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Real Time Pain Relief Maxx Plus Topical Analgesic MENTHOL 19 mg/mL Lotion, 210 mL — NDC 84573-0547-07 package photo

Real Time Pain Relief Maxx Plus Topical Analgesic MENTHOL 19 mg/mL Lotion, 210 mL

by Real Time Products Inc. · 210 mL in 1 TUBE (84573-547-07)
NDC 84573-0547-07
🏷️ FDA NDC (as labeled) 84573-547-07 billing pads the product segment with a zero
This package
Contains210 mL Pack sizes6 compare ↓
Also comes in: 88 ml 84573-0547-03 120 ml 84573-0547-04 147.8 ml 84573-0547-05 354 ml 84573-0547-12 473 ml 84573-0547-16
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

⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 84573-547-07
Product NDC 84573-547
11-digit billing NDC 84573054707
UNII L7T10EIP3A
UPC 0810042761100, 0810042760967, 0810042761070, 0810042761094 +2 more
Application # M017
SPL Set ID fc509a55-594d-4d44-87db-33286e937581
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-23
Route TOPICAL
Dosage form LOTION
Substance MENTHOL
Why two NDCs? The FDA registers this code as 84573-547-07 — 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 → 84573-0547-07. 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

LabelerReal Time Products Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code84573
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 Read our full Menthol guide →

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 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 E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII S07O44R1ZM
    Capsaicin is a pungent compound from chili peppers. In topical medicines, it acts as an active warming or heat-producing agent rather than a traditional inactive ingredient, creating localized skin sensation.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII 7626GC95E5
    A natural aromatic oil extracted from coriander seeds. Used as a flavoring agent to mask bitter tastes and improve the overall taste of medicines, making them easier to take.
  • 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 344821WD61
    Emu oil is a natural fat derived from emu birds, used in some medicines as an emollient and penetration enhancer to help active ingredients absorb through the skin and soften the formulation.
  • UNII 1FW7WLR731
    Glucosamine sulfate is a natural compound derived from shellfish or made in laboratories. In medications, it acts as an active therapeutic ingredient rather than an inactive excipient, though it may also serve as a filler or binder in some 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 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 Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • 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 205MXS71H7
    A plant extract from white willow bark. It's used as a natural flavoring agent and may help preserve the medicine by providing mild antioxidant properties in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII UFH8805FKA
    St. John's Wort is a plant extract used as an inactive ingredient in some dietary supplements and herbal formulations. It's included primarily for its traditional herbal content rather than as a structural component like binders or fillers.
  • 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 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.

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

The official label also states*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Cannabis Sativa (Hemp)Seed Oil, Caprylyl Glycol, Capsaicin, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Chondroitin Sulfate, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Glucosamine Sulfate, Glycerin, Hamamelis Virginiana (Witch Hazel), Hypericum Perforatum (St. John's Wort) Extract, C13-14 Isoparaffin, Laureth-7, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sorbitol, Tilia Cordata (Linden) Bark Extract. *Denotes certified organic ingredient.

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: 88 ml 120 ml 147.8 ml 354 ml 473 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
Real Time Pain Relief Maxx Plus Topical Analgesic 19 mg/mLthis 84573-0547-07 Real 210 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
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.

🔬 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 Real Time Pain Relief Maxx Plus Topical Analgesic (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

989 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization333
Death125
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 96 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
84573-0547-03 88 mL in 1 TUBE (84573-547-03) 2024-10-23 Active
84573-0547-04 120 mL in 1 TUBE (84573-547-04) 2024-10-23 Active
84573-0547-05 147.8 mL in 1 TUBE (84573-547-05) 2024-10-23 Active
84573-0547-07 You're viewing this 210 mL in 1 TUBE (84573-547-07) 2024-10-23 Active
84573-0547-12 354 mL in 1 BOTTLE (84573-547-12) 2024-10-23 Active
84573-0547-16 473 mL in 1 BOTTLE (84573-547-16) 2024-10-23 Active

Pack size FAQ

What quantity is in NDC 84573-0547-07?
NDC 84573-0547-07 contains 210 mL — 210 ml in 1 tube.
What is the difference between NDC 84573-0547-07 and NDC 84573-0547-03?
Both are Real Time Pain Relief Maxx Plus Topical Analgesic MENTHOL 19 mg/mL Lotion — the drug itself is identical. NDC 84573-0547-07 is the 210 mL package, while NDC 84573-0547-03 is the 88 ml package.
What NDC number is used to bill for this package of Real Time Pain Relief Maxx Plus Topical Analgesic MENTHOL 19 mg/mL Lotion?
Bill NDC 84573-0547-07 — the 11-digit billing format is 84573054707. 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 84573-547-07, 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: 84573-0547-07, written without dashes as 84573054707. 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 84573-0547-07, the first segment (84573) is the labeler code FDA assigned to Real Time Products Inc.; the middle segment (0547) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Real Time Products Inc.. 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 5 other package presentations of this same product, including 88 ml (84573-0547-03), 120 ml (84573-0547-04), 147.8 ml (84573-0547-05). 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?
Real Time Products 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.

📄 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 15 words ▾

Uses: Temporarily relieves minor pain associated with: Arthritis Simple Backache Muscle Strains Sprains Bruises Cramps

⏱️ Dosage and Administration 38 words ▾

Directions: Adults and Children over 2 years: Apply to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more than 4 times daily. Children 2 years or younger: ask a doctor.

⚠️ Warnings 82 words ▾

Warnings: For external use only When using this product: Use only as directed Avoid contact with eyes or mucous membranes 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 Redness is present Irritation develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words ▾

Active Ingredient Menthol 1.9% Purpose Topical Analgesic

🧪 Inactive Ingredients 84 words ▾

Other Ingredients: *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Cannabis Sativa (Hemp)Seed Oil, Caprylyl Glycol, Capsaicin, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Chondroitin Sulfate, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Glucosamine Sulfate, Glycerin, Hamamelis Virginiana (Witch Hazel), Hypericum Perforatum (St. John's Wort) Extract, C13-14 Isoparaffin, Laureth-7, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sorbitol, Tilia Cordata (Linden) Bark Extract. *Denotes certified organic ingredient.

🎯 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 ↗
← 84573-0517-03 · REAL 84577-0750-01 · Celcuity →
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.