Home › NDC Lookup › Ingredients › Lidocaine - 4% › 85622-0521-15
Lidocaine 4% Patch 40 mg/g Patch, 15 pouches — NDC 85622-0521-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocaine 4% Patch 40 mg/g Patch, 15 pouches — NDC 85622-521-15 (Billing 85622-0521-15)

by Blue Heron Pharmaceuticals LLC · 15 POUCH in 1 BOX / 1 g in 1 POUCH

This is a package of 15 pouches of Lidocaine 4% Patch 40 mg/g Patch from Blue Heron Pharmaceuticals LLC, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 85622-0521-15
🏷️ FDA NDC (as labeled) 85622-521-15 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85622-521-15
Product NDC 85622-521
11-digit billing NDC 85622052115
RxCUI 1737778
UNII 98PI200987
Application # 505G(a)(3)
SPL Set ID f41dc11d-0be1-439f-b4c7-52ad02288dd4
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-11
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1737778
Why two NDCs? The FDA registers this code as 85622-521-15 — 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 → 85622-0521-15. 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.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Prescription lidocaine transdermal (Dermalid®, Lidoderm®, Ztildo®) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr®, Aspercreme®, Lidocare®, Salonpas®, others) is also available to relieve minor pain in shoulders, arms, back, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine 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 eachPer 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
85622-0521-15 You're viewing this Main listing 15 POUCH in 1 BOX / 1 g in 1 POUCH 2026-08-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine 4% Patch 40 mg/g 70512-0014-30 SOLA 6 pouches $1.100 — Availability likely —
Lidocaine 4% Patch 40 mg/g 85477-0302-10 Oncora 10 pouches $1.100 — Availability likely —
Lidocaine Pain Relieving Patch 40 mg/g 68001-0625-93 BluePoint 5 patches $1.100 — Availability likely —
Lidocaine 4% Patch 40 mg/g 70512-0812-30 SOLA 30 pouches $1.100 — Availability likely —
Relevea Pain Relief Patch 40 mg/g 51028-0004-01 Links 15 patches — — FDA listed —
LABOFLEX Lidocaine Pain Relieving Patch 40 mg/g 83655-0109-15 Laboflex, 5 pouches — — FDA listed —
Lidocaine 4% Patch 40 mg/gthis 85622-0521-15 Blue 15 pouches — — FDA listed —
Lidocaine 4% Patch 40 mg/g 85622-0522-30 Blue 30 pouches — — 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
Aug 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.

What it looks like

ShapeRectangle
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.

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

  • UNII J94PBK7X8S
    A synthetic polymer derived from acrylic acid monomers. In medicines, it's used as a binder to hold tablet ingredients together and sometimes as a coating agent to control where and how the drug releases in the body.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesAcrylic Adhesive, Polyethylene Fabric

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

LabelerBlue Heron Pharmaceuticals LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code85622
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio4 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.

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 7 words ▾

Uses For the temporary relief of pain

⏱️ Dosage and Administration 72 words ▾

Directions Adult and children 12 years of age and over: Clean and dry affected area Peel patch off plastic liner and place patch on affected area for no more than 12 hours Wash hands after applying patch Under age 12, consult a physician before use For easier removal of the patch, apply rubbing alcohol or baby oil to adhesive edge while gently peeling Children under 12 years of age: Consult a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 17 words ▾

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

🧪 Active Ingredient 4 words ▾

Active Ingredients Lidocaine 4%

🧪 Inactive Ingredients 6 words ▾

Inactive Ingredients Acrylic Adhesive, Polyethylene Fabric

🎯 Purpose 3 words ▾

Purposes Topical analgesic

📄 Do Not Use 29 words ▾

Do Not Use If you are allergic to Lidocaine On open wounds or on damaged, broken or irritated skin Remove immediately if you sense a burning sensation after application

📄 Ask a Doctor or Pharmacist Before Use If 9 words ▾

If pregnant or breast-feeding, Ask a physician before use.

📄 When Using This Product 54 words ▾

When using this product: Do not use other topical products. Do not allow contact with eyes or mucous membranes Keep away from excessive heat. Do not apply heating pad to area of use. Apply only to clean, dry, untreated skin. Use only as directed. Read and follow all directions and warnings on this label.

📄 Stop Use and Ask a Doctor If 16 words ▾

Stop use and ask a doctor if: Condition worsens Symptoms persist for more than 7 days

📄 Keep Out of Reach of Children 30 words ▾

Keep out of reach of children If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

📄 Questions or Comments 3 words ▾

Questions? Call: 813-380-0271

📄 Package Label / Principal Display Panel 2 words ▾

Label Label

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 Lidocaine 4% Patch (this brand).

Top reported reactions

Pain3,193
Nausea3,065
Fatigue3,054
Headache2,826
Dyspnoea2,175
Pneumonia2,006
Diarrhoea1,975

Reporter sex

49,106 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,671
Death4,997
Disabling1,211
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 4,118 2,260
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 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.
← 85622-0511-85 · Blue 85622-0522-30 · 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.