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NeuroSoothe Camphor, Menthol 3 g/85g; 3 g/85g Liquid, 85 g — NDC 85622-0510-85 package photo

NeuroSoothe Camphor, Menthol 3 g/85g; 3 g/85g Liquid, 85 g

by Blue Heron Pharmaceuticals, LLC · 85 g in 1 BOTTLE, WITH APPLICATOR (85622-510-85)
NDC 85622-0510-85
🏷️ FDA NDC (as labeled) 85622-510-85 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 85622-510-85
Product NDC 85622-510
11-digit billing NDC 85622051085
NCPDP billing unit GM — per gram (weight)
RxCUI 630714
UNII 5TJD82A1ET, L7T10EIP3A
SPL Set ID e3c21cdb-0027-486b-9b83-c1261c3e73a6
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-23
Route TOPICAL
Dosage form LIQUID
Substance CAMPHOR (SYNTHETIC); MENTHOL
GCN Seq No 088737
GCN 58888
HICL code 002600
Ingredient (HICL) Menthol/Camphor
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 NEUROSOOTHE 3%-3% GEL ROLL-ON
FDB brand name Neurosoothe Warm Therapy
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 85622-510-85 — 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 → 85622-0510-85. 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.

🏭 Manufacturer & labeler

LabelerBlue Heron Pharmaceuticals, LLC
Labeler code85622
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio9 products on file
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.

🩺 Clinical

Label name NEUROSOOTHE 3%-3% GEL ROLL-ON Ingredient Menthol/Camphor
🧪 What is this product?

NeuroSoothe is a topical liquid containing camphor and menthol as active ingredients. This product is marketed without an approved FDA application. Camphor and menthol are commonly used in topical products for their cooling and warming sensations on the skin. These ingredients are typically found in over-the-counter preparations intended to provide temporary relief of minor discomfort.

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.

🧪 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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII 8U3877WD44
    A fragrant oil extracted from grapefruit peel used as a flavoring and aromatic agent to improve the taste and smell of the medicine.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII 06L18L32G6
    A plant extract from meadowsweet flowers. It's used as a natural flavoring, fragrance, or traditional botanical ingredient in formulations.
  • 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 T07U1161SV
    A plant extract from witch hazel leaves, used in medicines as a natural astringent and skin-soothing agent. It helps reduce irritation and is often included in topical formulations for its mild anti-inflammatory properties.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII JWB78P295A
    A plant extract from damask rose flowers used as a natural fragrance, flavoring agent, or coloring component in medicines. It adds pleasant aroma or taste to the product.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • 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.
  • UNII N59C6T6D72
    Yucca schidigera stem is a plant-derived natural ingredient used as a foaming agent and flavor enhancer in medications. It helps create a smoother texture and can improve taste in oral formulations.

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

The official label also statesAloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Filipendula Ulmaria (Queen of the Prairie) Flower Extract, Glycerin, Hamamelis Virginiana (WitchHazel) Leaf Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate, Yucca Schidigera Stem Extract.

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.

💲 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 mLPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sore No More .03 g/g; .03 g/g 61577-2280-02 SOMBRA 58.7 g — — FDA listed —
Muscle Ease .03 g/g; .03 g/g 61577-2301-02 SOMBRA 56.7 g — — FDA listed —
Sore No More Warm Therapy .03 g/g; .03 g/g 61577-3234-02 SOMBRA 907.2 g — — Discontinued —
Pain No More Therapy .03 g/g; .03 g/g 61577-7365-01 SOMBRA 5 g — — FDA listed —
NeuroSoothe 3 g/85g; 3 g/85gthis 85622-0510-85 Blue 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

🏛️
2026
On the market since
Feb 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.

🔬 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 NeuroSoothe (this brand).

Top reported reactions

Peripheral Motor Neuropathy2
Agitation1
Drug Abuse1
Dry Mouth1
Dyspnoea1
International Normalised Ratio Increased1
Multiple Organ Dysfunction Syndrome1

Age at onset

Adult1

Reporter sex

0 reports

Serious outcomes

Hospitalization4
Death1
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85622-0510-85 You're viewing this 85 g in 1 BOTTLE, WITH APPLICATOR (85622-510-85) 2026-02-23 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 FDA registers it as 85622-510-85, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85622-0510-85, written without dashes as 85622051085. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85622-0510-85, the first segment (85622) is the labeler code FDA assigned to Blue Heron Pharmaceuticals, LLC; the middle segment (0510) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (85) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Blue Heron Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Blue Heron Pharmaceuticals, LLC 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.

📄 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
🎯 Indications and Usage 13 words ▾

Uses: Temporary relief of minor aches and pains associated with: Simple backache Arthritis

⏱️ Dosage and Administration 38 words ▾

Directions: Adults and children 2 years of age and older: Apply to affected area not more then 3 to 4 times daily. Rub thoroughly until gel is absorbed. For children under 2 years of age: Ask a doctor.

⚠️ Warnings 46 words ▾

Warnings: For external use ONLY. Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, aks a healthcare professional before use. When using this product: Avoid bandaging tightly Avoid contact with eyes Keep out of the reach of children

📦 Storage and Handling 16 words ▾

Storage: Store at 68-77℉ (20-25℃) - Room Temperature Do not exceed 100 oF (38 o C)

🧪 Active Ingredient 7 words ▾

Active Ingredients: Camphor 3% & Menthol 3%

🧪 Inactive Ingredients 59 words ▾

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Filipendula Ulmaria (Queen of the Prairie) Flower Extract, Glycerin, Hamamelis Virginiana (WitchHazel) Leaf Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate, Yucca Schidigera Stem Extract.

🎯 Purpose 3 words ▾

Purposes: Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85622-0501-15 · Blue 85622-0511-85 · Blue →
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.