical OIL product marketed as an over-the-counter monograph drug. It contains camphor, menthol, and methyl salicylate, three ingredients commonly used together in topical pain-relief products. These substances are typically applied to skin to produce a warming or cooling sensation and are used as counterirritants for minor muscle and joint discomfort. This is an OTC monograph product, meaning it is made according to FDA category rules rather than through individual product approval.

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
55614-0680-01 You're viewing this Main listing 1 BOTTLE, GLASS in 1 BOX / 50 mL in 1 BOTTLE, GLASS 2020-06-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Josephs Lion Pain Relieving 5 g/100mL; 8 g/100mL; 10 g/100mLthis 55614-0680-01 MADISON 1 bottle — — 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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 6Y89129C8H
    Anise oil is a natural flavoring extract from anise seeds. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII J3TO6BUQ37
    Cajuput oil is a fragrant essential oil extracted from the cajuput tree. It's used in medicines as a flavoring agent and to add aroma, and may help mask unpleasant tastes.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.

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

The official label also statesInactive ingredients Anise oil, cajuput oil, lavender oil and mineral oil.

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

LabelerMADISON ONE ACME INC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55614
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from MADISON ONE ACME INC labeler code 55614

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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

⏱️ Dosage and Administration 38 words ▾

Directions ■ adults and children 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily ■ children under 3 years of age: consult your physician

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 16 words ▾

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

📦 Storage and Handling 21 words ▾

Other information ■ keep container tightly closed ■ store protected from light at 15 to 30 C (59 to 86 F)

🧪 Active Ingredient 9 words ▾

Active ingredient Camphor 5% Menthol 8% Methyl salicylate 10%

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Anise oil, cajuput oil, lavender oil and mineral oil.

🎯 Purpose 7 words ▾

Purpose External analgesic External analgesic External analgesic

📄 Do Not Use 12 words ▾

Do not use ■ on irritated or damaged skin ■ on wounds

📄 Ask a Doctor or Pharmacist Before Use If 17 words ▾

Ask a doctor or pharmacist before use if you have ■ any concerns about using this product

📄 When Using This Product 53 words ▾

When using this product ■ do not use otherwise than as directed ■ avoid contact with the eyes or mucous membranes ■ do not bandage tightly ■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

📄 Stop Use and Ask a Doctor If 97 words ▾

Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive irritation of the skin develops ■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) ■ when using for pain of arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age

📄 Keep Out of Reach of Children 23 words ▾

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

📄 Questions or Comments 23 words ▾

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm ■ you may also report serious side effects to this phone number

📄 Package Label / Principal Display Panel 16 words ▾

JOSEPH’S LION PAIN RELIEVING OIL NDC-55614-680-01 EXTERNAL ANALGESIC

1.69 FL OZ (50 ML) IMAGE OF CARTON

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 Camphor, Menthol, Methyl Salicylate — the ingredient across all brands.

Top reported reactions

Application Site Burn6
Application Site Pain6
Chemical Injury4
Erythema3
Malaise3
Pain3
Rash3

Age at onset

Adult1

Reporter sex

49 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization9
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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 MADISON ONE ACME INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MADISON ONE ACME 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.
← 55614-0671-01 · MADISON 55614-0690-01 · MADISON →
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.