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NECK AND LUMBAR PAIN RELIEVING BALM CAMPHOR, MENTHOL, METHYL SALICYLATE 11 g/100g; 16 g/100g; 30 g/100g Ointment — NDC 55614-0661-01 package photo

NECK AND LUMBAR PAIN RELIEVING BALM CAMPHOR, MENTHOL, METHYL SALICYLATE 11 g/100g; 16 g/100g; 30 g/100g Ointment

by MADISON ONE ACME INC · 1 BOTTLE, GLASS in 1 BOX (55614-661-01) / 80 g in 1 BOTTLE, GLASS
NDC 55614-0661-01
🏷️ FDA NDC (as labeled) 55614-661-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 55614-661-01
Product NDC 55614-661
11-digit billing NDC 55614066101
RxCUI 2370911
UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Application # M017
SPL Set ID d06f0650-a5f6-4bc1-a70b-b0fc16968fa9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-05-21
Route TOPICAL
Dosage form OINTMENT
Substance CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Why two NDCs? The FDA registers this code as 55614-661-01 — 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 → 55614-0661-01. 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

LabelerMADISON ONE ACME INC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55614
First marketedMay 2020
Product typeHuman Otc Drug
Portfolio18 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?

This is an over-the-counter topical ointment marketed under FDA's established monograph guidelines for OTC products. It contains camphor, menthol, and methyl salicylate, which are rubefacients and counterirritants typically used in balms applied to the skin over areas of neck and lower back discomfort. These ingredients are commonly included in topical products to create a warming or cooling sensation on the skin surface. The ointment is intended for application directly to 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 B66F4574UG
    A plant-derived ingredient from Chinese angelica root, used as a natural flavoring and fragrance agent in medicines. It may also serve as a traditional ingredient to support formulation stability.
  • UNII 086263LQDD
    A natural extract from sappan wood, a tropical tree. Used as a colorant to give medicines their red or brown appearance.
  • UNII DQD16J2B5O
    A natural extract from bitter orange fruit used as a flavoring agent and fragrance component. It adds citrus taste and aroma to medicines, making them more palatable for patients.
  • UNII 5I0R0U8ZL0
    A natural mineral extract from oyster shells, primarily composed of calcium carbonate. Used in medicines as a filler to add bulk and as a buffering agent to neutralize stomach acid.
  • UNII BRM37UP34O
    A plant-derived ingredient from Cyathula officinalis root. It may be used as a binder or filler to help hold tablet ingredients together and add bulk to the formulation.
  • UNII LB1GQP4253
    A plant extract from the teasel root used as a traditional herbal ingredient. In medicines, it may function as a filler or binder to help hold the product together and maintain its form.
  • UNII M3YJ2C28IC
    Dragon's blood is a natural red resin obtained from tropical plants. It's used in medicines as a colorant and binding agent to give pills and capsules their appearance and help hold ingredients together.
  • UNII L878N1L0AR
    A plant extract from the bark of the eucommia tree, used in some formulations as a thickening or binding agent to help hold the medicine together and control how it dissolves.
  • UNII R9XLF1R1WM
    Frankincense is a natural resin from the Boswellia tree. It's used in medicines as a binder or thickener to help hold ingredients together and improve the product's consistency and texture.
  • UNII V315CCZ08Z
    A plant extract from Japanese motherwort used as a natural coloring agent or flavoring component in some formulations. It may also serve as a carrier or binder to help hold tablet ingredients together.
  • UNII RR83T99U97
    A plant-derived substance from Asian lovage root used in traditional formulations. It may serve as a flavoring agent, fragrance component, or natural additive to support product stability and palatability.
  • UNII JC71GJ1F3L
    Myrrh is a natural resin obtained from a tree, traditionally used in medicines and perfumes. It may serve as a flavoring agent, fragrance, or mild preservative in formulations.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII GQX1C1175U
    A plant extract from Panax notoginseng root used in traditional medicine formulations. It may function as a filler or active botanical component in herbal or dietary supplement products.
  • UNII 4V873H15CG
    A plant-derived natural colorant from the madder plant root. It provides red to brown coloring in medicines and may help bind ingredients together in tablet formulations.
  • UNII 4VBL71TY4Y
    Safflower is a plant-derived ingredient used as a natural colorant and flavoring agent in medicines. It may also serve as a filler to add bulk to the formulation.
  • UNII 1693AM5SBN
    Salvia miltiorrhiza root is a plant extract used in traditional medicine formulations. It may serve as a flavoring agent, natural colorant, or functional ingredient to support the product's intended therapeutic profile.
  • UNII CHL342Y4LA
    A natural extract from acacia wood, used as a binder and astringent in tablets and capsules to help hold ingredients together and improve texture.
  • UNII N51VZ363BA
    A plant extract derived from the stem of Spatholobus suberectus, a tropical vine. It's used in herbal and traditional medicine formulations as a natural ingredient to support the product's therapeutic properties and stability.
  • UNII QJ523LD71P
    A plant-derived ingredient from Taxillus chinensis, used as a filler or binder to help hold the medicine's solid form together and provide bulk.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesInactive ingredients angelica sinensis root, biancaea sappan wood, citrus aurantium fruit, crassostrea gigas shell, cyathula officinalis root, dipsacus asper root, dragon's blood, eucommia ulmoides bark, frankincense, leonurus japonicus flowering top, ligusticum sinense subsp. chuanxiong root, myrrh, olive oil, panax notoginseng root, rubia cordifolia root, safflower, salvia miltiorrhiza root, senegalia catechu wood, spatholobus suberectus stem, taxillus chinensis top and white wax.

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
Neck And Lumbar Pain Relieving Balm 11 g/100g; 16 g/100g; 30 g/100gthis 55614-0661-01 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
May 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.

🔬 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

Serious outcomes

Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 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
55614-0661-01 You're viewing this 1 BOTTLE, GLASS in 1 BOX (55614-661-01) / 80 g in 1 BOTTLE, GLASS 2020-05-21 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 55614-661-01, 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: 55614-0661-01, written without dashes as 55614066101. 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 55614-0661-01, the first segment (55614) is the labeler code FDA assigned to MADISON ONE ACME INC; the middle segment (0661) 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 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.

📄 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
🎯 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 ingredients Camphor 11% Menthol 16% Methyl salicylate 30%

🧪 Inactive Ingredients 60 words ▾

Inactive ingredients angelica sinensis root, biancaea sappan wood, citrus aurantium fruit, crassostrea gigas shell, cyathula officinalis root, dipsacus asper root, dragon's blood, eucommia ulmoides bark, frankincense, leonurus japonicus flowering top, ligusticum sinense subsp. chuanxiong root, myrrh, olive oil, panax notoginseng root, rubia cordifolia root, safflower, salvia miltiorrhiza root, senegalia catechu wood, spatholobus suberectus stem, taxillus chinensis top and white wax.

🎯 Purpose 7 words ▾

Purpose External analgesic External analgesic External analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55614-0650-01 · MADISON 55614-0670-01 · 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.