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Hempe HOT Muscle and Joint Gel 2.5 mg/100mL Gel, 50 mL — NDC 87916-0002-50 package photo

Hempe HOT Muscle and Joint Gel 2.5 mg/100mL Gel, 50 mL

by Healthcare International Research Limited · 50 mL in 1 BOTTLE, DISPENSING (87916-002-50)
NDC 87916-0002-50
🏷️ FDA NDC (as labeled) 87916-002-50 billing pads the product segment with a zero
This package
Contains50 mL Pack sizes2 compare ↓
Also comes in: 150 ml 87916-0002-15
OTC On market Non-controlled
🗂️ Data synced Aug 13, 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) 87916-002-50
Product NDC 87916-002
11-digit billing NDC 87916000250
UNII L7T10EIP3A
Application # M017
SPL Set ID 5854a80e-c92b-3ff5-e063-6294a90a2d05
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 87916-002-50 — 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 → 87916-0002-50. 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

LabelerHealthcare International Research Limited
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code87916
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio2 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?

Hempe HOT Muscle and Joint Gel is a topical gel product containing menthol that is marketed as an over-the-counter monograph drug. Menthol is commonly used in topical muscle and joint products for its cooling and warming sensations, which may help provide temporary relief of minor aches and discomfort when applied to the skin. This product is intended for external use only.

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.

💊 What it looks like

Color pink
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 DW4WDF59AP
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, it dissolves active ingredients, helps preserve the formula, and improves how the body absorbs certain drugs.
  • 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 19GBJ60SN5
    A naturally derived compound from cannabis plants used as an active pharmaceutical ingredient in certain FDA-approved medications. It is included to deliver the therapeutic substance rather than serve a traditional formulation role like binding or flavoring.
  • UNII N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • UNII Z525CBK9PG
    Acid Red 18 is a synthetic red dye used as a colorant in medicines. It gives tablets, capsules, and liquids their red or pink color so products are visually identifiable.
  • UNII 057N7SS26Y
    A clear, oily liquid derived from succinic acid and alcohol chains. It functions as a plasticizer and solvent in formulations, helping soften coatings and improve flexibility of film-coated tablets.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII VCA5491KVF
    A fragrant oil extracted from clove leaves, used as a flavoring and aromatic agent to mask unpleasant tastes or add pleasant scent to medicines.
  • UNII V9OSB376X8
    A chemical compound made from eugenol, a natural oil from clove plants. Used in medicines as a flavoring agent and for its mild aromatic properties in formulations.
  • UNII L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • 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 TD1MUT01Q7
    Hemp is a plant-derived ingredient used as a binder or filler in solid dosage forms like tablets and capsules. It helps hold other ingredients together and adds bulk to the medicine.
  • UNII 4YI0729529
    A synthetic oil made from plant-derived hydrocarbons that has been chemically saturated. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and improve tablet handling.
  • UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII 6D4M1DAL6O
    Polyoxyl 35 castor oil is a synthetic compound made by chemically treating castor oil. It works as a solubilizer and emulsifier to help dissolve and evenly mix oily and water-based ingredients in medicines.
  • UNII GIA7T764OD
    A silicone-based ingredient combined with polyethylene glycol. It acts as an emulsifier and surfactant to help blend oils and water-based ingredients, and reduces foaming in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • UNII S2ULN37C9R
    A synthetic chemical compound derived from vanillin that acts as a flavoring agent and fragrance enhancer in medicines. It provides vanilla-like taste and aroma to improve the palatability of oral medications.

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

The official label also stateslnactive lngredients • Aqua, Alcohol Denat., Glycerin, PEG-35 Castor Oil, Sodium Polyacrylate, Eugenia Caryophyllus leaf Oil (Clove leaf), Hydrogenated Polydecene, Eugenol (Clove Oil), Hemp Seed Oil, PEG-8 Dimethicone, Tocopherol (Vitamin E), Vanillyl Butyl Ether, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Trideceth-6, Cannabidiol (CBD), Eucalyptus Globulus leaf Oil (Eucalyptus), limonene, Geraniol, Sodium Chloride, Sodium Sulfate, CI 16255.

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.
Try another pack size: 150 ml
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
Hempe HOT Muscle and Joint Gel 2.5 mg/100mLthis 87916-0002-50 Healthcare 50 ml — — 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
Aug 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
87916-0002-15 150 mL in 1 BOTTLE, DISPENSING (87916-002-15) 2026-08-01 Active
87916-0002-50 You're viewing this 50 mL in 1 BOTTLE, DISPENSING (87916-002-50) 2026-08-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 87916-0002-50?
NDC 87916-0002-50 contains 50 mL — 50 ml in 1 bottle, dispensing.
What is the difference between NDC 87916-0002-50 and NDC 87916-0002-15?
Both are Hempe HOT Muscle and Joint Gel 2.5 mg/100mL Gel — the drug itself is identical. NDC 87916-0002-50 is the 50 mL package, while NDC 87916-0002-15 is the 150 ml package.
What NDC number is used to bill for this package of Hempe HOT Muscle and Joint Gel 2.5 mg/100mL Gel?
Bill NDC 87916-0002-50 — the 11-digit billing format is 87916000250. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 87916-002-50, 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: 87916-0002-50, written without dashes as 87916000250. 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 87916-0002-50, the first segment (87916) is the labeler code FDA assigned to Healthcare International Research Limited; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Healthcare International Research Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 150 ml (87916-0002-15). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Healthcare International Research Limited 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 18 words ▾

Temporary relief of minor aches and pains of muscles, joints, associated with simple backache, arthritis, strains, bruises, sprains

⏱️ Dosage and Administration 40 words ▾

Directions • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor. Massage until absorbed by skin.

⚠️ Warnings 38 words ▾

Warnings • For external use only • Test on small area of skin before full application • Protect from sunlight • Store in a cool dry place • Wash hands after use • If pregnant consult your doctor

🧪 Active Ingredient 2 words ▾

Menthol 2.5%

🧪 Inactive Ingredients 56 words ▾

lnactive lngredients • Aqua, Alcohol Denat., Glycerin, PEG-35 Castor Oil, Sodium Polyacrylate, Eugenia Caryophyllus leaf Oil (Clove leaf), Hydrogenated Polydecene, Eugenol (Clove Oil), Hemp Seed Oil, PEG-8 Dimethicone, Tocopherol (Vitamin E), Vanillyl Butyl Ether, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Trideceth-6, Cannabidiol (CBD), Eucalyptus Globulus leaf Oil (Eucalyptus), limonene, Geraniol, Sodium Chloride, Sodium Sulfate, CI 16255.

🎯 Purpose 2 words ▾

Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87916-0001-15 · Healthcare 87917-0001-02 · Kalahari →
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.