Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM 20 mg/g Gel, 226.8 g — NDC 0536-1061-39 (Billing 00536-1061-39)
by Rugby Laboratories · 226.8 g in 1 JAR
This is a package of 226.8 g of Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM 20 mg/g Gel from Rugby Laboratories, marketed since Jan 2015 and currently FDA-listed; retail pharmacies pay about $0.0101 per g (NADAC). It is this product's only package size.
NDC 00536-1061-39
🏷️ FDA NDC (as labeled)
0536-1061-39
billing pads the labeler segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0536-1061-39 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0536 labeler · 1061 product · 39 package
- Package marketed since
- Jan 20, 2015
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 227 g per package
- Barcode (UPC-A, from the NDC)
- 3 0536106139 5
- Medicaid fills, this package
- 41 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0536-1061-39
Product NDC
0536-1061
11-digit billing NDC
00536106139
NCPDP billing unit
GM — per gram (weight)
RxCUI
311502
UNII
L7T10EIP3A
Application #
M017
SPL Set ID
2b65cb6a-4364-4770-b7b9-5c4637edd01a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2015-01-20
Route
TOPICAL
Dosage form
GEL
Substance
MENTHOL, UNSPECIFIED FORM
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90070060004010
GPI class
Blue Gel
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
BLUE 2% GEL
FDB brand name
Blue Gel
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 0536-1061-39 — 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 → 00536-1061-39. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name BLUE 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.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about MENTHOL, UNSPECIFIED FORM?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.010 | $2.29 / 226.8 g |
| Medicaid paysCMS SDUD · 12 mo | $0.0360 | $8.16 / 226.8 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▼ Down 8% over the last 16 months.
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.
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00536-1061-39 You're viewing this Main listing | 226.8 g in 1 JAR | 2015-01-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Ice Blue External Analgesic 20 mg/gthis 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/g 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 | — |
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
🏛️
2015
On the market since
Jan 2015
📍
2026
Currently FDA-listed
11 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
blue
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.
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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 K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
-
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 ML30MJ2U7I
A mineral salt form of magnesium and sulfate. It serves as a filler to add bulk to the tablet or capsule and may help the medicine dissolve or disintegrate properly in the body.
-
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, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerRugby Laboratories
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedJan 2015
Product typeHuman Otc Drug
Portfolio149 products on file
More NDCs from Rugby Laboratories labeler code 00536
- rugby Peg 3350 Polyethylene Glycol 3350 17 g/17g Powder, For Solution NDC 0536-1052-24
- Aspirin 325 mg Tablet, Film Coated NDC 0536-1054-05
- Rugby Benzoyl Peroxide Acne Medication 50 mg/mL Gel NDC 0536-1055-25
- Rugby Benzoyl Peroxide Acne Medication 100 mg/mL Gel NDC 0536-1056-25
- Rugby Benzoyl Peroxide Acne Medication 50 mg/mL Lotion NDC 0536-1057-75
- Rugby Benzoyl Peroxide Acne Medication 100 mg/mL Lotion NDC 0536-1058-75
- Rugby All Day Relief Naproxen Sodium 220 mg Tablet, Film Coated NDC 0536-1093-01
- rugby all day relief Naproxen Sodium 220 mg Tablet, Film Coated NDC 0536-1094-01
- Rugby Pain Relieving Analgesic Menthol, Unspecified Form and Methyl Salicylate 10 mg/g; 150 mg/g Cream NDC 0536-1101-45
- Alcohol Prep Pad ISOPROPYL .7 mL/mL Swab NDC 0536-1103-01
- Nicotine transdermal system step 3 7 mg/24h Patch, Extended Release NDC 0536-1106-52
- Nicotine transdermal system step 2 14 mg/24h Patch, Extended Release NDC 0536-1107-52
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
⏱️ Dosage and Administration ▾
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: do not use, consult a doctor.
⚠️ Warnings ▾
Warnings For external use only Do not use with other topical pain relievers. with heating pads or other 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, or if symptoms persist for more than 7 days or clear up and occur again within a few days. redness or irritation develops.
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 immediately.
📦 Storage and Handling ▾
Other information store at room temperature 20 to 25°C (68 to 77°F) Keep lid tightly closed. Do not use, pour, spill or store near heat or open flame.
🧪 Active Ingredient ▾
Active ingredient Menthol 2.0%
🧪 Inactive Ingredients ▾
Inactive ingredients ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water
🎯 Purpose ▾
Purpose Pain relieving gel
📄 Do Not Use ▾
Do not use with other topical pain relievers. with heating pads or other heating devices.
📄 When Using This Product ▾
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 ▾
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. redness or irritation develops.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
📄 Questions or Comments ▾
Questions or comments? 1-800-645-2158
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label Rugby ® NDC 0536-1061-39 Blue Gel External Analgesic Pain Relieving Gel for Minor Aches and Pains of Muscles and Joints COMPARE TO ACTIVE INGREDIENT IN MINERAL ICE®* NET WT 8 OZ (226.8 g) PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
41
Units reimbursed last 4 qtrs
9.3K
Gross reimbursed last 4 qtrs
$335.01
Avg / prescription
$8.17
Avg / unit
$0.0360
Latest quarter Q1 2026
16Rx
Medicaid pays / g
$0.0360
gross reimbursed
vs
NADAC / g
$0.0101
acquisition cost
=
Spread
+$0.0259
+256% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 41 Rx
State Medicaid map
Units reimbursed · per 100k residents
20.8149
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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, UNSPECIFIED FORM — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 26%
Female · 73%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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.