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Salicor triethanolamine salicylate 40.2 mg Patch, 15 patches — NDC 83881-0501-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Salicor triethanolamine salicylate 40.2 mg Patch, 15 patches — NDC 83881-501-15 (Billing 83881-0501-15)

by Clinic Pharma · 15 PATCH in 1 PACKAGE

This is a package of 15 patches of Salicor triethanolamine salicylate 40.2 mg Patch from Clinic Pharma, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 83881-0501-15
🏷️ FDA NDC (as labeled) 83881-501-15 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 83881-501-15 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83881 labeler · 501 product · 15 package
Package marketed since
May 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8388150115 7
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83881-501-15
Product NDC 83881-501
11-digit billing NDC 83881050115
SPL Set ID 78b5235b-ed77-49ae-960b-e1c0145237db
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-22
Route TRANSDERMAL
Dosage form PATCH
Substance TEA-SALICYLATE
Why two NDCs? The FDA registers this code as 83881-501-15 — 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 → 83881-0501-15. 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

🧪 What is this product?

This is a transdermal patch containing triethanolamine salicylate, a salt form of salicylate. Salicylates are typically used in topical products for their anti-inflammatory and keratolytic (skin-softening) properties, commonly appearing in over-the-counter preparations intended for localized pain relief and skin conditions. This product is marketed without an approved FDA application.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83881-0501-15 You're viewing this Main listing 15 PATCH in 1 PACKAGE 2026-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Salicor 40.2 mgthis 83881-0501-15 Clinic 15 patches — — FDA listed —
Salicor 40.2 mg 80425-0592-01 Advanced 15 patches — — 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
Oct 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.

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 737PT7E2CY
    A synthetic polymer (plastic-like material) made by combining multiple acrylate compounds. It serves as an adhesive and film-former in transdermal patches, helping the medication stick to skin while controlling how the drug releases over time.
  • UNII 456148SDMJ
    Heptane is a clear liquid hydrocarbon solvent derived from petroleum. In medicines, it's used as a solvent or extraction agent during manufacturing to help dissolve and process active ingredients.
  • 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 S34RY76LK6
    Kollidon SR is a synthetic polymer used as a binder and film-former in tablets and capsules. It helps hold ingredients together and can control how quickly the medicine dissolves in your stomach.

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

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

LabelerClinic Pharma
Labeler code83881
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Clinic Pharma labeler code 83881

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings and Cautions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 53 words ▾

INDICATION AND USAGE Salicor™ is indicated for the temporary relief of minor aches and pains of muscles and joints associated with: arthritis, simple backache, muscle strains and sprains, bruises, bursitis, and dysmenorrhea. Salicor™ provides a localized analgesic effect directly at the site of pain, offering convenience and sustained relief compared to cream formulations.

⏱️ Dosage and Administration 196 words ▾

DOSAGE AND ADMINISTRATION For adults 18 years and older: • Clean and dry the affected area • Locate the tear notch on the edge of the pouch. Tear open at the notch or carefully cut open the pouch with scissors, taking care not to cut the system inside • Remove the transparent release liner before applying Salicor™ to the skin • Apply one Salicor™ to the affected area of pain and leave it in place for 8 to 12 hours • Apply only one Salicor™ at a time • If pain persists, the used Salicor™ may be replaced with a new one for up to 8 to 12 more hours • Always remove and properly dispose of the used Salicor™ before applying a new one • Salicor™ may be cut into smaller sizes with scissors prior to removing the release liner • Safely discard the used Salicor™ (whole or cut pieces) where children and pets cannot access it • Wash hands with soap and water after applying or removing Salicor™ Visual Guide provided below: These highlights do not include all the information needed to use Salicor™ safely and effectively.

See full prescribing information for Salicor™ dosing

⚠️ Warnings and Cautions ~1 min read ▾

PRECAUTIONS General If irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides. When Salicor™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Stop use and ask a doctor if • Condition worsens • Symptoms persist for more than 7 days, or symptoms return within a few days after discontinuing use • Redness is present • Irritation develops Hepatic Disease Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of triethanolamine salicylate because of their inability to metabolize triethanolamine salicylate normally.

Allergic Reactions Although rare, allergic reactions to oral or external triethanolamine salicylate may occur. Seek emergency medical help if you experience hives, difficulty breathing, or swelling of the face, lips, tongue, or throat, as these may indicate a serious allergic reaction. Non-intact Skin Although not tested, application to broken or inflamed skin may result in higher blood concentrations of triethanolamine salicylate from increased absorption.

Salicor™ is only recommended for use on intact skin. External Heat Sources Placement of external heat sources, such as heating pads or electric blankets, over Salicor™ is not recommended, as this has not been evaluated and may increase plasma triethanolamine salicylate levels. Eye Exposure Although not studied, contact of Salicor™ with the eyes should be avoided based on the findings of severe eye irritation with the use of similar animal products.

