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LUBRICAINE 5 LIDOCAINE 5% 5 g/100g Gel, 113 g — NDC 63135-0924-04 package photo

LUBRICAINE 5 LIDOCAINE 5% 5 g/100g Gel, 113 g

by ESBA LABORATORIES INC. · 113 g in 1 TUBE (63135-924-04)
NDC 63135-0924-04
🏷️ FDA NDC (as labeled) 63135-924-04 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) 63135-924-04
Product NDC 63135-924
11-digit billing NDC 63135092404
NCPDP billing unit GM — per gram (weight)
UNII 98PI200987
Application # M015
SPL Set ID 9d98afbf-11ce-745b-e053-2a95a90abc14
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 2019-03-20
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE
GPI-14 89200025004020
GPI class Lubricaine
Why two NDCs? The FDA registers this code as 63135-924-04 — 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 → 63135-0924-04. 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

LabelerESBA LABORATORIES INC.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code63135
First marketedMar 2019
Product typeHuman Otc Drug
Portfolio5 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.

  • 0.3 g / 100 g 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.
  • 0.72 g / 100 g UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 0.1 g / 100 g UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • 0.08 g / 100 g UNII 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • 25 g / 100 g 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.
  • 2.5 g / 100 g UNII 3B8D35Y7S4
    A weak organic acid made from natural or synthetic sources. It works as a pH buffer and preservative to maintain the medicine's stability and prevent bacterial growth during storage.
  • 38.3 g / 100 g UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 1 g / 100 g UNII 6TC6NN0876
    A natural sweetener extracted from stevia plant leaves. It sweetens the medicine to improve taste without adding calories, helping make medications easier to take.
  • 2 g / 100 g UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAllantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.

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
RectaSmoothe 5 g/100g 69315-0301-30 Leading 1 tube $0.458 — Discontinued —
Rite Aid Rectal Care 5 g/100g 11822-0265-01 Rite 1 tube — — FDA listed —
Topicaine 5 5 g/100g 63135-0581-04 ESBA 113 g — — FDA listed —
Curist Lidocaine Relief 5 g/100g 72559-0024-32 Little 57 g — — FDA listed —
Lubricaine 5 5 g/100gthis 63135-0924-04 ESBA 113 g — — FDA listed —
Formula 2 Skin Care 5 g/100g 72839-0265-00 Derma 28 g — — FDA listed —
Lipocaine 5 5 g/100g 63135-0811-04 ESBA 113 g — — FDA listed —
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum 5 g/100g 73287-0040-01 Telebrands 1 jar — — FDA listed —
Anecream 5 5 g/100g 24357-0702-15 Focus 1 tube — — FDA listed —
Doctor Butlers Hemorrhoid and Fissure External Pain Formula 5 g/100g 70942-0121-01 Beyond 28 g — — FDA listed —
Lidocaine anorectal cream 5 g/100g 85833-0001-04 EveryMarket 1 jar — — FDA listed —
Rectal Care Cream Revivol 5 g/100g 72839-0141-01 Derma 28 g — — FDA listed —
Moshe Numbing Hemorrhoidal 5 g/100g 72839-0218-01 Derma 42.5 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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
63135-0924-04 You're viewing this 113 g in 1 TUBE (63135-924-04) 2019-03-20 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 63135-924-04, 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: 63135-0924-04, written without dashes as 63135092404. 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 63135-0924-04, the first segment (63135) is the labeler code FDA assigned to ESBA LABORATORIES INC.; the middle segment (0924) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 ESBA LABORATORIES INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ESBA LABORATORIES 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.

📄 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 13 words ▾

Uses For temporary relief of pain, soreness or burning in the perianal area

⏱️ Dosage and Administration 35 words ▾

Directions Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application. Apply externally to the affected area up to 6 times daily.

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 4 words ▾

Active Ingredient Lidocaine 5%

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.

🎯 Purpose 3 words ▾

Purpose Anorectal Anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63135-0811-04 · ESBA 63138-0120-01 · Parkmor →
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.