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Cold Therapy Menthol 10 g/100mL Gel, 126 mL — NDC 68678-0011-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cold Therapy Menthol 10 g/100mL Gel, 126 mL — NDC 68678-011-05 (Billing 68678-0011-05)

by AHC VENTURES CORP DBA CRYODERM · 126 mL in 1 BOTTLE, DISPENSING

This is a package of 126 mL of Cold Therapy Menthol 10 g/100mL Gel from AHC VENTURES CORP DBA CRYODERM, marketed since Jan 2016 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 68678-0011-05
🏷️ FDA NDC (as labeled) 68678-011-05 billing pads the product segment with a zero
This package
Contains126 mL Pack sizes3 compare ↓
Main listing for product 68678-011 · Also comes in: 3 ml 68678-011-99 504 ml 68678-011-17
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 68678-011-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68678 labeler · 011 product · 05 package
Package marketed since
Jan 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0855954002033
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) 68678-011-05
Product NDC 68678-011
11-digit billing NDC 68678001105
RxCUI 259249
UNII L7T10EIP3A
UPC 0855954002033
Application # M017
SPL Set ID 90334420-5f81-4284-9a57-42e134ce362f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 259249
Why two NDCs? The FDA registers this code as 68678-011-05 — 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 → 68678-0011-05. 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: 3 ml 504 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68678-0011-05 You're viewing this Main listing 126 mL in 1 BOTTLE, DISPENSING 2016-01-01 — Active
68678-0011-17 68678-011-17 504 mL in 1 BOTTLE, DISPENSING 2016-01-01 — Active
68678-0011-99 68678-011-99 3 mL in 1 PACKET 2016-01-01 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 126 mL — 126 ml in 1 bottle, dispensing.
How does this package differ from NDC 68678-0011-99?
Both are Cold Therapy Menthol 10 g/100mL Gel — the drug itself is identical. This page's package is the 126 mL one, while NDC 68678-0011-99 is the 3 ml package.
What NDC number is used to bill for this package of Cold Therapy Menthol 10 g/100mL 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
Xpect Stopain Clinical 100 mg/g 42961-0256-01 Cintas 3 g — — FDA listed —
K2 Cold Therapy 10 g/100mL 54633-0414-03 The 88.72 ml — — FDA listed —
Stopain Clinical 100 mg/g 63936-0975-05 Troy 5 g — — FDA listed —
Stopain Clinical 100 mg/mL 63936-9505-05 Troy 50 ml — — FDA listed —
Stopain Clinical Roll-On 100 mg/mL 63936-9520-01 Troy 88 ml — — FDA listed —
Ralli Rapid Pain Relief Roll on 100 mg/mL 63936-9527-01 Troy 88 ml — — FDA listed —
Stopain Clinical 100 mg/mL 63936-9750-01 Troy 3785 ml — — FDA listed —
Stopain Clinical 100 mg/g 63936-9751-01 Troy 12 packets — — FDA listed —
Ralli Rapid Pain Relief 100 mg/mL 63936-9752-01 Troy 88 ml — — FDA listed —
Ralli Rapid Pain Relief 100 mg/g 63936-9753-02 Troy 3 g — — FDA listed —
Stopain Clinical 100 mg/g 63936-9758-01 Troy 3 g — — FDA listed —
Cold Therapy 10 g/100mLthis 68678-0011-05 AHC 126 ml — — FDA listed —
Cold Therapy 10 g/100mL 68678-0013-90 AHC 95 ml — — FDA listed —
Cryo10 Topical Analgesic 100 mg/mL 83549-0000-01 Element 88 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

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 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.

What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

  • 0.004 mL / 100 mL UNII XH2FQZ38D8
    A plastic-like coating material made from long-chain fatty acids and acrylic compounds. It forms a protective film on tablets or capsules to control how fast the medicine dissolves and is absorbed in your digestive system.
  • 48.4 mL / 100 mL UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 1 mL / 100 mL UNII O80TY208ZW
    Arnica montana is a plant extract used in some formulations as a flavoring agent or traditional botanical ingredient. It may contribute mild taste or aroma to the product.
  • 1 mL / 100 mL UNII X7B7P649WQ
    A plant extract from boswellia serrata tree resin, used as a natural filler and binding agent in capsules and tablets to add bulk and help hold the formulation together.
  • 0.03 mL / 100 mL 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.
  • 0.05 mL / 100 mL UNII RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • 5 mL / 100 mL 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.
  • 1 mL / 100 mL 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.
  • 0.05 mL / 100 mL 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.
  • 0.5 mL / 100 mL 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.
  • 32.906 mL / 100 mL 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.

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

The official label also statesAcrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, 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

LabelerAHC VENTURES CORP DBA CRYODERM
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code68678
First marketedJan 2016
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from AHC VENTURES CORP DBA CRYODERM labeler code 68678

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 ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses Temporary relieves minor aches and pains associated with sore muscles and joints arthritis backache muscle strains sprains bruises

⚠️ Warnings 5 words ▾

Warnings: For external use only

🧪 Active Ingredient 5 words ▾

Active Ingredient Menthol USP 10.0%

🧪 Inactive Ingredients 23 words ▾

Inactive Ingredients: Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

🎯 Purpose 3 words ▾

Purpose Pain Reliever

📄 When Using This Product 52 words ▾

When using this product: Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask doctor if: Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops

🤰 If Pregnant or Breast-Feeding 11 words ▾

If Pregnant or Breast Feeding: Ask a health professional before use

📄 Keep Out of Reach of Children 21 words ▾

Keep Out of Reach of Children: In case of accidental ingestion get medical help or contact a Poison Control Center immediately

📄 Other Information 23 words ▾

Other Information Store in a cool dry place with lid or cap closed tightly Flammable: Keep away from excessive heat or open flame

📖 Instructions for Use 42 words ▾

Directions: Adults and children 2 years and older: Apply directly onto afected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily. Children under 2 years of age: Consult a Physician

📄 Package Label / Principal Display Panel 44 words ▾

PDP CryoDerm Pain Relieving Cold Therapy Gel Fast Acting, Penetrating Pain Relief For: Muscle Strains, Joint Pain, Backache, Arthritis, Sprained Ligaments & Bruises. Contains Essential Oils and Natural Extracts MSM Arnica Boswellia Ilex Active Ingredient: Menthol 4 fl. oz. 126mL 4 oz cold gel

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 Cold Therapy (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

990 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.

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 AHC VENTURES CORP DBA CRYODERM. 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 2 other package presentations of this same product, including 3 ml (68678-0011-99), 504 ml (68678-0011-17). 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?
AHC VENTURES CORP DBA CRYODERM 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.
← 68645-0613-90 · Legacy 68678-0012-04 · AHC →
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.