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EXTRA STRENGTH HUA TUO PAIN RELIEF CAMPHOR AND MENTHOL 3.1 g/100g; 2.6 g/100g Patch, 6 patches — NDC 55614-0630-01 package photo

EXTRA STRENGTH HUA TUO PAIN RELIEF CAMPHOR AND MENTHOL 3.1 g/100g; 2.6 g/100g Patch, 6 patches

by MADISON ONE ACME INC · 1 POUCH in 1 BOX (55614-630-01) / 6 PATCH in 1 POUCH / 1 g in 1 PATCH
NDC 55614-0630-01
🏷️ FDA NDC (as labeled) 55614-630-01 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) 55614-630-01
Product NDC 55614-630
11-digit billing NDC 55614063001
RxCUI 2118540
UNII 5TJD82A1ET, L7T10EIP3A
Application # M017
SPL Set ID 0f269a41-4b56-4e22-b9cb-17d99bf76a57
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-01
Route TRANSDERMAL
Dosage form PATCH
Substance CAMPHOR (SYNTHETIC); MENTHOL
Why two NDCs? The FDA registers this code as 55614-630-01 — 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 → 55614-0630-01. 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 marketedApr 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 transdermal patch sold under FDA's OTC monograph rules for topical pain relief. The patch contains camphor and menthol as active ingredients, which are typically used in external pain-relief products for their warming and cooling sensations. Camphor and menthol are commonly applied to the skin to help soothe minor muscle and joint aches associated with conditions like arthritis and strains. The patch delivers these ingredients directly through the skin at the site of discomfort.

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 1V63N2S972
    A plant extract from angelica dahurica root used in traditional formulations. It may function as a flavoring agent, fragrance component, or natural ingredient to add therapeutic appeal to the medicine.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII E5GY4I6YCZ
    A fragrant liquid extracted from cinnamon bark, used as a flavoring agent to improve the taste of medicines and make them more pleasant to take.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII 2LQ0UUW8IN
    A natural rubber material derived from the rubber tree. It's used as a coating or component in capsule shells and drug delivery devices to provide structure, flexibility, and controlled release of the medication.
  • UNII 2FN3BA1MZE
    Nepeta tenuifolia flowering top is a plant extract used in herbal formulations. It may serve as a flavoring agent, natural color, or botanical active support ingredient in the product.
  • UNII AVG2506KDV
    A plant-derived oil extracted from holy basil leaves, used as a flavoring agent and fragrance component to improve the taste and aroma of the medicine.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 88S87KL877
    Rosin is a sticky resin extracted from pine trees. It's used in medicines as a binder and adhesive to help hold tablet ingredients together and improve how the medicine sticks to surfaces.
  • 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 8H84LFK2QD
    A plant root extract used in traditional herbal preparations. It serves as an active botanical ingredient that may provide flavor and natural properties to the formulation.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesInactive ingredients Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extra Strength Hua Tuo Pain Relief 3.1 g/100g; 2.6 g/100gthis 55614-0630-01 MADISON 6 patches — — FDA listed —
E Mei Shan Medicated 31 mg/1; 26 mg 55614-0730-01 MADISON 1 pouch — — FDA listed —
E Mei Shan Medicated 31 mg/1; 26 mg 69070-0300-01 Zhejiang 1 pouch — — FDA listed —
Tong Feng Ding Pain Relief 3.1 g/100g; 2.6 g/100g 69070-0301-01 Zhejiang 10 patches — — FDA listed —
Extra Strength Hua Tuo Pain Relieving 3.1 g/100g; 2.6 g/100g 69070-0307-01 Zhejiang 5 patches — — 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
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55614-0630-01 You're viewing this 1 POUCH in 1 BOX (55614-630-01) / 6 PATCH in 1 POUCH / 1 g in 1 PATCH 2020-04-01 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 55614-630-01, 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: 55614-0630-01, written without dashes as 55614063001. 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 55614-0630-01, the first segment (55614) is the labeler code FDA assigned to MADISON ONE ACME INC; the middle segment (0630) 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 40 words ▾

Directions ■ adults and children 2 years of age and older: remove the protective film from the patch. Apply to affected area not more than 3 to 4 times daily. ■ children under 2 years of age: consult your physician

⚠️ Warnings 18 words ▾

Warnings For external use only Allergy alert: This product contains natural rubber latex which may cause allergic reactions.

🤒 Adverse Reactions 16 words ▾

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

📦 Storage and Handling 29 words ▾

Other information ■ keep patches tightly closed in the zip-lock pouch ■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

🧪 Active Ingredient 6 words ▾

Active Ingredients Camphor 3.1% Menthol 2.6%

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.

🎯 Purpose 5 words ▾

Purpose External Analgesic External Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55614-0620-01 · MADISON 55614-0641-01 · 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.