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GOLD LABEL B NUMB LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE 5 g/100mL; .01 g/100mL Spray, 59 mL — NDC 82617-0104-59 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GOLD LABEL B NUMB LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE 5 g/100mL; .01 g/100mL Spray, 59 mL — NDC 82617-104-59 (Billing 82617-0104-59)

by SCALP TECH INC · 59 mL in 1 BOTTLE, SPRAY

This is a package of 59 mL of GOLD LABEL B NUMB LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE 5 g/100mL; .01 g/100mL Spray from SCALP TECH INC, marketed since Feb 2023 and currently FDA-listed. It is this product's only package size.

NDC 82617-0104-59
🏷️ FDA NDC (as labeled) 82617-104-59 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 Oct 1, 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 82617-104-59 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82617 labeler · 104 product · 59 package
Package marketed since
Feb 22, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8261710459 4
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82617-104-59
Product NDC 82617-104
11-digit billing NDC 82617010459
RxCUI 2601579
UNII V13007Z41A, WBB047OO38
Application # M015
SPL Set ID 1211590a-13b5-2e75-e063-6394a90a0f86
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist [EPC
Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Agonists
Physiologic effect Local Anesthesia
Chemical class Amides; Catecholamines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-23
Route TOPICAL
Dosage form SPRAY
Substance LIDOCAINE HYDROCHLORIDE; EPINEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2601579
Why two NDCs? The FDA registers this code as 82617-104-59 — 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 → 82617-0104-59. 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 alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Catecholamine
Drug family (ATC) Other agents for local oral treatment, Local hemostatics, Adrenergic and dopaminergic agents
How it works Adrenergic alpha-Agonists, Adrenergic beta-Agonists
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

📗 Our plain-language guide HelloPharmacist
  • This combination is used in two main ways. When given as an injection by a healthcare provider, it numbs a specific part of your body — for example, during surgery, a dental proced...
  • Some lightheadedness, drowsiness, or tingling around the mouth can happen if a little more drug than expected gets into your bloodstream — those are early warning signs your care t...
  • Will I feel any side effects from the injection?
  • Make sure your provider knows about all your medications — especially antidepressants called MAO inhibitors or tricyclics, any beta-blocker blood pressure medications, and anything...
📖 Read our full Epinephrine / 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82617-0104-59 You're viewing this Main listing 59 mL in 1 BOTTLE, SPRAY 2024-02-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
The Solution 5 g/100mL; .01 g/100mL 82617-0101-14 SCALP 118 ml — — FDA listed —
Gold Label B Numb 5 g/100mL; .01 g/100mLthis 82617-0104-59 SCALP 59 ml — — 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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 Epinephrine / Lidocaine 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 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.

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

The official label also statesAQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

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

LabelerSCALP TECH INC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code82617
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from SCALP TECH INC labeler code 82617

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

USES TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES: ITCHING PAIN SORENESS BURNING

⏱️ Dosage and Administration 66 words ▾

DIRECTIONS ADULTS AND CHILDREN 12 YEARS AND OVER CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER RINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PAD GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCT USE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY DO NOT USE MORE OFTEN THAN DIRECTED

⚠️ Warnings 109 words ▾

WARNINGS FOR EXTERNAL USE ONLY. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE HEART DISEASE HIGH BLOOD PLESSURE THYROID DISEASE DIABETES DIFFICULTY IN URINATION TAKE MEDICINE FOR HIGH BLOOD PRESSURE DEPRESSION WHEN USING THIS PRODUCT DO NOT PUT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR. STOP USE AND ASK A DOCTOR IF BLEEDING OCCURS CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS OCCUR YOU EXPERIENCE WEAKNESS CONFUSION HEADACHE DIFFICULTY BREATHING PALE, GREY OR BLUE COLOURED SKIN.

THESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE.

📦 Storage and Handling 9 words ▾

OTHER INFORMATION STORE AT ROOM TEMPERATURE (15° - 30°C)

🧪 Active Ingredient 11 words ▾

ACTIVE INGREDIENT LIDOCAINE HCL 5% EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%

🧪 Inactive Ingredients 7 words ▾

INACTIVE INGREDIENTS AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

🎯 Purpose 3 words ▾

PURPOSE LOCAL ANESTHETIC

📄 Keep Out of Reach of Children 19 words ▾

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, CALL A POISON CONTROL CENTER OR GET MEDICAL HELP RIGHT AWAY.

📄 Questions or Comments 4 words ▾

QUESTIONS? 1 (800) 611-7720

📄 Package Label / Principal Display Panel 1 words ▾

GOLD

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 SCALP TECH INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SCALP TECH 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.
← 82617-0103-59 · SCALP 82617-0105-60 · SCALP →
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.