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Original Pain-A-Trate Pain-Relieving Cream Camphor and Menthol and Methyl Salicylate 32.5 mg/g; 15 mg/g; 150 mg/g Cream, 85 g — NDC 54473-0335-03 package photo

Original Pain-A-Trate Pain-Relieving Cream Camphor and Menthol and Methyl Salicylate 32.5 mg/g; 15 mg/g; 150 mg/g Cream, 85 g

by Melaleuca, Inc. · 85 g in 1 TUBE (54473-335-03)
NDC 54473-0335-03
🏷️ FDA NDC (as labeled) 54473-335-03 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) 54473-335-03
Product NDC 54473-335
11-digit billing NDC 54473033503
RxCUI 1091381
UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Application # 505G(a)(3)
SPL Set ID cf6daad3-204e-aff3-e053-2995a90adb94
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-01
Route TOPICAL
Dosage form CREAM
Substance CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Why two NDCs? The FDA registers this code as 54473-335-03 — 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 → 54473-0335-03. 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

LabelerMelaleuca, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code54473
First marketedOct 2021
Product typeHuman Otc Drug
Portfolio22 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?

Original Pain-A-Trate is a topical cream marketed as an over-the-counter monograph product. It contains camphor, menthol, and methyl salicylate, which are commonly used in pain-relief creams applied to the skin. These ingredients are typically chosen for their warming or cooling sensations and their traditional use in topical products intended to address minor aches and discomfort in muscles and joints.

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 575DY8C1ER
    Aloe vera flower is a natural plant extract used in medicines as a skin-soothing agent and emollient. It helps soften and moisturize formulations, particularly in topical products like creams and lotions.
  • UNII 3TE8A92UPM
    Azadirachta indica flower is a botanical extract from the neem plant. It may be used in formulations for its traditional preservative or antioxidant properties to help maintain product stability.
  • UNII HKY915780T
    A plant extract from the neem tree, used as a natural flavoring agent and preservative in medicines. It may help maintain product stability and add bitter taste characteristics.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII VLJ6WOT3K5
    A plant extract from the Coccinia indica fruit, used in herbal and traditional formulations. It may serve as a natural flavoring agent, colorant, or active botanical component depending on the product's intended use.
  • UNII 4004498D06
    A red algae extract used as a natural colorant and pH buffer in medicines. It provides reddish tones to tablets and capsules while helping maintain stable acidity levels in the formulation.
  • UNII W5488JUO8U
    A plant extract from turmeric root used as a natural colorant and flavoring agent in medicines. It provides yellow-to-orange color and mild spice flavor to tablets, capsules, and liquids.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 7SAB275FP2
    A plant extract made from basil flowers and leaves. It's used in medicines as a flavoring agent and may help preserve the product by providing natural antimicrobial properties.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII VAC44EX123
    A green pigment derived from chlorophyll that binds to copper. It's used as a colorant and may help reduce odors in formulations.
  • UNII 5DS5EE0N93
    Solanum melongena whole is eggplant, a plant-derived ingredient. It may serve as a natural filler, colorant, or source of plant material in formulations.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • 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 VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesInactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis flower extract, benzyl alcohol, cetyl alcohol, chlorophyllin-copper complex, coccinia indica fruit extract, corallina officianalis extract, curcuma longa (turmeric) root extract, ethylhexylglyverin, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta flower extract, melia azadirachta leaf extract, ocimum basilicum (basil) flower/leaf extract, ocimum sanctum (holy basil) leaf extract, polysorbate 20, solanum melongena (eggplant) fruit extract, sorbitan stearate, stearic acid, triethanolamine, water

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
Original Pain-A-Trate Pain-Relieving Cream 32.5 mg/g; 15 mg/g; 150 mg/gthis 54473-0335-03 Melaleuca, 85 g — — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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 Original Pain-A-Trate Pain-Relieving Cream (this brand).

Top reported reactions

Femur Fracture1
Stress Fracture1

Reporter sex

1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
54473-0335-03 You're viewing this 85 g in 1 TUBE (54473-335-03) 2021-10-01 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 54473-335-03, 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: 54473-0335-03, written without dashes as 54473033503. 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 54473-0335-03, the first segment (54473) is the labeler code FDA assigned to Melaleuca, Inc.; the middle segment (0335) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Melaleuca, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Melaleuca, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 words ▾

Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains. Provides penetrating pain relief.

⏱️ Dosage and Administration 18 words ▾

Directions apply to affected area with gentle massage do not apply more than 3 to 4 times daily

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 8 words ▾

Other information do not store above 95°F (35°C)

🧪 Active Ingredient 9 words ▾

Active ingredients Camphor 3.25% Menthol, 1.5% Methyl Salicylate, 15%

🧪 Inactive Ingredients 70 words ▾

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis flower extract, benzyl alcohol, cetyl alcohol, chlorophyllin-copper complex, coccinia indica fruit extract, corallina officianalis extract, curcuma longa (turmeric) root extract, ethylhexylglyverin, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta flower extract, melia azadirachta leaf extract, ocimum basilicum (basil) flower/leaf extract, ocimum sanctum (holy basil) leaf extract, polysorbate 20, solanum melongena (eggplant) fruit extract, sorbitan stearate, stearic acid, triethanolamine, water

🎯 Purpose 3 words ▾

Purpose Topical analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54473-0334-03 · Melaleuca, 54473-0336-01 · Melaleuca, →
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.