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Pain Relieving Cream Analgesic Menthol, Unspecified Form and Methyl Salicylate 1 mg/100g; 2-ETHYLBUTYRATE 1.5 mg/100g Cream, 453.6 g — NDC 67385-0701-02 package photo

Pain Relieving Cream Analgesic Menthol, Unspecified Form and Methyl Salicylate 1 mg/100g; 2-ETHYLBUTYRATE 1.5 mg/100g Cream, 453.6 g

by Garcoa, Inc. · 453.6 g in 1 JAR (67385-701-02)
NDC 67385-0701-02
🏷️ FDA NDC (as labeled) 67385-701-02 billing pads the product segment with a zero
This package
Contains453.6 g Pack sizes4 compare ↓
Also comes in: 113 g 67385-0701-04 170 g 67385-0701-03 907 g 67385-0701-01
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 67385-701-02
Product NDC 67385-701
11-digit billing NDC 67385070102
UNII L7T10EIP3A, J8D9175Q0G
Application # M017
SPL Set ID 2f736307-5cd4-4a76-9044-4aeecba096cc
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-03
Route TOPICAL
Dosage form CREAM
Substance MENTHOL; METHYL SALICYLATE 2-ETHYLBUTYRATE
Why two NDCs? The FDA registers this code as 67385-701-02 — 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 → 67385-0701-02. 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

LabelerGarcoa, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code67385
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio8 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 a topical cream marketed as an over-the-counter pain reliever under FDA's OTC monograph rules. It contains menthol and methyl salicylate, which are commonly used in topical products to create a warming or cooling sensation and are typically applied to the skin for minor aches and muscle discomfort. The product also includes 2-ethylbutyrate, an ingredient often found in analgesic formulations. This is not a prescription medication and does not require individual FDA approval as a new drug application.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 344821WD61
    Emu oil is a natural fat derived from emu birds, used in some medicines as an emollient and penetration enhancer to help active ingredients absorb through the skin and soften the formulation.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • UNII 750W5330FY
    Glucosamine hydrochloride is an amino sugar derived from shellfish or produced synthetically. In medicines, it serves as an active nutritional ingredient rather than a typical inactive excipient, used to support joint and cartilage function.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII H5BJH23Z9A
    A natural polymer extracted from porcine (pig) cartilage tissue. It acts as a binder to hold tablet ingredients together and may improve the product's texture and consistency during manufacturing.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 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.
  • UNII SAS9Z1SVUK
    A natural oil extracted from ginger root that adds flavor and aroma to the medicine. It may also serve as a preservative or help mask unpleasant tastes in the formulation.

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

The official label also statesallantoin, aloe barbadensis leaf juice, benzyl alcohol, carbomer, ceteareth-20, cetearyl alcohol, cetyl alcohol, dimethicone, dimethyl sulfone, emu oil, fragrance, glucosamine HCl, panthenol, phenoxyethanol, polysorbate 20, red 33, sodium chondroitin sulfate, sodium hydroxide, stearic acid, water, zingiber officinale (ginger) root extract.

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.
Try another pack size: 113 g 170 g 907 g
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
Pain Relieving Cream Analgesic 1 mg/100g; 2-ETHYLBUTYRATE 1.5 mg/100gthis 67385-0701-02 Garcoa, 453.6 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
67385-0701-01 907 g in 1 BOTTLE, PUMP (67385-701-01) 2026-08-03 Active
67385-0701-02 You're viewing this 453.6 g in 1 JAR (67385-701-02) 2026-08-03 Active
67385-0701-03 170 g in 1 BOTTLE, DISPENSING (67385-701-03) 2026-08-03 Active
67385-0701-04 113 g in 1 JAR (67385-701-04) 2026-08-03 Active

Pack size FAQ

What quantity is in NDC 67385-0701-02?
NDC 67385-0701-02 contains 453.6 g — 453.6 g in 1 jar.
What is the difference between NDC 67385-0701-02 and NDC 67385-0701-04?
Both are Pain Relieving Cream Analgesic Menthol, Unspecified Form and Methyl Salicylate 1 mg/100g; 2-ETHYLBUTYRATE 1.5 mg/100g Cream — the drug itself is identical. NDC 67385-0701-02 is the 453.6 g package, while NDC 67385-0701-04 is the 113 g package.
What NDC number is used to bill for this package of Pain Relieving Cream Analgesic Menthol, Unspecified Form and Methyl Salicylate 1 mg/100g; 2-ETHYLBUTYRATE 1.5 mg/100g Cream?
Bill NDC 67385-0701-02 — the 11-digit billing format is 67385070102. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 67385-701-02, 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: 67385-0701-02, written without dashes as 67385070102. 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 67385-0701-02, the first segment (67385) is the labeler code FDA assigned to Garcoa, Inc.; the middle segment (0701) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Garcoa, Inc.. 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 3 other package presentations of this same product, including 113 g (67385-0701-04), 170 g (67385-0701-03), 907 g (67385-0701-01). 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?
Garcoa, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Use(s) For the temporary relief of minor aches and pains of muscles and joints; associated with simple backache, arthritis, strains, bruises, and sprains.

⏱️ Dosage and Administration 31 words ▾

Directions Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: consult a doctor.

⚠️ Warnings 146 words ▾

Warnings For external use only For external use only. ALLERGY ALERT If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product •Avoid contact with eyes •Use only as directed •Perform a patch test prior to use.

A transient burning sensation may occur upon application. With regular use, this sensation generally disappears after several days. •Do not apply to wounds or damaged skin •Do not bandage tightly •Do not use with a heating pad. Stop use and ask a doctor if •severe burning persists or blistering occurs •condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Pregnancy/Breastfeeding If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 7 words ▾

Active ingredient(s) Menthol 10% Methyl Salicylate 15%

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients allantoin, aloe barbadensis leaf juice, benzyl alcohol, carbomer, ceteareth-20, cetearyl alcohol, cetyl alcohol, dimethicone, dimethyl sulfone, emu oil, fragrance, glucosamine HCl, panthenol, phenoxyethanol, polysorbate 20, red 33, sodium chondroitin sulfate, sodium hydroxide, stearic acid, water, zingiber officinale (ginger) root extract.

🎯 Purpose 5 words ▾

Purpose Topical analgesic Topical analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67385-0512-01 · Garcoa, 67385-0702-01 · Garcoa, →
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.