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OrthoNesic Pain Relieving Gel MENTHOL, CAMPHOR 3.5 g/100g; 3 g/100g Gel, 170 g — NDC 63347-0420-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OrthoNesic Pain Relieving Gel MENTHOL, CAMPHOR 3.5 g/100g; 3 g/100g Gel, 170 g — NDC 63347-420-01 (Billing 63347-0420-01)

by Blaine Labs Inc. · 170 g in 1 TUBE

This is a package of 170 g of OrthoNesic Pain Relieving Gel MENTHOL, CAMPHOR 3.5 g/100g; 3 g/100g Gel from Blaine Labs Inc., marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 63347-0420-01
🏷️ FDA NDC (as labeled) 63347-420-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 63347-420-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63347 labeler · 420 product · 01 package
Package marketed since
Jun 12, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6334742001 7
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63347-420-01
Product NDC 63347-420
11-digit billing NDC 63347042001
RxCUI 2745970, 2745972
UNII L7T10EIP3A, 5TJD82A1ET
Application # M017
SPL Set ID 122f60c2-f8df-4625-8bb8-a2244a261b5d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-12
Route CUTANEOUS
Dosage form GEL
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Quick answers
  • RxCUI (RxNorm): 2745970
Why two NDCs? The FDA registers this code as 63347-420-01 — 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 → 63347-0420-01. 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

🧪 What is this product?

OrthoNesic Pain Relieving Gel is a topical gel applied directly to the skin, containing menthol and camphor as active ingredients. Both menthol and camphor are commonly used in over-the-counter pain relief products to produce a cooling or warming sensation on the skin. This product is marketed as an OTC monograph drug, meaning it follows established FDA rules for its category rather than undergoing individual product review. The gel form allows for direct application to localized areas where minor muscle or joint discomfort may occur.

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.
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
63347-0420-01 You're viewing this Main listing 170 g in 1 TUBE 2026-06-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
OrthoNesic Pain Relieving Gel 3.5 g/100g; 3 g/100gthis 63347-0420-01 Blaine 170 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 00UK7646FG
    Capsicum is a natural plant extract from red peppers. It's used as a colorant and flavoring agent to give medicines their red or orange appearance and mild spicy taste.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • 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 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 statesInactive Ingredients:  Aminomethylpropanol, Camellia Sinensis (Green Tea) Leaf Extract, Capsicum Annum/Frutescens Fruit Extract, Carbomer, Ethyl Alcohol, FD&C Blue #1, FD&C Yellow #5, Ilex Praguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Purified 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

LabelerBlaine Labs Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code63347
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Blaine Labs Inc. labeler code 63347

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Uses ■ For temporary relief from minor aches and pains of muscles and joints associated with arthritis, bruises, strains simple backache, and sprains.

⏱️ Dosage and Administration 53 words ▾

Directions: Apply to the affected areas not more than 3 to 4 times daily. Rinse hands with cool water. ■ Adults and children 2 years and older: A pply to affected area not more than 3 to 4 times daily. ■ Children under 2 years of age: do not use, consult a physician.

⚠️ Warnings 72 words ▾

Warnings - for extrenal use only Do not use: ■ on wounds or damaged skin ■ with a heating pad When using this product : ■ avoid contact with eyes or mucous membranes ■ do not bandage tightly Stop use and ask a physician if : ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ excessive skin irritation develops.

🧪 Active Ingredient 10 words ▾

DRUG FACTS Active Ingredients Menthol - 3.5% Camphor - 3.0%

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients: Aminomethylpropanol, Camellia Sinensis (Green Tea) Leaf Extract, Capsicum Annum/Frutescens Fruit Extract, Carbomer, Ethyl Alcohol, FD&C Blue #1, FD&C Yellow #5, Ilex Praguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Purified Water

🎯 Purpose 9 words ▾

Purpose Menthol - Topical Analgesic Camphor - Topical Analgesic

📄 Keep Out of Reach of Children 28 words ▾

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) immediately Flammable: Keep away from excessive heat or open flame

📄 Other Information 11 words ▾

Other Information Store in a cool, dry area at 15°-30° C(59°-86°F).

📄 Package Label / Principal Display Panel 38 words ▾

BLAINE LABS ORTHO-NESIC PAIN-RELIEVING-GEL - Labeling -------------------------------------------------- BLAINE LABS ORTHO-NESIC PAIN-RELIEVING-GEL Menthol and Camphor

4.0OZ (170 g) MANUFACTURED BY: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90870 BLAINE LABS RES 420 6 OZ OrthoNesic

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, CAMPHOR — the ingredient across all brands.

Top reported reactions

Application Site Burn2
Application Site Vesicles2
Blister2
Chemical Injury2
Drug Reaction With Eosinophilia And Systemic Symptoms2
Tubulointerstitial Nephritis2
Application Site Infection1

Age at onset

Adult1
Elderly3

Reporter sex

20 reports

Serious outcomes

Hospitalization5
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 5 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 Blaine Labs Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Blaine Labs 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.
← 63347-0380-01 · Blaine 63347-0470-01 · Blaine →
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.