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Hielo Ardiente Menthol 1 g/100g Gel, 454 g — NDC 53145-0002-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hielo Ardiente Menthol 1 g/100g Gel, 454 g — NDC 53145-002-01 (Billing 53145-0002-01)

by Menper Distributors, Inc. · 454 g in 1 JAR

This is a package of 454 g of Hielo Ardiente Menthol 1 g/100g Gel from Menper Distributors, Inc., marketed since Feb 2012 and currently FDA-listed. It is this product's only package size.

NDC 53145-0002-01
🏷️ FDA NDC (as labeled) 53145-002-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53145-002-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53145 labeler · 002 product · 01 package
Package marketed since
Feb 21, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0042279419169
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53145-002-01
Product NDC 53145-002
11-digit billing NDC 53145000201
RxCUI 1039043
UNII L7T10EIP3A
UPC 0042279419169
Application # M017
SPL Set ID 97ec516c-d2bc-47ce-82fe-bd68445d9570
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-02-21
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 1039043
Why two NDCs? The FDA registers this code as 53145-002-01 — 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 → 53145-0002-01. 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

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 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.

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.
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
53145-0002-01 You're viewing this Main listing 454 g in 1 JAR 2012-02-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hielo Ardiente 1 g/100gthis 53145-0002-01 Menper 454 g — — FDA listed —
Keracare 10 mg/g 63766-0001-01 Avlon 110 g — — FDA listed —
Pharmacys Prescription Analgesic Gel 1 g/100g 72197-0001-08 American 227 g — — FDA listed —
Numbing Cream 1 g/100g 85524-2519-02 FlexiGo 1 bottle — — FDA listed —
Aromalief Pain Relief Cream Orange Ginger 1 g/100g 72393-0301-02 Marketites 07 g — — FDA listed —
Aromalief Calming Pain Relief Cream Lavender 1 g/100g 72393-0302-02 Marketites 07 g — — FDA listed —
Health Trak Plus Menthol-Infused Pain Relief Socks 1 g/100g 85720-8131-01 Railroad 1 g — — FDA listed —
Yynrhj Numbing Creams 1 g/100g 85593-0005-01 Guangzhou 60 g — — Discontinued —
Ching Wan Hung Soothing Herbal Balm 1 g/100g 33217-0001-01 TIANJIN 10 g — — FDA listed —
Aromalief Cozy Vanilla Pain Relief Cream 1 g/100g 72393-0303-04 Marketites 14 g — — FDA listed —
Olelon Numbing 1 g/100g 85593-0018-01 Guangzhou 120 g — — Discontinued —
YYNRHI NUMBING Creams 1 g/100g 85593-0004-01 Guangzhou 60 g — — Discontinued —
Global Care Ice Cold Analgesic 1 g/100g 76176-0162-01 NINGBO 227 g — — FDA listed —
Global Care Ice Cold Analgesic 1 g/100g 72146-0009-01 GLOBAL 227 g — — 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

🏛️
2012
On the market since
Feb 2012
📍
2026
Currently FDA-listed
14 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.

🧪 Avoiding an ingredient? See Menthol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII DEL7T5QRPN
    A synthetic preservative that kills bacteria and fungi. It's added to medications to prevent microbial growth and extend shelf life, especially in liquid or topical formulations.
  • UNII 229D0E1QFA
    Methylisothiazolinone is a synthetic chemical preservative that prevents bacterial and fungal growth in liquid medicines and topical products. It helps keep the medication safe and extends shelf life during storage.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII M3EN4GC19W
    Triethanolamine benzoate is a chemical compound made from triethanolamine combined with benzoic acid. In medicines, it typically works as a preservative to prevent bacterial and fungal growth, and may also help adjust the pH balance of liquid formulations.
  • 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.

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

The official label also statesInactive ingredients camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, polysorbate 20, purified water, 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.

Manufacturer & labeler

LabelerMenper Distributors, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code53145
First marketedFeb 2012
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Menper Distributors, Inc. labeler code 53145

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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

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

⏱️ Dosage and Administration 48 words ▾

Directions Adults and children 12 years of age or older: Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs.

⚠️ Warnings 57 words ▾

Warnings For external use only Avoid contact with eyes Do not use if condition worsens If symptoms persist for more than 5 days or recur, discontinue use and consult a physician Do not apply to open wounds or damaged skin Do not bandage tightly Do not use with heating pads or heating devices Use only as directed

🧪 Active Ingredient 4 words ▾

Active ingredient Menthol 1%

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, polysorbate 20, purified water, triethanolamine

🎯 Purpose 2 words ▾

Purpose Analgesic

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, contact a doctor or a Poison Control Center right away.

📄 Package Label / Principal Display Panel 1 words ▾

Hielo

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 Hielo Ardiente (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
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 109 74
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 ✓ 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 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 Menper Distributors, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Menper Distributors, 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.
← 53129-0025-00 · Daiichi 53145-0004-01 · Menper →
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.