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Mineral Ice Pain Relieving Menthol 20 mg/g Gel, 226.8 g — NDC 00316-0226-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mineral Ice Pain Relieving Menthol 20 mg/g Gel, 226.8 g — NDC 0316-0226-08 (Billing 00316-0226-08)

by Crown Laboratories · 226.8 g in 1 JAR

This is a package of 226.8 g of Mineral Ice Pain Relieving Menthol 20 mg/g Gel from Crown Laboratories, marketed since Nov 2011 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 00316-0226-08
🏷️ FDA NDC (as labeled) 0316-0226-08 billing pads the labeler segment with a zero
This package
Contains226.8 g Pack sizes3 compare ↓
Main listing for product 0316-0226 · Also comes in: 99.2 g 0316-0226-35 453.6 g 0316-0226-16
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 0316-0226-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0316 labeler · 0226 product · 08 package
Package marketed since
Dec 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
227 g per package
Barcode (UPC-A, from the NDC)
3 0316022608 3
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) 0316-0226-08
Product NDC 0316-0226
11-digit billing NDC 00316022608
NCPDP billing unit GM — per gram (weight)
RxCUI 311502, 692869
UNII L7T10EIP3A
Application # M017
SPL Set ID 7b30076a-0af6-2f74-e053-2a91aa0ae08d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-11-01
Route TOPICAL
Dosage form GEL
Substance MENTHOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90070060004010
GPI class Mineral Ice
GCN Seq No 031061
GCN 48059
HICL code 002608
Ingredient (HICL) Menthol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name THERAPEUTIC MINERAL ICE 2% GEL
FDB brand name Therapeutic Mineral Ice
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 031061
  • GCN: 48059
  • GPI-14 (Medi-Span): 90070060004010
  • HICL (First Databank): 002608
  • AHFS class code: 84:92.00.00
  • RxCUI (RxNorm): 311502
Why two NDCs? The FDA registers this code as 0316-0226-08 — a 4-4-2 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 labeler segment → 00316-0226-08. 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

Label name THERAPEUTIC MINERAL ICE 2% GEL Ingredient Menthol
📗 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: 99.2 g 453.6 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
00316-0226-08 You're viewing this Main listing 226.8 g in 1 JAR 2018-12-01 — Active
00316-0226-16 0316-0226-16 453.6 g in 1 JAR 2018-12-01 — Active
00316-0226-35 0316-0226-35 99.2 g in 1 JAR 2018-12-01 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 226.8 g — 226.8 g in 1 jar.
How does this package differ from NDC 00316-0226-35?
Both are Mineral Ice Pain Relieving Menthol 20 mg/g Gel — the drug itself is identical. This page's package is the 226.8 g one, while NDC 00316-0226-35 is the 99.2 g package.
What NDC number is used to bill for this package of Mineral Ice Pain Relieving Menthol 20 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
Rugby Ice Blue External Analgesic 20 mg/g 00536-1061-39 Rugby 226.8 g $0.010 — Availability likely —
Leader Ice Blue Analgesic 20 mg/g 70000-0260-01 Cardinal 226.8 g $0.010 — Availability likely —
Mineral Ice Pain Relieving 20 mg/gthis 00316-0226-08 Crown 226.8 g — — FDA listed —
Walgreens Ice Blue Pain Relieving Topical Analgesic 20 mg/g 00363-6330-01 Walgreen 226.8 g — — FDA listed —
Menthol Pain Relieving Gel 4.54 g/227g 13709-0357-01 NeilMed 1 tube — — FDA listed —
Avedana Cool Hot Ice 2 g/100g 43749-0321-08 Unipack, 227 g — — FDA listed —
MedPride Cold Ice Analgesic Gel 4.54 g/227g 52410-3021-02 SHIELD 227 g — — FDA listed —
CVS Therapeutic Menthol Gel 2 g/100g 59779-0118-08 CVS 227 g — — FDA listed —
Blue Ice Analgesic 2 g/100g 61734-0021-03 Delon 227 g — — FDA listed —
daily solutions Ice Blue Analgesic 20 mg/g 67385-0708-01 Garcoa, 227 g — — FDA listed —
Cold Ice Analgesic Gel 4.54 g/227g 68747-3021-02 Dabur 227 g — — FDA listed —
ICE MUSCLE RUB Leon M.C .02 g/g 69822-0103-08 Southern 227 g — — FDA listed —
Ice Quake Muscle Rub Blue .02 g/g 69822-0104-08 Southern 227 g — — FDA listed —
TheraCare Pain Relieving Menthol Gel 2 g/mL 71101-0015-01 Veridian 1 bottle — — FDA listed —
DCH Pain Relieving 2 g/100g 72839-0031-08 Derma 227 g — — FDA listed —
Dermachange Cold Therapy 2 g/100g 83520-0131-08 Private 227 g — — FDA listed —
Wish ultra winter ice 2 g/100g 84809-0008-01 LJ 200 g — — FDA listed —
Clean Remedies Cr Pain Relief 20 mg/g 73371-0048-03 Clean 85 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

