POMG PAIN RELIEF ROLLER Lidocaine Hydrochloride, Menthol 50 mg/mL; 40 mg/mL Gel, 90 mL
by POMG LLC · 90 mL in 1 BOTTLE, WITH APPLICATOR (84615-004-03)
NDC 84615-0004-03
🏷️ FDA NDC (as labeled)
84615-004-03
billing pads the product segment with a zero
This package
Contains90 mL
Pack sizes2 compare ↓
Also comes in:
59 mL 84615-0004-02
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
84615-004-03
Product NDC
84615-004
11-digit billing NDC
84615000403
RxCUI
2690870
UNII
L7T10EIP3A, V13007Z41A
UPC
0198168366929
Application #
M017
SPL Set ID
1fa980fb-fc0e-fdd0-e063-6394a90adc13
Established class (EPC)
Amide Local Anesthetic; Antiarrhythmic
Physiologic effect
Local Anesthesia
Chemical class
Amides
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-08-14
Route
TOPICAL
Dosage form
GEL
Substance
MENTHOL; LIDOCAINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 84615-004-03 — 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 → 84615-0004-03. 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.
🏷️ RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
Pharmacologic class
Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC)
Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerPOMG LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code84615
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio3 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?
POMG Pain Relief Roller is a topical gel applied directly to the skin using a roll-on applicator. It contains lidocaine hydrochloride and menthol as active ingredients. Lidocaine is a local anesthetic commonly used to numb or reduce sensation in the area where it is applied, while menthol is typically used for its cooling sensation and to provide temporary relief of minor aches and pains. This product is marketed as an over-the-counter monograph drug, meaning it follows established FDA guidelines for this category of topical pain relief products.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Lidocaine Hydrochloride, Menthol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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 OZ0E5Y15PZ
A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
-
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.
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UNII 00UK7646FG
Capsicum is a natural plant extract from red peppers. It's used as a colorant and flavoring agent to give medicines their red or orange appearance and mild spicy taste.
-
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 9M44R3409A
A modified corn starch where some starch molecules have hydroxypropyl groups attached. It's used as a binder and disintegrant to help hold tablet ingredients together and allow the tablet to break apart properly when swallowed.
-
UNII 02F3473H9O
A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesreverse osmosis water, organic aloe juice, magnesium chloride flakes, msm (methylsulfonylmethane), hydroxypropyl starch phosphate, organic arnica (co2 extract), organic calendula (co2 extract), organic capsicum (co2 extract)
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 system | Per g | Per 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:
59 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pomg Pain Relief Roller 50 mg/mL; 40 mg/mLthis 84615-0004-03 | POMG | 90 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
🏛️
2024
On the market since
Aug 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.
🔬 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 Lidocaine Hydrochloride, Menthol — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 67%
Female · 33%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 84615-0004-02 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (84615-004-02) / 59 mL in 1 BOTTLE, WITH APPLICATOR | 2024-08-14 | Active |
| 84615-0004-03 You're viewing this | 90 mL in 1 BOTTLE, WITH APPLICATOR (84615-004-03) | 2024-08-14 | Active |
Pack size FAQ
What quantity is in NDC 84615-0004-03?
NDC 84615-0004-03 contains 90 mL — 90 ml in 1 bottle, with applicator.
What NDC number is used to bill for this package of POMG PAIN RELIEF ROLLER Lidocaine Hydrochloride, Menthol 50 mg/mL; 40 mg/mL Gel?
Bill NDC 84615-0004-03 — the 11-digit billing format is 84615000403. 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 84615-004-03, 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: 84615-0004-03, written without dashes as 84615000403. 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 84615-0004-03, the first segment (84615) is the labeler code FDA assigned to POMG LLC; the middle segment (0004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 POMG LLC. 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 1 bottle (84615-0004-02). 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?
POMG 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 ▾
Use For temporary relief of pain in muscles, joints, and tendons
⏱️ Dosage and Administration ▾
Directions • Adults and children 12 years of age and older: rub a thin film over desired area not more than 3 to 4 times daily • Children under 12 years of age: consult a doctor • Wash hands after use with soap and water
⚠️ Warnings ▾
Warnings For external use only Do not use • If you are allergic to any ingredients in this product • On open sores and wounds • In large quantities When using this product • Use only as directed • Do not bandage tightly • Avoid contact with eyes and other mucous membranes • Do not expose the area to external heat or direct sunlight Stop use and consult a doctor if • Conditions worsen or symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days • Redness is present or excessive skin irritation occurs • You experience severe burning pain, swelling, or blistering where product was applied • Allergic reaction occurs • If pregnant or breast-feeding, consult a doctor before use • Keep out of reach of children and pets.
If swallowed, get medical help or contact Poison Control Center right away
🧪 Active Ingredient ▾
Active Ingredients Lidocaine HCl 4% Menthol 5%
🧪 Inactive Ingredients ▾
reverse osmosis water, organic aloe juice, magnesium chloride flakes, msm (methylsulfonylmethane), hydroxypropyl starch phosphate, organic arnica (co2 extract), organic calendula (co2 extract), organic capsicum (co2 extract)
🎯 Purpose ▾
Purpose Lidocaine HCl 4% ……….…Topical Anesthetic Menthol 5% ………………... Pain Relief
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.