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INTIMALE Benzocaine Delay Gel 50 mg/mL Gel, 15 mL — NDC 81923-0369-00 package photo

INTIMALE Benzocaine Delay Gel 50 mg/mL Gel, 15 mL

by SKINS SEXUAL HEALTH LIMITED · 15 mL in 1 BOTTLE (81923-369-00)
NDC 81923-0369-00
🏷️ FDA NDC (as labeled) 81923-369-00 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 Benzocaine (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 · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81923-369-00
Product NDC 81923-369
11-digit billing NDC 81923036900
UNII U3RSY48JW5
UPC 0847878002701
Application # M017
SPL Set ID b845bfd5-ab73-495f-97ef-e959bc6311d9
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
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 GEL
Substance BENZOCAINE
Why two NDCs? The FDA registers this code as 81923-369-00 — 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 → 81923-0369-00. 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

🧪 What is this product?

Intimale Benzocaine Delay Gel is a topical gel containing benzocaine 50 mg/mL. Benzocaine is a local anesthetic that works by numbing the skin and surface tissues where it is applied. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established guidelines for this category of topical anesthetic products.

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzocaine — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzocaine (3 interactions) — ranked by severity →
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 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 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 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 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 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.

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

The official label also statesAqua (deionized Water), Ethylhexylglycerin, Hydroxyethylcellulose, l-Arginine, Lepidium Meyenii (Maca) Extract, Panax Ginseng Root Extract, PEG-8, Phenoxyethanol, Propylene Glycol.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
HIGHER CONTROL Male Climax Control Lubricating 50 mg/mL 70742-0180-02 Product 60 ml — — FDA listed —
BODY ACTION PRODUCTS Climax Control Gel 50 mg/mL 70742-0282-00 PRODUCT 60 ml — — FDA listed —
BODY ACTION PRODUCTS Endless Love for Men 50 mg/mL 70742-0284-00 PRODUCT 50 ml — — FDA listed —
BODY ACTION PRODUCTS Butt Eze Benzocaine 50 mg/mL 70742-0286-00 PRODUCT 60 ml — — FDA listed —
BODY ACTION PRODUCTS Prolong Lubricating 50 mg/mL 70742-0288-00 PRODUCT 60 ml — — FDA listed —
BODY ACTION PRODUCTS Higher Control Male Climax 50 mg/mL 70742-0292-00 PRODUCT 60 ml — — FDA listed —
Endless Love For Men 50 mg/mL 70742-0360-50 Body 50 ml — — FDA listed —
INTIMALE Benzocaine Delay Gel 50 mg/mLthis 81923-0369-00 SKINS 15 ml — — FDA listed —
SKINS DELAY Climax Control Benzocaine Gel 50 mg/mL 81923-0365-00 SKINS 3 ml — — FDA listed —
Chigg Away 50 mg/mL 45591-0002-04 Pierson 118 ml — — FDA listed —
BODY ACTION PRODUCTS Anal Glide Extra 50 mg/mL 70742-0287-00 PRODUCT 60 ml — — FDA listed —
Chigg Away 50 mg/mL 82645-0918-94 Pharma 118 ml — — FDA listed —
POWERECT Benzocaine Male Delay Gel 50 mg/mL 81923-0367-00 SKINS 3 ml — — FDA listed —
Chigg Away 50 mg/mL 82895-0857-05 Westlake 118 ml — — Discontinued —
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
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81923-0369-00 You're viewing this 15 mL in 1 BOTTLE (81923-369-00) 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 81923-369-00, 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: 81923-0369-00, written without dashes as 81923036900. 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 81923-0369-00, the first segment (81923) is the labeler code FDA assigned to SKINS SEXUAL HEALTH LIMITED; the middle segment (0369) 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 39 words ▾

DIRECTIONS: Apply 3-5 pumps 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 absorbedOther Information:. You should always use the minimum effective quantity.

⚠️ Warnings 79 words ▾

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

🧪 Active Ingredient 8 words ▾

ACTIVE INGREDIENT: Benzocaine 5.00% Purpose: Male Genital Desensitizer

🧪 Inactive Ingredients 20 words ▾

INACTIVE INGREDIENTS: Aqua (deionized Water), Ethylhexylglycerin, Hydroxyethylcellulose, l-Arginine, Lepidium Meyenii (Maca) Extract, Panax Ginseng Root Extract, PEG-8, Phenoxyethanol, Propylene Glycol.

🎯 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 ↗
← 81923-0368-00 · SKINS 81927-0105-01 · Shorla →
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.