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EXTREME EMU Menthol, Methyl Salicylate 11.2 g/112g; 2.24 g/112g Cream, 112 g — NDC 76348-495-04 (Billing 76348-0495-04)

by Renu Laboratories, LLC · 112 g in 1 TUBE

This is a package of 112 g of EXTREME EMU Menthol, Methyl Salicylate 11.2 g/112g; 2.24 g/112g Cream from Renu Laboratories, LLC, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 76348-0495-04
🏷️ FDA NDC (as labeled) 76348-495-04 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 76348-495-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76348 labeler · 495 product · 04 package
Package marketed since
Sep 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7634849504 5
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76348-495-04
Product NDC 76348-495
11-digit billing NDC 76348049504
RxCUI 311503
UNII LAV5U5022Y, L7T10EIP3A
Application # M017
SPL Set ID 4393b57b-1e70-b8dd-e063-6294a90ae748
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-01
Route TOPICAL
Dosage form CREAM
Substance METHYL SALICYLATE; MENTHOL
Quick answers
  • RxCUI (RxNorm): 311503
Why two NDCs? The FDA registers this code as 76348-495-04 — 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 → 76348-0495-04. 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

📗 Our plain-language guide HelloPharmacist
  • It is used on the skin for short-term relief of minor muscle and joint aches. That includes arthritis, backache, strains, sprains and bruises. Some products, like Diclofenac Sodium...
  • Apply it only to clean, intact skin, and follow your product's directions on how often. Wash your hands after using creams or handling patches, and keep it away from your eyes. Don...
  • A short burning feeling, redness or mild irritation where you apply it is the most common. It usually fades in several days. Stop and call your doctor if you get severe burning, bl...
  • Be careful. Methyl salicylate is a salicylate, related to aspirin, and labels say to talk to a doctor first if you are prone to allergic reactions to aspirin or salicylates. Some l...
📖 Read our full Menthol / Methyl Salicylate 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76348-0495-04 You're viewing this Main listing 112 g in 1 TUBE 2024-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mencylate Pain Relieving 100 mg/mL; 20 mg/mL 59088-0215-05 PureTek 59 ml — — FDA listed —
Capasil Pain Relieving 100 mg/mL; 20 mg/mL 59088-0434-05 PureTek 59 ml — — FDA listed —
IceQuake Analgestic White 10 g/100g; 2 g/100g 69822-0310-02 Southern 60 g — — FDA listed —
Tricylate 20 mg/g; 100 mg/g 73352-0575-04 Trifluent 1 tube — — FDA listed —
Arctic Heat 11.2 g/112g; 2.24 g/112g 76348-0414-01 Renu 112 g — — FDA listed —
Extreme Emu 11.2 g/112g; 2.24 g/112gthis 76348-0495-04 Renu 112 g — — FDA listed —
5Kind DMSO 20 mg/mL; 100 mg/mL 85978-0631-00 5KIND 118 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.

🧪 Avoiding an ingredient? See Menthol / Methyl Salicylate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • 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 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • 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 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 5F4963KLHS
    A synthetic polymer created from acrylamide and sodium acryloyldimethyltaurate that thickens and stabilizes liquid or semi-solid formulations. It helps maintain consistent texture and prevents separation of ingredients in creams, gels, and lotions.
  • 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 J1M3NA843L
    A spicy pepper extract used as a flavoring agent in medicines. It adds taste to mask bitter drug flavors and improve palatability, especially in liquid or chewable formulations.
  • 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.

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

The official label also statesAllantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

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

LabelerRenu Laboratories, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code76348
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from Renu Laboratories, LLC labeler code 76348

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

USES Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

⏱️ Dosage and Administration 23 words ▾

Directions Adults and children 12 years of age and older: Apply directly to affected area no more than 3 to 4 times daily.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 7 words ▾

ACTIVE INGREDIENTS Menthol 2% Methyl Salicylate 10%

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredients Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

🎯 Purpose 5 words ▾

PURPOSE Topical Analgesic Topical Analgesic

📄 When Using This Product 40 words ▾

When using this product Do not apply to wounds or damaged skin Do not bandage tightly Do not use in or near eyes; if product gets into eyes rinse thoroughly with water Do not use with an electric heating pad

📄 Stop Use and Ask a Doctor If 30 words ▾

Stop use and ask doctor if Conditions worsen Symptoms last for more than 7 days or clear up and occur again within a few days A rash or irritation develops

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, Ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 9 words ▾

Manufactured by: Renu Labs Inc. Ivyland, PA 18974 www.RenuLabs.com

📄 Package Label / Principal Display Panel 11 words ▾

EXTREME EMU TUBE LABEL ART FOR EXTREME EMU EXTREME EMU LABEL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 — Not published for this NDC No photo available yet for this listing.
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 Renu Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Renu Laboratories, LLC 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.
← 76348-0471-04 · RENU 76348-0510-16 · RENU →
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.