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ICY FREEZE MENTHOL 35 mg/mL Gel

by NATURAL ESSENTIALS, INC. · 1 BOTTLE in 1 BOTTLE, PUMP (66902-165-04) / 120 mL in 1 BOTTLE
NDC 66902-0165-04
🏷️ FDA NDC (as labeled) 66902-165-04 billing pads the product segment with a zero
This package
Contains120 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 90 mL 66902-0165-03
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) 66902-165-04
Product NDC 66902-165
11-digit billing NDC 66902016504
RxCUI 808955
UNII L7T10EIP3A
UPC 0713012685133, 0713012685140
Application # part348
SPL Set ID 41b2e9a0-818d-4188-8c9d-8ff7c0d0519b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Why two NDCs? The FDA registers this code as 66902-165-04 — 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 → 66902-0165-04. 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

LabelerNATURAL ESSENTIALS, INC.
FDA applicationpart348 (OTC MONOGRAPH NOT FINAL)
Labeler code66902
First marketedDec 2017
Product typeHuman Otc Drug
Portfolio34 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 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 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 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains 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.

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

The official label also statesNon-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine. MADE IN USA for Healer Health LLC Zionsville, Indiana 46077 TM Reg'd 85140-L ICYFREEZE.COM

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: 90 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
Elgin Pain Relief 35 mg/g 30056-0004-03 Eco-Logics, 85 g — — FDA listed —
Arctic Relief 3.969 g/113.4g 58980-0615-40 STRATUS 1 tube — — FDA listed —
Biofreeze 35 mg/mL 59316-0101-10 Reckitt 5 ml — — FDA listed —
PERFORM COOL and SOOTHING PAIN RELIEVING 35 mg/mL 59316-0111-10 Reckitt 3 ml — — Discontinued —
Perform Cool And Soothing Pain Relieving Roll-On 35 mg/mL 59316-0112-10 Reckitt 1 bottle — — FDA listed —
Muscle 3.5 g/100mL 59898-0805-05 WATER-JEL 96 packets — — FDA listed —
Fast Freeze 35 mg/g 66902-0016-01 Natural 1 g — — FDA listed —
Icy Freeze 35 mg/mLthis 66902-0165-04 NATURAL 1 bottle — — FDA listed —
FREEZE IT Menthol 3.5 g/100g 71726-0004-02 LiquidCapsule 113.4 g — — FDA listed —
FREEZE IT Menthol Roll On 3.5 g/100mL 71726-0005-01 LiquidCapsule 89 ml — — FDA listed —
ORTHOGEL Menthol 3.5% 3.5 g/100g 71726-0007-02 LiquidCapsule 113.4 g — — FDA listed —
ORTHOGEL Menthol 3.5% Roll On 3.5 g/100mL 71726-0008-01 LiquidCapsule 89 ml — — FDA listed —
AcuPlus Pain Relief 35 mg/mL 72037-0135-01 Innovations 3785 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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 ICY FREEZE (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
2019 2021 2023 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
66902-0165-03 1 BOTTLE in 1 BOTTLE, WITH APPLICATOR (66902-165-03) / 90 mL in 1 BOTTLE 2017-12-01 Active
66902-0165-04 You're viewing this 1 BOTTLE in 1 BOTTLE, PUMP (66902-165-04) / 120 mL in 1 BOTTLE 2017-12-01 Active

Pack size FAQ

What quantity is in NDC 66902-0165-04?
NDC 66902-0165-04 is listed by the FDA — 1 bottle in 1 bottle, pump / 120 ml in 1 bottle.
What NDC number is used to bill for this package of ICY FREEZE MENTHOL 35 mg/mL Gel?
Bill NDC 66902-0165-04 — the 11-digit billing format is 66902016504. 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 — 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 Not Final". 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 66902-165-04, 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: 66902-0165-04, written without dashes as 66902016504. 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 66902-0165-04, the first segment (66902) is the labeler code FDA assigned to NATURAL ESSENTIALS, INC.; the middle segment (0165) 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.
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 NATURAL ESSENTIALS, 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 1 other package presentation of this same product, including 1 bottle (66902-0165-03). 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?
NATURAL ESSENTIALS, 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 18 words ▾

Uses Temporary relief from minor aches and pains associated with: Tendonitis Strains Sprains Sore muscles Joint discomfort Arthritis

⏱️ Dosage and Administration 25 words ▾

Directions Adults/Children 2 years and older: Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

⚠️ Warnings 195 words ▾

Warnings For external use only Flammable Keep away from excessive heat or open flame Do not use With heating pad or device With creams, ointments, sprays or liniments On wounds, damaged skin or irritated skin Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding When using this product Avoid contact with eyes or mucous membranes Do not bandage tightly Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up then reoccur again within a few days Irritation develops Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Directions Adults/Children 2 years and older: Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes Children under 2 years old: Application should be supervised by an adult. Other information Replace cap after use Store in a cool, dry place.

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine. MADE IN USA for Healer Health LLC Zionsville, Indiana 46077 TM Reg'd 85140-L ICYFREEZE.COM

🧪 Active Ingredient 4 words ▾

Active ingredient Menthol 3.5%

🧪 Inactive Ingredients 35 words ▾

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine. MADE IN USA for Healer Health LLC Zionsville, Indiana 46077 TM Reg'd 85140-L ICYFREEZE.COM

🎯 Purpose 4 words ▾

Purpose Cooling Pain Relief

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 66902-0142-63 · Natural 66902-0166-34 · Natural →
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.