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Zepol Topical Analgesic Camphor, Menthol 6.55 g/100g; 6.55 g/100g Ointment, 30 g — NDC 55715-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zepol Topical Analgesic Camphor, Menthol 6.55 g/100g; 6.55 g/100g Ointment, 30 g — NDC 55715-001-01 (Billing 55715-0001-01)

by Laboratorios Zepol S.A. · 30 g in 1 TUBE

This is a package of 30 g of Zepol Topical Analgesic Camphor, Menthol 6.55 g/100g; 6.55 g/100g Ointment from Laboratorios Zepol S.A., marketed since Oct 2009 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 55715-0001-01
🏷️ FDA NDC (as labeled) 55715-001-01 billing pads the product segment with a zero
This package
Contains30 g Pack sizes3 compare ↓
Main listing for product 55715-001 · Also comes in: 90 g 55715-001-90 12 cans 55715-001-12
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 55715-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55715 labeler · 001 product · 01 package
Package marketed since
Oct 5, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0735549000135, 0735549000104, 0735549000111
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55715-001-01
Product NDC 55715-001
11-digit billing NDC 55715000101
RxCUI 1044238
UNII 5TJD82A1ET, L7T10EIP3A
UPC 0735549000135, 0735549000104, 0735549000111
Application # M017
SPL Set ID ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-10-05
Route TOPICAL
Dosage form OINTMENT
Substance CAMPHOR (SYNTHETIC); MENTHOL
Quick answers
  • RxCUI (RxNorm): 1044238
Why two NDCs? The FDA registers this code as 55715-001-01 — 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 → 55715-0001-01. 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?

Zepol Topical Analgesic is an over-the-counter ointment applied directly to the skin. It contains camphor and menthol, two topical ingredients commonly used together in pain-relief products. These substances are typically used to produce a cooling or warming sensation on the skin, which may help relieve minor muscle aches and joint discomfort. This product is marketed under the FDA's over-the-counter monograph rules for topical analgesics.

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 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.
Try another pack size: 90 g 12 cans
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
55715-0001-01 You're viewing this Main listing 30 g in 1 TUBE 2009-10-05 — Active
55715-0001-12 55715-001-12 12 CAN in 1 BOX / 10 g in 1 CAN 2019-10-01 — Active
55715-0001-90 55715-001-90 1 TUBE in 1 BOX / 90 g in 1 TUBE 2009-10-05 — Active

Pack size FAQ

What quantity is in this package?
This package contains 30 g — 30 g in 1 tube.
What NDC number is used to bill for this package of Zepol Topical Analgesic Camphor, Menthol 6.55 g/100g; 6.55 g/100g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zepol Topical Analgesic 6.55 g/100g; 6.55 g/100gthis 55715-0001-01 Laboratorios 30 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

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 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 RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • 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 2UK410MY6B
    Thyme oil is an essential oil extracted from the thyme plant. It's used in medicines as a flavoring agent and preservative to improve taste and help maintain product stability.
  • 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.

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

The official label also statesEucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.

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

LabelerLaboratorios Zepol S.A.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55715
First marketedOct 2009
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Laboratorios Zepol S.A. labeler code 55715

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, strains, bruises and sprains.

⏱️ Dosage and Administration 31 words ▾

Directions: -Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. -Children under 2 years of age: Consult a physician.

⚠️ Warnings 70 words ▾

Warnings For external use only. Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Do not apply to wounds or damaged skin. Do not bandage tightly. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

📦 Storage and Handling 10 words ▾

Other information Store at 30 degrees C (86 degrees F).

🧪 Active Ingredient 9 words ▾

Active Ingredients Camphor 6.55% Menthol 6.55% Purpose Topical Analgesic

🧪 Inactive Ingredients 9 words ▾

Inactive Ingredients Eucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

📄 Do Not Use 12 words ▾

Do not apply to wounds or damaged skin. Do not bandage tightly.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

📄 Package Label / Principal Display Panel 84 words ▾

Zepol Topical Analgesic 1 oz

Zepol Topical Analgesic Outer Box

Package Labeling: Outer Package Inner Package

Package Labeling: Outer Package2 Inner Package2

Zepol Topical Analgesic Ointment,12 units (0.35oz/10g) (55715-001-12) Label Label1 Label2

Zepol Topical Analgesic Ointment Box NDC 55715-001-12 Ointment ZEPOL Topical Analgesic The original Long-Lasting For relief from cold-related discomfort412 units 0.35oz (10g) Manufactured by Laboratorios Zepol, S.A. P.O. Box 3399-100 San José, Costa Rica. Made in Costa Rica. IN COSTA RICA CALL FOR FREE 800-937-6572 (800-ZEPOLSA) Regional Customer Service: [email protected] www.zepolab.com ZUA

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 Zepol Topical Analgesic (this brand).

Top reported reactions

Peripheral Motor Neuropathy2
Agitation1
Drug Abuse1
Dry Mouth1
Dyspnoea1
International Normalised Ratio Increased1
Multiple Organ Dysfunction Syndrome1

Age at onset

Adult1

Reporter sex

8 reports
Male · 63%
Female · 38%

Serious outcomes

Hospitalization4
Death1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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 Laboratorios Zepol S.A.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (55715-0001-90), 12 cans (55715-0001-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Laboratorios Zepol S.A. 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.
← 55714-9028-01 · Newton 55715-0002-02 · Laboratorios →
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.