Home › NDC Lookup › Ingredients › Menthol Roll On › 76348-0971-03
MG PLUS ROLL ON Menthol 4.2 g/84g Liquid, 84 g — NDC 76348-0971-03 package photo

MG PLUS ROLL ON Menthol 4.2 g/84g Liquid, 84 g

by RENU LABORATORIES, LLC · 84 g in 1 BOTTLE, WITH APPLICATOR (76348-971-03)
NDC 76348-0971-03
🏷️ FDA NDC (as labeled) 76348-971-03 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) 76348-971-03
Product NDC 76348-971
11-digit billing NDC 76348097103
UNII L7T10EIP3A
Application # M017
SPL Set ID 535dc42f-38c7-2afc-e063-6294a90ae23d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-08
Route TOPICAL
Dosage form LIQUID
Substance MENTHOL
Why two NDCs? The FDA registers this code as 76348-971-03 — 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 → 76348-0971-03. 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

LabelerRENU LABORATORIES, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code76348
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio30 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

📗 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.

🧪 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 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 OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 69VJ1LPN1S
    Cannabis sativa seed oil is a plant-based oil derived from hemp seeds. It's used in medicines as a carrier or emollient to help deliver active ingredients and improve product texture and absorption.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII DG4F8T839X
    A plant extract from comfrey leaves used as a natural ingredient in formulations. It may serve as a soothing agent or botanical additive in topical or oral preparations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 273FM27VK1
    A plant-derived cellulose compound used as a binder and thickener in medications. It helps hold tablet ingredients together and can increase the thickness of liquid formulations.
  • 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.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII 12X9JI52BS
    A plant extract from common mallow flowers used as a natural colorant and flavoring agent. It may add color, taste, or soothing properties to the medicine's appearance and flavor.
  • 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 CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.

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

The official label also statesInactive Ingredients: Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil, Deionized Water, Glycerin, Malva Sylvestris (Mallow) Flower Extract, Symphytum Officinale (Comfrey) Leaf Extract, Calendula Officinalis (Marigold) Flower Extract, Chamomilla Recutita (Matricaria) (Chamomile) Flower Extract, Panax Ginseng Root Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Hydroyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.

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 mLPer 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
Mg Plus Roll On 4.2 g/84gthis 76348-0971-03 RENU 84 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
Jun 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
76348-0971-03 You're viewing this 84 g in 1 BOTTLE, WITH APPLICATOR (76348-971-03) 2026-06-08 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 76348-971-03, 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: 76348-0971-03, written without dashes as 76348097103. 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 76348-0971-03, the first segment (76348) is the labeler code FDA assigned to RENU LABORATORIES, LLC; the middle segment (0971) 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 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.

📄 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 📋 Description
🎯 Indications and Usage 30 words ▾

When using this product Do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin do not use with heating pads or other heating devices

⏱️ Dosage and Administration 58 words ▾

Uses for the temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, bruises and arthritis Directions adults and children 12 years of age and older, apply to affected areas no more than 10 times a day as needed for pain children under 12 years of age: do not use, consult a doctor.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active Ingredient: Menthol 5 %

🧪 Inactive Ingredients 67 words ▾

Inactive Ingredients: Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil, Deionized Water, Glycerin, Malva Sylvestris (Mallow) Flower Extract, Symphytum Officinale (Comfrey) Leaf Extract, Calendula Officinalis (Marigold) Flower Extract, Chamomilla Recutita (Matricaria) (Chamomile) Flower Extract, Panax Ginseng Root Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Hydroyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.

🎯 Purpose 3 words ▾

Purpose External analgesic

📋 Description 7 words ▾

Purpose . . . . Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76348-0970-01 · Renu 76348-0980-04 · 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.