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ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM 3.969 g/113.4g Gel, 1 tube — NDC 58980-0615-40 package photo

ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM 3.969 g/113.4g Gel, 1 tube

by STRATUS PHARMACEUTICALS INC · 1 TUBE in 1 BOX (58980-615-40) / 113.4 g in 1 TUBE
NDC 58980-0615-40
🏷️ FDA NDC (as labeled) 58980-615-40 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) 58980-615-40
Product NDC 58980-615
11-digit billing NDC 58980061540
NCPDP billing unit GM — per gram (weight)
RxCUI 808955
UNII L7T10EIP3A
Application # M017
SPL Set ID d27fbc17-46b7-4d52-ba29-c99b6c63144a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-15
Route TOPICAL
Dosage form GEL
Substance MENTHOL, UNSPECIFIED FORM
GPI-14 90229902104007
GPI class Arctic Relief Pain Relieving
GCN Seq No 045818
GCN 91154
HICL code 002600
Ingredient (HICL) Menthol/Camphor
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name ARCTIC RELIEF 3.5% GEL
FDB brand name Arctic Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 58980-615-40 — 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 → 58980-0615-40. 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

LabelerSTRATUS PHARMACEUTICALS INC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code58980
First marketedSep 2017
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

Label name ARCTIC RELIEF 3.5% GEL Ingredient Menthol/Camphor
📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 Read our full Menthol guide →

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 Green
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 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII 1Q953B4O4F
    Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.

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

The official label also statesCamphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified 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
Elgin Pain Relief 35 mg/g 30056-0004-03 Eco-Logics, 85 g — — FDA listed —
Arctic Relief 3.969 g/113.4gthis 58980-0615-40 STRATUS 1 tube — — FDA listed —
Biofreeze 35 mg/mL 59316-0101-10 Reckitt 5 ml — — FDA listed —
PERFORM COOL and SOOTHING PAIN RELIEVING 35 mg/mL 59316-0111-10 Reckitt 3 ml — — Discontinued —
Perform Cool And Soothing Pain Relieving Roll-On 35 mg/mL 59316-0112-10 Reckitt 1 bottle — — FDA listed —
Muscle 3.5 g/100mL 59898-0805-05 WATER-JEL 96 packets — — FDA listed —
Fast Freeze 35 mg/g 66902-0016-01 Natural 1 g — — FDA listed —
Icy Freeze 35 mg/mL 66902-0165-03 NATURAL 1 bottle — — FDA listed —
FREEZE IT Menthol 3.5 g/100g 71726-0004-02 LiquidCapsule 113.4 g — — FDA listed —
FREEZE IT Menthol Roll On 3.5 g/100mL 71726-0005-01 LiquidCapsule 89 ml — — FDA listed —
ORTHOGEL Menthol 3.5% 3.5 g/100g 71726-0007-02 LiquidCapsule 113.4 g — — FDA listed —
ORTHOGEL Menthol 3.5% Roll On 3.5 g/100mL 71726-0008-01 LiquidCapsule 89 ml — — 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

🏛️
2017
On the market since
Sep 2017
📍
2026
Currently FDA-listed
9 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
58980-0615-40 You're viewing this 1 TUBE in 1 BOX (58980-615-40) / 113.4 g in 1 TUBE 2017-09-15 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 58980-615-40, 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: 58980-0615-40, written without dashes as 58980061540. 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 58980-0615-40, the first segment (58980) is the labeler code FDA assigned to STRATUS PHARMACEUTICALS INC; the middle segment (0615) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 STRATUS PHARMACEUTICALS INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
STRATUS PHARMACEUTICALS 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 19 words ▾

Uses Temporary relief from minor aches and pains of sore muscles & joints associated with arthritis backache strains sprains.

⏱️ Dosage and Administration 34 words ▾

Directions Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary. Children under 2 years of age: Consult physician

⚠️ Warnings 137 words ▾

Warnings FOR EXTERNAL USE ONLY . Flammable: Keep away from excessive heat or open flame. Ask a doctor before use if you have sensitive skin.

When Using This Product Avoid contact with the eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with a heating pad or device. Stop Use And Ask A Doctor If Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur. If pregnant or breast-feeding Ask a health professional before use.

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

📦 Storage and Handling 12 words ▾

Other Information Store in a cool dry place with cap closed tightly

🧪 Active Ingredient 6 words ▾

Active Ingredient Natural Menthol USP 3.5%

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients Camphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified water.

🎯 Purpose 4 words ▾

Purpose Cooling Pain Reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58980-0522-40 · Stratus 58980-0818-10 · Stratus →
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.