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GuruNanda Oral Pain Relief Menthol 15 mg/mL Rinse — NDC 70708-0011-08 package photo

GuruNanda Oral Pain Relief Menthol 15 mg/mL Rinse

by GURUNANDA, LLC · 1 BOTTLE in 1 CARTON (70708-011-08) / 237 mL in 1 BOTTLE
NDC 70708-0011-08
🏷️ FDA NDC (as labeled) 70708-011-08 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 →
⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70708-011-08
Product NDC 70708-011
11-digit billing NDC 70708001108
RxCUI 2720404
UNII BZ1R15MTK7
Application # M022
SPL Set ID 3b8f3562-0e46-bea4-e063-6294a90adb71
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-04
Route ORAL
Dosage form RINSE
Substance LEVOMENTHOL
Why two NDCs? The FDA registers this code as 70708-011-08 — 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 → 70708-0011-08. 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

LabelerGURUNANDA, LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code70708
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio9 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 →
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 N9PR3490H9
    A naturally derived form of vitamin E that acts as an antioxidant in medicines. It prevents oils and fats in the product from breaking down or becoming rancid during storage.
  • UNII FJ1H6M2JG9
    A blend of plant-derived fatty acids that helps dissolve and deliver active ingredients. It acts as a solvent and absorption enhancer in soft gelatin capsules and liquid formulations.
  • UNII 1C6V77QF41
    Cholecalciferol is vitamin D3, a fat-soluble vitamin added to medicines as a nutritional supplement or active ingredient fortification. It helps the body absorb calcium and support bone health.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 1VH544O5AT
    A natural resin derived from the copaiba tree, used as a binder and film-former in medications. It helps hold tablet ingredients together and can create protective coatings on solid dosage forms.
  • UNII QPP5U30FSD
    A natural oil extracted from zedoary, a plant related to turmeric. It serves as a flavoring agent and may help mask bitter tastes in medicines.
  • UNII 8427BML8NY
    Menaquinone-7 is a form of vitamin K2, a fat-soluble compound. It's added to some medications and supplements as a nutritional ingredient to support the product's intended vitamin content.
  • 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 H74221J5J4
    Myrrh oil is a fragrant resin extracted from myrrh tree bark. It is used in medicines as a flavoring agent and to add aroma or taste to the product.
  • UNII QY11DDA752
    A plant extract from the salvadora persica tree, traditionally used in oral care products. In medicines, it may serve as a natural flavoring agent, antimicrobial component, or texture modifier.
  • UNII C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical 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 ER3FV125H7
    A plant extract from the Zanthoxylum armatum fruit, commonly known as Sichuan pepper or Nepal pepper. It may function as a flavoring agent, preservative, or aromatic component in the formulation.

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

The official label also statesCaprylic/Capric/Lauric Triglyceride, Clove (Eugenia caryophyllus) Oil, Peppermint (Mentha piperita) Oil, Spearmint (Mentha spicata) Oil, Winged Prickly Ash (Zanthoxylum alatum) Oil, Copaiba Balsam (Copaifera officinalis) Oil, Myrrh (Commiphora myrrha) Oil, Tea Tree (Melaleuca alternifolia) Oil, Thyme (Thymus zygis) Oil, White Tumeric (Curcuma zedoaria) Oil, D-Alpha-Tocopherol (Vitamin E), Miswak (Salvadora persica) Extract, Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7)

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 eachPer 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
GuruNanda Oral Pain Relief 15 mg/mLthis 70708-0011-08 GURUNANDA, 1 bottle — — 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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
70708-0011-08 You're viewing this 1 BOTTLE in 1 CARTON (70708-011-08) / 237 mL in 1 BOTTLE 2025-07-04 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 70708-011-08, 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: 70708-0011-08, written without dashes as 70708001108. 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 70708-0011-08, the first segment (70708) is the labeler code FDA assigned to GURUNANDA, LLC; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 GURUNANDA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GURUNANDA, 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 33 words ▾

Uses For temporary pain relief due to minor irritation or injury of the mouth and gums resulting from: Dental procedures Orthodontic appliances Dentures Canker Sores Other minor irritations of the mouth and gums

⏱️ Dosage and Administration 86 words ▾

Directions Adults and children 6 years of age and older: Pour 10 mL into the measuring cup. Swish, gargle, push between teeth, or allow to remain in place for at least 2 minutes. Do not swallow. Spit out into a trash can. Use up to twice daily, or as directed by a dentist or doctor. Brush your teeth after use. Children under 12 years of age: Should be supervised in the use of this product. Children under 6 years of age: Consult a dentist or doctor

⚠️ Warnings 98 words ▾

Warnings Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor. When using this product use only as directed. Read and follow all directions and warnings on this label. Do not swallow Do not exceed recommended dosage. Stop use and ask doctor if irritation, pain or redness persists or worsens swelling, rash or fever devleops sore mouth symptoms do not improve in 7 days

When using this product use only as directed. Read and follow all directions and warnings on this label. Do not swallow Do not exceed recommended dosage.

🧪 Active Ingredient 2 words ▾

Menthol 1.5%

🧪 Inactive Ingredients 59 words ▾

Inactive ingredients Caprylic/Capric/Lauric Triglyceride, Clove (Eugenia caryophyllus) Oil, Peppermint (Mentha piperita) Oil, Spearmint (Mentha spicata) Oil, Winged Prickly Ash (Zanthoxylum alatum) Oil, Copaiba Balsam (Copaifera officinalis) Oil, Myrrh (Commiphora myrrha) Oil, Tea Tree (Melaleuca alternifolia) Oil, Thyme (Thymus zygis) Oil, White Tumeric (Curcuma zedoaria) Oil, D-Alpha-Tocopherol (Vitamin E), Miswak (Salvadora persica) Extract, Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7)

🎯 Purpose 2 words ▾

Oral Analgesic

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