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POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE 10 mg/mL Solution, 15 mL — NDC 81923-0366-00 package photo

POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE 10 mg/mL Solution, 15 mL

by SKINS SEXUAL HEALTH LIMITED · 15 mL in 1 BOTTLE, SPRAY (81923-366-00)
NDC 81923-0366-00
🏷️ FDA NDC (as labeled) 81923-366-00 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

⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Class II · Jun 8, 2026 — Lack of Assurance of Sterility (Asclemed USA Inc.) · FDA recall D-0658-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0529-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0532-2026
Class II · Nov 30, 2021 — Superpotent Drug: Minimally superpotent (Teligent Pharma, Inc.) · FDA recall D-0296-2022
Class I · Nov 30, 2021 — Superpotent Drug (Teligent Pharma, Inc.) · FDA recall D-0295-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81923-366-00
Product NDC 81923-366
11-digit billing NDC 81923036600
UNII V13007Z41A
UPC 0847878002527
Application # M017
SPL Set ID 42e0c40f-1efd-45ef-815d-53d193d720eb
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 2022-10-03
Route TOPICAL
Dosage form SOLUTION
Substance LIDOCAINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 81923-366-00 — 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 → 81923-0366-00. 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

LabelerSKINS SEXUAL HEALTH LIMITED
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code81923
First marketedOct 2022
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

📗 Our plain-language guide HelloPharmacist
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied 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.

🧪 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • 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 935E97BOY8
    Folic acid is a synthetic form of a B vitamin. In medicines, it's added as a nutritional supplement or to help prevent vitamin deficiency, especially in prenatal formulas.
  • 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII XK4IUX8MNB
    Hypericum perforatum, also known as St. John's Wort, is a plant extract used in some medicines. It may serve as an active botanical ingredient or flavoring agent depending on the formulation.
  • UNII HP7119212T
    A plant extract from maca root used as a natural ingredient or filler in supplements. It may help bind ingredients together or add bulk to the formulation.
  • UNII 0G389FZZ9M
    Levocarnitine is an amino acid derivative that helps transport fatty acids in cells. In medications, it serves as an active nutritional component rather than a typical inactive binder or filler.
  • UNII 2679MF687A
    Niacin is a B vitamin used in medications as a nutritional supplement and pH buffer. It helps stabilize the product and may support formulation integrity during manufacturing and storage.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII J7WWH9M8QS
    A plant-derived powder made from saw palmetto berries. It's included in some formulations as a natural ingredient and potential filler, though its primary role is typically as an active botanical rather than a structural excipient.
  • UNII 4X4HLN92OT
    A plant extract from tribulus terrestris, used as a filler and binder to add bulk to the tablet or capsule, helping hold the medicine together and reach the proper size.
  • 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.

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

The official label also statesAloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), l-Arginine, Ascorbic Acid (Vitamin C), Chamomilla Recutita (Chamomile) Extract, Epimedium (Horny Goat) Weed Extract, Ethylhexylglycerin, Folic Acid (Vitamin B9), Ginko Biloba Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethylcellulose, Hypericum Perforatum (St John’s) Extract, Lepidium Meyenii (Maca) Root Extract, Niacin, Panax Ginseng Root Extract, Phenoxyethanol, Polysorbate 20, Serenoa Serrulata (Saw Palmetto) Extract, l-Carnitine, Tocopheryl Acetate (Vitamin E), Tribulus Terrestris Extract, Zemea (Corn) Propanediol.

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
NATURES CRAFT LIDOCAINE Male Genital Desensitizer 10 mg/mL 73382-0185-01 Natures 1 bottle — — FDA listed —
INTIMALE Maximum Strength Delay 10 mg/mL 81923-0197-00 SKINS 1 cylinder — — FDA listed —
POWERECT Max Power Male Delay 10 mg/mL 81923-0198-00 SKINS 1 cylinder — — FDA listed —
SKINS DELAY Maximum Strength Lidocaine 10 mg/mL 81923-0199-00 SKINS 1 cylinder — — FDA listed —
SKINS DELAY Climax Control Lidocaine 10 mg/mL 81923-0364-00 SKINS 15 ml — — FDA listed —
POWERECT Lidocaine Male Delay 10 mg/mLthis 81923-0366-00 SKINS 15 ml — — FDA listed —
Intimale Lidocaine Delay 10 mg/mL 81923-0368-00 SKINS 15 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

🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 POWERECT Lidocaine Male Delay (this brand).

Top reported reactions

Infusion Site Pain729
Nausea491
Infusion Site Erythema456
Headache438
Dyspnoea426
Diarrhoea423
Fatigue369

Age at onset

Neonate25
Infant21
Child27
Adolescent24
Adult741
Elderly388

Reporter sex

6,521 reports
Male · 35%
Female · 64%
Unknown · 1%

Serious outcomes

Hospitalization2,361
Life-threatening735
Death561
Disabling131
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 948 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81923-0366-00 You're viewing this 15 mL in 1 BOTTLE, SPRAY (81923-366-00) 2022-10-03 Active

🧭 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 FDA registers it as 81923-366-00, 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: 81923-0366-00, written without dashes as 81923036600. 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 81923-0366-00, the first segment (81923) is the labeler code FDA assigned to SKINS SEXUAL HEALTH LIMITED; the middle segment (0366) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 SKINS SEXUAL HEALTH LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SKINS SEXUAL HEALTH LIMITED 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 7 words ▾

USES: Helps to temporarily prevent premature ejaculation.

⏱️ Dosage and Administration 45 words ▾

DIRECTIONS: Apply 3 or more sprays to the head and shaft of the penis before sexual activity, or as directed by your doctor. Massage the product onto the penis until fully absorbed You should always use the minimum effective quantity. DO NOT exceed 10 sprays.

⚠️ Warnings 100 words ▾

WARNINGS: Premature ejaculation may be due to a condition requiring medical supervision. If this product, when used as directed, does not provide relief, • If you or your partner develop a rash or irritation, such as burning or itching, discontinue use and consult a physician. discontinue use and consult a physician. FOR EXTERNAL USE ONLY.

Avoid contact with eyes. Keep out of reach of children. • If product is swallowed, get medical attention or contact poison control center immediately. Do not use • on broken or inflamed skin, if partner is pregnant, on large areas of the body, or orally.

🧪 Active Ingredient 11 words ▾

ACTIVE INGREDIENT (per spray): Lidocaine HCL 10mg Purpose: Male genital desensitizer

🧪 Inactive Ingredients 74 words ▾

INACTIVE INGREDIENTS: Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), l-Arginine, Ascorbic Acid (Vitamin C), Chamomilla Recutita (Chamomile) Extract, Epimedium (Horny Goat) Weed Extract, Ethylhexylglycerin, Folic Acid (Vitamin B9), Ginko Biloba Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethylcellulose, Hypericum Perforatum (St John’s) Extract, Lepidium Meyenii (Maca) Root Extract, Niacin, Panax Ginseng Root Extract, Phenoxyethanol, Polysorbate 20, Serenoa Serrulata (Saw Palmetto) Extract, l-Carnitine, Tocopheryl Acetate (Vitamin E), Tribulus Terrestris Extract, Zemea (Corn) Propanediol.

🎯 Purpose 4 words ▾

Purpose: Male genital desensitizer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81923-0365-00 · SKINS 81923-0367-00 · SKINS →
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.