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SANO TI AMO RELIEF AND REPAIR PAIN RELIEF MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) 3 mg/mL; 13.4 mg/mL Cream, 60 mL — NDC 80216-0111-02 package photo

SANO TI AMO RELIEF AND REPAIR PAIN RELIEF MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) 3 mg/mL; 13.4 mg/mL Cream, 60 mL

by Sano Ti Amo, LLC · 60 mL in 1 CONTAINER (80216-111-02)
NDC 80216-0111-02
🏷️ FDA NDC (as labeled) 80216-111-02 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 80216-111-02
Product NDC 80216-111
11-digit billing NDC 80216011102
UNII L7T10EIP3A, 5TJD82A1ET
Application # M017
SPL Set ID 205a89c4-2ae4-4072-af5c-a9ce6154a3f9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2019-10-08
Route TOPICAL
Dosage form CREAM
Substance MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC)
Why two NDCs? The FDA registers this code as 80216-111-02 — 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 → 80216-0111-02. 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

LabelerSano Ti Amo, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code80216
First marketedOct 2019
Product typeHuman Otc Drug
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 containing menthol and synthetic camphor, marketed as an over-the-counter monograph product for pain relief. Menthol and camphor are both counterirritants that are typically used to produce a cooling or warming sensation on the skin, which is thought to distract from or temporarily ease minor muscle and joint discomfort. The product is applied directly to the affected area of skin.

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 2ACZ6IPC6I
    A naturally occurring compound in the body that acts as a neurotransmitter. In medicines, it may serve as a buffer or pH regulator to help stabilize the formulation and maintain proper acidity levels.
  • UNII O80TY208ZW
    Arnica montana is a plant extract used in some formulations as a flavoring agent or traditional botanical ingredient. It may contribute mild taste or aroma to the product.
  • UNII 922OP8YUPF
    A plant-derived substance from astragalus root, used in traditional herbal formulations. It may serve as a natural filler or thickening agent in the finished product.
  • UNII DUB5K84ELI
    Bacopa monnieri is a plant extract traditionally used in herbal preparations. In medicines, it typically serves as an active botanical ingredient or flavoring agent, though it may also function as a natural binder or filler in tablet or capsule formulations.
  • UNII 5K1UO2888Y
    Baptisia tinctoria is a plant extract derived from wild indigo. It may be used in formulations for its potential properties as a natural ingredient or botanical agent, though its specific technical role as an excipient varies by product formulation.
  • 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 B5ONF538PB
    A plant material derived from the cannabis sativa plant. It may serve as an active botanical ingredient or carrier in formulations, though its specific functional role depends on the product's intended use and regulatory status.
  • 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 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 D982V7VT3P
    A plant extract from the narrow-leafed coneflower root, used as a natural flavor, color, or botanical ingredient in some formulations to add taste and appearance to the medicine.
  • UNII 2EMS3QFX65
    A plant extract from the purple coneflower used as a natural flavoring or coloring agent in some medicines. It may also serve as a botanical additive to support the product's overall composition.
  • UNII OS64WTR4KU
    Echinacea purpurea root is a plant extract used in supplements and some medicines. It typically serves as an active botanical ingredient rather than a traditional inactive filler or binder.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • 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 00C2W8NVII
    A synthetic oily liquid made from petroleum-derived materials. It acts as an emulsifier and solubilizer, helping mix water and oil-based ingredients together and keeping them blended throughout the product's shelf life.
  • UNII KV2JZ1BI6Z
    Pyridoxine is a form of vitamin B6, a water-soluble vitamin. It's added to medicines as a nutritional supplement to help maintain adequate B6 levels in the body.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 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.

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

The official label also statesWater, Isopropyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Stearyl Alcohol, Glycerine, Hetoxol C, Cetyl Alcohol, Gamma-aminobutyric Acid, Dimethyl Sulfone (MSM), Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Echinacea, Astragalus Propinquus Root, Phenoxyethanol, Ethylhexylglycerin, Mentha Piperita (Peppermint) Oil, Bacopa Monnieri Extract, Baptisia Tinctoria, Butyrospermum Parkii (Shea Butter), Hemp Seed Oil, Vitamin B6, Hemp Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

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
Sano Ti Amo Relief And Repair Pain Relief 3 mg/mL; 13.4 mg/mLthis 80216-0111-02 Sano 60 ml — — Discontinued —
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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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
80216-0111-02 You're viewing this 60 mL in 1 CONTAINER (80216-111-02) 2019-10-08 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 80216-111-02, 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: 80216-0111-02, written without dashes as 80216011102. 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 80216-0111-02, the first segment (80216) is the labeler code FDA assigned to Sano Ti Amo, LLC; the middle segment (0111) 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.
Who lists this product with the FDA?
Sano Ti Amo, 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
🎯 Indications and Usage 21 words ▾

USE for the temporary relief of aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

⏱️ Dosage and Administration 31 words ▾

DIRECTIONS Adults – 18 and over Apply and gently massage into painful joints and or muscles. Repeat as needed, no more than 4 times per day. Wash hands after each use.

⚠️ Warnings 84 words ▾

WARNINGS: External Use Only Avoid contact with eyes, open cuts, damaged or irritated skin or sensitive areas. Do not use if allergic to any of the ingredients. Those taking Coumadin (blood thinner or warfarin type medications) or have kidney issues/failure should consult their physician before using.

Do not use with other topical products. Do not use if pregnant or nursing. Do not bandage.

Do not apply heat. Keep out of reach of children. If swallowed get medical help or contact Poison Control Center immediately.

🧪 Active Ingredient 7 words ▾

Active Ingredients Camphor .3 % Menthol 1.25%

🧪 Inactive Ingredients 62 words ▾

INACTIVE INGREDIENTS Water, Isopropyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Stearyl Alcohol, Glycerine, Hetoxol C, Cetyl Alcohol, Gamma-aminobutyric Acid, Dimethyl Sulfone (MSM), Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Echinacea, Astragalus Propinquus Root, Phenoxyethanol, Ethylhexylglycerin, Mentha Piperita (Peppermint) Oil, Bacopa Monnieri Extract, Baptisia Tinctoria, Butyrospermum Parkii (Shea Butter), Hemp Seed Oil, Vitamin B6, Hemp Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

🎯 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 ↗
← 80151-0002-02 · FLEMING 80228-0349-00 · Universal →
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.