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PAINGEL UNGUENTO Camphor, Menthol 11 g/100g; 16 g/100g Ointment, 113 g

by NACOR BUSINESS GROUP LLC · 113 g in 1 JAR (85110-116-04)
NDC 85110-0116-04
🏷️ FDA NDC (as labeled) 85110-116-04 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) 85110-116-04
Product NDC 85110-116
11-digit billing NDC 85110011604
RxCUI 1802734
UNII 5TJD82A1ET, L7T10EIP3A
UPC 0755439009741
Application # M017
SPL Set ID 42fab525-b0a5-97fb-e063-6394a90aec6c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-28
Route TOPICAL
Dosage form OINTMENT
Substance CAMPHOR (SYNTHETIC); MENTHOL
Why two NDCs? The FDA registers this code as 85110-116-04 — 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 → 85110-0116-04. 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.

🏭 Manufacturer & labeler

LabelerNACOR BUSINESS GROUP LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85110
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio4 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

🧪 What is this product?

Paingel Unguento is a topical ointment containing camphor and menthol. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for products in its category. Camphor and menthol are counterirritants commonly used in topical products to produce a warming or cooling sensation on the skin, and are typically included in ointments intended for temporary relief of minor discomfort.

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 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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 3T8H1794QW
    Eugenol is a natural oil extracted from clove and other plants. It's used in medicines as a flavoring agent and to provide a mild anesthetic effect in topical products, particularly in dental formulations.
  • 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 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • 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 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesPetrolatum, Cera Alba, Mentha Piperita (Peppermint) Oil, Tapioca Starch, Eugenia Caryophyllus Bud Oil, Curcuma Longa (Turmeric) Root Extract, Glycerin, Water (Aqua), Eugenol.

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
MYCO Clinic Pain Relief 11 g/100g; 16 g/100g 24909-0012-50 Aidance 50 g — — FDA listed —
MYCO Clinic Pain Relief 11 g/100g; 16 g/100g 24909-0013-17 Aidance 10 packets — — FDA listed —
terrasil Bruise and Pain Relief Maximum Strength 16 g/100g; 11 g/100g 24909-0042-50 Aidance 50 g — — FDA listed —
Active Recovery Pain Relief 16 g/100g; 11 g/100g 79845-0768-44 Charlotte's 44 g — — FDA listed —
Paingel Unguento 11 g/100g; 16 g/100gthis 85110-0116-04 NACOR 113 g — — FDA listed —
Icy Hot Pro No-Mess 11 g/100g; 16 g/100g 41167-0079-06 Chattem, 85 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

🏛️
2025
On the market since
Nov 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.

🔬 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 PAINGEL UNGUENTO (this brand).

Top reported reactions

Peripheral Motor Neuropathy2
Agitation1
Drug Abuse1
Dry Mouth1
Dyspnoea1
International Normalised Ratio Increased1
Multiple Organ Dysfunction Syndrome1

Age at onset

Adult1

Reporter sex

8 reports
Male · 63%
Female · 38%

Serious outcomes

Hospitalization4
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85110-0116-04 You're viewing this 113 g in 1 JAR (85110-116-04) 2025-11-28 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 — 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 FDA registers it as 85110-116-04, 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: 85110-0116-04, written without dashes as 85110011604. 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 85110-0116-04, the first segment (85110) is the labeler code FDA assigned to NACOR BUSINESS GROUP LLC; the middle segment (0116) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 NACOR BUSINESS GROUP LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NACOR BUSINESS GROUP 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 20 words ▾

Use for temporary local relief of minor pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

⏱️ Dosage and Administration 52 words ▾

Directions Adults and Children over 12 years of age: Apply a small amount on the affected area. Massage in a circular motion, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age; do not use, consult a doctor.

⚠️ Warnings 17 words ▾

Warnings For external use only. Ask a doctor before use if you have redness over affected area.

🧪 Active Ingredient 6 words ▾

Active ingredients Camphor 11% Menthol 16%

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients Petrolatum, Cera Alba, Mentha Piperita (Peppermint) Oil, Tapioca Starch, Eugenia Caryophyllus Bud Oil, Curcuma Longa (Turmeric) Root Extract, Glycerin, Water (Aqua), Eugenol.

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85110-0003-03 · NACOR 85110-0207-04 · NACOR →
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.