🏛️
2011
On the market since
Nov 2011
📍
2026
Currently FDA-listed
15 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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII LRX7AJ16DT
    A blue mineral compound containing copper and sulfate. It's occasionally used as a colorant and preservative in some pharmaceutical and cosmetic preparations to maintain product stability and appearance.
  • 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 SK47B8698T
    A mineral compound containing magnesium, sulfate, and water molecules. Used in medicines as a laxative agent and sometimes as a filler or anti-caking ingredient to improve powder flow and stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 3J50XA376E
    Thymol is a natural compound derived from thyme and other plants. It acts as a preservative and flavoring agent in medicines, helping prevent microbial growth and add taste.
  • 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 statesammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

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

LabelerCrown Laboratories
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedNov 2011
Product typeHuman Otc Drug
Portfolio43 products on file

More NDCs from Crown Laboratories labeler code 00316

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor or Pharmacist 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 30 words ▾

Uses ● temporarily relieves minor aches and pains of muscles and joints associated with: ● arthritis ● simple backache ● strains ● bruises ● sprains ● provides cooling penetrating relief

⏱️ Dosage and Administration 37 words ▾

Directions clean affected area before applying product adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

⚠️ Warnings 97 words ▾

Warnings For external use only Do not use with other topical pain relievers with heating pads or heating devices When using this product do not use in or near the eyes do not apply to wounds or damaged skin do not bandage tightly Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 43 words ▾

Other information store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature], in a tightly closed container store in a cool place do not use, pour, spill or store near heat or open flame

🧪 Active Ingredient 4 words ▾

Active ingredient Menthol 2%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

🎯 Purpose 3 words ▾

Purpose Topical analgesic

📄 Do Not Use 14 words ▾

Do not use with other topical pain relievers with heating pads or heating devices

📄 Ask a Doctor or Pharmacist Before Use If 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 When Using This Product 24 words ▾

When using this product do not use in or near the eyes do not apply to wounds or damaged skin do not bandage tightly

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

📄 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 5 words ▾

Questions or comments? call 1-833-279-6522

📄 Package Label / Principal Display Panel 25 words ▾

Principal Display NDC 0316-0226-08 ORIGINAL THERAPEUTIC Mineral Ice® Menthol Pain Relieving Gel Greaseless with DEEPCOLD® Pain Reliever Net wt. 8 oz (226.8 g) P11529.00 p1152900

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 Mineral Ice Pain Relieving (this brand).

Top reported reactions

Dyspnoea87
Fatigue86
Pain81
Pruritus78
Dizziness67
Headache67
Cough66

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly91

Reporter sex

1,013 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization336
Death132
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 110 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 Crown Laboratories. 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 99.2 g (00316-0226-35), 453.6 g (00316-0226-16). 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?
Crown Laboratories 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.
← 00316-0225-15 · Crown 00316-0227-06 · Crown →
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.