If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. Information for Patients Methemoglobinemia Inform patients that the use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experiences the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

🔄 Drug Interactions 90 words ▾

Drugs That May Cause Methemoglobinemia When Used with Salicor™ Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia Class: Nitrates/Nitrites: Local anesthetics: Antineoplastic agents: Antibiotics: Antimalarials: Anticonvulsants: Other drugs: Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides chloroquine, primaquine phenobarbital, phenytoin, sodium valproate acetaminophen, metoclopramide, quinine, sulfasalazine carcinogenesis, mutagenesis

🤰 Pregnancy 98 words ▾

Pregnancy Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby.

You should not take NSAIDs after about 30 weeks of pregnancy. Pregnancy Category B. Salicor™ has not been studied in pregnancy.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 103 words ▾

OVERDOSAGE Salicor™ is intended for external use only. While systemic toxicity is unlikely with proper use, accidental ingestion or excessive application may lead to salicylate toxicity. Symptoms of overdose may include: nausea and vomiting, tinnitus (ringing in the ears), dizziness and confusion, rapid breathing (hyperventilation), sweating, headache, and fever.

In severe cases, overdose may lead to more serious symptoms such as: seizures, hallucinations, respiratory distress, kidney failure, and metabolic acidosis. If overdose is suspected, discontinue use immediately and seek medical attention. Treatment is supportive and symptomatic.

Healthcare professionals may need to monitor fluid and electrolyte balance, correct acid-base disturbances, and manage any complications.

📦 How Supplied / Storage and Handling 14 words ▾

HOW SUPPLIED Salicor™ is available as the following: 1 carton, 15 systems NDC 83881-501-15

📦 Storage and Handling 38 words ▾

STORAGE AND HANDLING Avoid contact with the eyes. Keep away from excessive heat and direct sunlight. Salicor™ should be kept out of reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

📋 Description 70 words ▾

DESCRIPTION Salicor™ is an external analgesic product containing 10% triethanolamine salicylate as the active ingredient. Triethanolamine salicylate is an organic compound formed between triethanolamine and salicylic acid, where triethanolamine neutralizes the acidity of salicylic acid. This external analgesic is designed for temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

Unlike other external analgesics, triethanolamine salicylate has no distinct odor, which improves patient acceptability.

🧬 Pharmacokinetics ~1 min read ▾

Pharmacokinetics Absorption Following external administration of Salicor™ to healthy volunteers, no detectable levels of salicylic acid were found in the serum, indicating low systemic absorption. This minimal absorption is advantageous as it reduces the risk of systemic side effects commonly associated with oral salicylates. Studies have shown that urinary recovery of total salicylate during the first 24 hours after external application was only 6.9 mg, which represents approximately 1.4% of the total dose applied.

Distribution Triethanolamine salicylate is transported and distributed within cells and tissues through various mechanisms. Studies in canines and humans have shown that transdermal absorption of salicylate from triethanolamine salicylate preparations applied to skin is consistent and reproducible, with measurable tissue salicylate levels at the application site. The distribution appears to be concentration-dependent, with tissue salicylate levels directly proportional to the concentrations of the active ingredient in the formulation up to the 10% preparation.

Metabolism While specific metabolism data for externally applied Salicor™ is limited due to its low systemic absorption, the small amount that does enter the systemic circulation is likely metabolized similarly to other salicylates. The primary metabolic pathways include: 1. Conjugation with glycine to form salicyluric acid (approximately 75%).

2. Conjugation with glucuronic acid to produce salicyl acyl and phenolic glucuronides (about 15%). 3.

Oxidation to gentisic acid and other hydroxylated derivatives (minor pathway). Free, unmodified salicylate accounts for 10–30% of excreted metabolites, depending on dosage and individual factors like urinary pH. Metabolism primarily occurs in the liver, with some possible local metabolism in skin tissues.

Excretion Triethanolamine salicylate is primarily excreted through the urine after metabolism. Following external application of a 10% formulation, approximately 1.4% of the total dose is recovered in the urine as salicylate within the first 24 hours, indicating low systemic absorption.

🧬 Pharmacodynamics 97 words ▾

Pharmacodynamics Triethanolamine salicylate is an external analgesic that functions by inhibiting cyclooxygenase (COX) enzymes, which are involved in the production of pro-inflammatory factors such as prostaglandins and thromboxanes. These enzymes play a crucial role in generating pain and inflammation in conditions like arthritis, muscle strains, and sprains. While salicylates, such as aspirin, are known to inhibit COX enzymes, the specific mechanism of triethanolamine salicylate in topical applications may differ slightly.

It is generally believed to act similarly to topical NSAIDs, reducing inflammation and pain locally. However, the evidence regarding its selectivity towards COX-2 enzymes is less clear.

📄 Patient Package Insert 7 words ▾

Patient Package Insert ppi front ppi back

📄 Package Label / Principal Display Panel 4 words ▾

carton front carton back

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Salicor (this brand).

Top reported reactions

Agitation1
Asthenia1
Choking Sensation1
Cognitive Disorder1
Delusion1
Depressed Mood1
Dysuria1

Age at onset

Elderly2

Reporter sex

2 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization2
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 Clinic Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Clinic Pharma 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 83881-0455-35 · Clinic 83883-0001-00 · CVL →
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.