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Point Relief Cold Spot Pain Relieving MENTHOL 120 mg/mL Gel, 420 mL — NDC 51452-0035-04 package photo

Point Relief Cold Spot Pain Relieving MENTHOL 120 mg/mL Gel, 420 mL

by Fabrication Enterprises · 420 mL in 1 TUBE (51452-035-04)
NDC 51452-0035-04
🏷️ FDA NDC (as labeled) 51452-035-04 billing pads the product segment with a zero
This package
Contains420 mL Pack sizes5 compare ↓
Also comes in: 120 ml 51452-0035-01 475 ml 51452-0035-02 950 ml 51452-0035-05 3800 ml 51452-0035-03
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 51452-035-04
Product NDC 51452-035
11-digit billing NDC 51452003504
RxCUI 2121666
UNII L7T10EIP3A
UPC 0714905025104, 0714905025074, 0714905024305, 0714905031105 +1 more
Application # M017
SPL Set ID ad5d6f04-15e6-4548-95c2-32271c186bc1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2019-04-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Why two NDCs? The FDA registers this code as 51452-035-04 — 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 → 51452-0035-04. 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

LabelerFabrication Enterprises
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code51452
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio5 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 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 U182GP2CF3
    Bromelain is an enzyme derived from pineapple plants that breaks down proteins. In medications, it acts as a disintegrant, helping tablets or capsules break apart and release their active ingredients more quickly in the digestive system.
  • 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 H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII 1Q953B4O4F
    Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
  • UNII 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesaqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

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: 120 ml 475 ml 950 ml 3800 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
Point Relief Cold Spot Pain Relieving 120 mg/mLthis 51452-0035-04 Fabrication 420 ml — — Discontinued —
Point Relief Cold Spot Pain Relieving 120 mg/g 51452-0036-06 Fabrication 5 g — — FDA listed —
POINT RELIEF COLD SPOT Pain Relieving 120 mg/mL 51452-0450-01 FABRICATION 3800 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 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 Point Relief Cold Spot Pain Relieving (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Reporter sex

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

Serious outcomes

Hospitalization333
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 109 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
51452-0035-01 120 mL in 1 BOTTLE (51452-035-01) 2019-04-01 Discontinued by firm
51452-0035-02 475 mL in 1 BOTTLE (51452-035-02) 2019-04-01 Active
51452-0035-03 3800 mL in 1 JUG (51452-035-03) 2019-04-01 Active
51452-0035-04 You're viewing this 420 mL in 1 TUBE (51452-035-04) 2019-04-01 Discontinued by firm
51452-0035-05 950 mL in 1 BOTTLE (51452-035-05) 2019-04-01 Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 51452-0035-04?
NDC 51452-0035-04 contains 420 mL — 420 ml in 1 tube.
What is the difference between NDC 51452-0035-04 and NDC 51452-0035-01?
Both are Point Relief Cold Spot Pain Relieving MENTHOL 120 mg/mL Gel — the drug itself is identical. NDC 51452-0035-04 is the 420 mL package, while NDC 51452-0035-01 is the 120 ml package.
What NDC number is used to bill for this package of Point Relief Cold Spot Pain Relieving MENTHOL 120 mg/mL Gel?
Bill NDC 51452-0035-04 — the 11-digit billing format is 51452003504. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 51452-035-04, 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: 51452-0035-04, written without dashes as 51452003504. 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 51452-0035-04, the first segment (51452) is the labeler code FDA assigned to Fabrication Enterprises; the middle segment (0035) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 120 ml (51452-0035-01), 475 ml (51452-0035-02), 950 ml (51452-0035-05). 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?
Fabrication Enterprises 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 24 words ▾

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

⏱️ Dosage and Administration 15 words ▾

Directions: Apply directly to affected area. Do not use more than four fimes per day.

⚠️ Warnings 45 words ▾

Warnings: For external use only Avoid contact with eyes Do not apply to open wounds or damaged skin If symptoms persist for more than sevan days, discontinue use and consult physician Keep out of reach of children If swallowed, consult physician Do not bandage tightly

🧪 Active Ingredient 9 words ▾

Active Ingredients: menthol - USP 12% Purpose: external analgesic

🧪 Inactive Ingredients 47 words ▾

Other Ingredients: aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

🎯 Purpose 3 words ▾

Purpose: external analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51452-0007-00 · Fabrication 51452-0036-06 · Fabrication →
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.