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Fast Freeze Menthol 35 mg/g Gel, 1 g — NDC 66902-0016-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fast Freeze Menthol 35 mg/g Gel, 1 g — NDC 66902-016-01 (Billing 66902-0016-01)

by Natural Essentials Inc. · 1 g in 1 BOTTLE, PUMP

This is a package of 1 g of Fast Freeze Menthol 35 mg/g Gel from Natural Essentials Inc., marketed since Jan 2013 and currently FDA-listed. It is the main listing for this product, which comes in 6 package sizes.

NDC 66902-0016-01
🏷️ FDA NDC (as labeled) 66902-016-01 billing pads the product segment with a zero
This package
Contains1 g Pack sizes6 compare ↓
Main listing for product 66902-016 · Also comes in: 1 g 66902-016-03 1 g 66902-016-04 1 g 66902-016-05 1 g 66902-016-16 1 g 66902-016-32
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 66902-016-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
66902 labeler · 016 product · 01 package
Package marketed since
Jan 1, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0038481009632
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) 66902-016-01
Product NDC 66902-016
11-digit billing NDC 66902001601
RxCUI 808955, 1365998
UNII L7T10EIP3A
UPC 0038481009632
Application # M017
SPL Set ID a96e3e41-871c-4cf3-93b6-af2a6246ded8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-01-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 808955
Why two NDCs? The FDA registers this code as 66902-016-01 — 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 → 66902-0016-01. 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.
Try another pack size: 1 g 1 g 1 g 1 g 1 g
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
66902-0016-01 You're viewing this Main listing 1 g in 1 BOTTLE, PUMP 2013-01-01 — Active
66902-0016-03 66902-016-03 1 g in 1 BOTTLE 2013-01-01 — Active
66902-0016-04 66902-016-04 1 g in 1 TUBE 2013-01-01 — Active
66902-0016-05 66902-016-05 1 g in 1 PACKET 2013-01-01 — Active
66902-0016-16 66902-016-16 1 g in 1 BOTTLE, PUMP 2013-01-01 — Active
66902-0016-32 66902-016-32 1 g in 1 BOTTLE, PUMP 2013-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 g — 1 g in 1 bottle, pump.
How does this package differ from NDC 66902-0016-03?
Both are Fast Freeze Menthol 35 mg/g Gel — the drug itself is identical. This page's package is the 1 g one, while NDC 66902-0016-03 is the 1 g package.
What NDC number is used to bill for this package of Fast Freeze Menthol 35 mg/g Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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/gthis 66902-0016-01 Natural 1 g — — FDA listed —
Icy Freeze 35 mg/mL 66902-0165-03 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 —
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

🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • 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 statesAloe Barbadensis (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, Water.

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

LabelerNatural Essentials Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code66902
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from Natural Essentials Inc. labeler code 66902

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses Temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Sprains

⏱️ Dosage and Administration 31 words ▾

Directions Adults/Children 2 years and older: Roll on the affected area not more than 3 to 4 times daily Shake well before use Children under 2 years old: Consult a physician.

⚠️ Warnings 111 words ▾

Warnings For external use only Flammable Keep away from excessive heat or open flame Do not use With heating pad or device With ointments, creams, 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.

🧪 Active Ingredient 4 words ▾

Active ingredients Menthol 3.5%

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients Aloe Barbadensis (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, Water.

🎯 Purpose 4 words ▾

Purpose Cooling Pain Relief

📄 Do Not Use 21 words ▾

Do not use With heating pad or device With ointments, creams, sprays or liniments On wounds, damaged skin or irritated skin

📄 Ask a Doctor Before Use If 14 words ▾

Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding

📄 When Using This Product 15 words ▾

When using this product Avoid contact with eyes or mucous membranes Do not bandage tightly

📄 Stop Use and Ask a Doctor If 28 words ▾

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 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 8 words ▾

Questions? Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

📄 Package Label / Principal Display Panel 50 words ▾

Principal Display Panel – Bottle Label FAST FREEZE ® Naturally Cool Pain Relieving Roll-On Helps to relieve Sore muscles Strains & sprains Joint pain …………………………………. Invigorating cooling menthol Greaseless & stain-free Natural ingredients include Vitamin E, Aloe & llex …………………………………. 3 oz (89 mL) Principal Display Panel – Bottle Label

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 Menthol — the ingredient across all brands.

Top reported reactions

Pain3,545
Fatigue3,324
Nausea3,269
Headache3,025
Dyspnoea2,471
Diarrhoea2,208
Pneumonia2,151

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,728 2,446
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 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 5 other package presentations of this same product, including 1 g (66902-0016-03), 1 g (66902-0016-04), 1 g (66902-0016-05). 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?
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.
← 66902-0015-04 · Natural 66902-0037-25 · 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.