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Rael PAIN RELIEF ROLL-ON Analgesic CAMPHOR (SYNTHETIC) and MENTHOL, UNSPECIFIED FORM 40 mg/mL; 40 mg/mL Liquid — NDC 72863-076-01 (Billing 72863-0076-01)

by Rael, Inc. · 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 50 mL in 1 BOTTLE, WITH APPLICATOR

This is a package of Rael PAIN RELIEF ROLL-ON Analgesic CAMPHOR (SYNTHETIC) and MENTHOL, UNSPECIFIED FORM 40 mg/mL; 40 mg/mL Liquid from Rael, Inc., marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.

NDC 72863-0076-01
🏷️ FDA NDC (as labeled) 72863-076-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 72863-076-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
72863 labeler · 076 product · 01 package
Package marketed since
Oct 9, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7286307601 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72863-076-01
Product NDC 72863-076
11-digit billing NDC 72863007601
RxCUI 2696072
UNII 5TJD82A1ET, L7T10EIP3A
Application # M017
SPL Set ID e6c49606-7c13-4dc6-a22d-ba54173ba788
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-09
Route TOPICAL
Dosage form LIQUID
Substance CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 2696072
Why two NDCs? The FDA registers this code as 72863-076-01 — 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 → 72863-0076-01. 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 topical roll-on liquid pain relief product containing camphor and menthol as its active ingredients. Both substances are commonly used in over-the-counter topical pain relievers, where they are applied directly to the skin. Camphor and menthol typically produce a warming or cooling sensation and are used to temporarily soothe minor muscle and joint discomfort. This product is marketed as an OTC monograph drug, meaning it follows established FDA rules for this category of analgesic.

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 mLPer 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
72863-0076-01 You're viewing this Main listing 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 50 mL in 1 BOTTLE, WITH APPLICATOR 2024-10-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rael PAIN RELIEF ROLL-ON Analgesic 40 mg/mL; 40 mg/mLthis 72863-0076-01 Rael, 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • 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 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII UP0M8M3VZW
    A fragrant essential oil extracted from lemongrass plants, used primarily as a flavoring and fragrance agent to improve taste and aroma in oral medications.
  • 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 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 C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII SAS9Z1SVUK
    A natural oil extracted from ginger root that adds flavor and aroma to the medicine. It may also serve as a preservative or help mask unpleasant tastes in the formulation.
  • 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII B7SG5YV2SI
    A naturally occurring substance that holds water and is used as a thickener, lubricant, or stabilizer in formulations. It helps maintain product texture and can improve how the medicine feels or spreads on application.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII V1YW10H14D
    A waxy substance made from glucose and stearic acid that acts as an emulsifier and thickener in medicines, helping to blend ingredients together and create a smooth, stable texture in creams and ointments.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII QU52J3A5B3
    A plant extract from black willow bark used as a natural flavoring agent and to add medicinal plant material to the formulation. It may also help preserve the product.
  • 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 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.

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

The official label also statesAlcohol Denat, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arnica Montana Extract, Caffeine, Calendula Officinalis Flower Extract, Carbomer, Curcuma Longa (Turmeric) Root Extract, Cymbopogon Flexuosus Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Glyceryl Stearate Se, Hydrolyzed Hyaluronic Acid, Isohexadecane, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Methyl Glucose Sesquistearate, Phenoxyethanol, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Water, Zingiber Officinale (Ginger) Root Extract, Zingiber Officinale (Ginger) Root 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.

Manufacturer & labeler

LabelerRael, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code72863
First marketedOct 2024
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.

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 22 words ▾

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains.

⏱️ Dosage and Administration 34 words ▾

Directions Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor.

⚠️ Warnings 76 words ▾

Warnings For external use only When using this product avoid contact with the eyes use only as directed do not apply to wounds or damaged skin do not bandage tightly. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 13 words ▾

Other information store in a cool dry place with the lid closed tightly.

🧪 Active Ingredient 11 words ▾

Active ingredients Purpose Camphor 4% Topical analgesic Menthol 4% Topical analgesic

🧪 Inactive Ingredients 79 words ▾

Inactive ingredients Alcohol Denat, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arnica Montana Extract, Caffeine, Calendula Officinalis Flower Extract, Carbomer, Curcuma Longa (Turmeric) Root Extract, Cymbopogon Flexuosus Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Glyceryl Stearate Se, Hydrolyzed Hyaluronic Acid, Isohexadecane, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Methyl Glucose Sesquistearate, Phenoxyethanol, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Water, Zingiber Officinale (Ginger) Root Extract, Zingiber Officinale (Ginger) Root Oil

🎯 Purpose 11 words ▾

Active ingredients Purpose Camphor 4% Topical analgesic Menthol 4% Topical analgesic

📄 When Using This Product 25 words ▾

When using this product avoid contact with the eyes use only as directed do not apply to wounds or damaged skin do not bandage tightly.

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 10 words ▾

Questions? For questions and general information visit us at www.getrael.com/pages/contact

📄 Package Label / Principal Display Panel 45 words ▾

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton Rael PAIN RELIEF ROLL-ON FOR CRAMPS R Temporarily relieves PMS aches and pains FAST-ACTING 1.7 fl. oz. | 50ml MASSAGING ROLLERBALL *Not actual size 4% Camphor 4% Menthol Magnesium Principal Display Panel - 50 mL Bottle Carton

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 CAMPHOR (SYNTHETIC) and MENTHOL, UNSPECIFIED FORM — the ingredient across all brands.

Top reported reactions

Back Pain9
Nausea9
Pain9
Fatigue6
Dyspnoea5
Peripheral Swelling5
Tremor5

Age at onset

Adult1
Elderly4

Reporter sex

80 reports
Male · 22%
Female · 77%
Unknown · 1%

Serious outcomes

Hospitalization15
Disabling7
Life-threatening4
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6 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.

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 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 Rael, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rael, Inc. 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.
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.