TOPICAINE LIDOCAINE 4% 4 g/100g Gel, 113 g
by ESBA LABORATORIES INC. · 113 g in 1 TUBE (63135-312-04)
NDC 63135-0312-04
🏷️ FDA NDC (as labeled)
63135-312-04
billing pads the product segment with a zero
This package
Contains113 g
Pack sizes3 compare ↓
OTC
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2015. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
63135-312-04
Product NDC
63135-312
11-digit billing NDC
63135031204
NCPDP billing unit
GM — per gram (weight)
UNII
98PI200987
UPC
0363135312135
Application #
M017
SPL Set ID
7f96e980-891e-743d-e053-2a91aa0aea5f
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
Discontinued
FDA listing status
Discontinued by firm (certified through Jun 2015)
Marketing start
2003-04-20
Route
TOPICAL
Dosage form
GEL
Substance
LIDOCAINE
GPI-14
90850060004015
GPI class
Topicaine
GCN Seq No
068687
GCN
31517
HICL code
010705
Ingredient (HICL)
Lidocaine
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5H
Therapeutic class — specific (HIC3)
Topical Local Anesthetics
AHFS code
72:00.00.00
AHFS class
Local Anesthetics
FDB label name
TOPICAINE 4% GEL
FDB brand name
Topicaine
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 63135-312-04 — 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 → 63135-0312-04. 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.
🏷️ 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.
🏭 Manufacturer & labeler
LabelerESBA LABORATORIES INC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code63135
First marketedApr 2003
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
Label name TOPICAINE 4% GEL Ingredient Lidocaine
📗 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about LIDOCAINE 4%?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 system | Per g | Per 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Lidocaine 4 g/100g 00536-1357-95 | Rugby | 1 tube | $0.428 | — | Availability likely | — |
| Lidocaine 4% Topical Anesthetic Cream 4 g/100g 83720-0523-01 | Oncor | 1 tube | $0.490 | — | Availability likely | — |
| Zcaine Fast Acting Anesthetic 4 g/100g 27789-0911-02 | PHI, | 60 g | — | — | FDA listed | — |
| Plum Smooth Plumb Numb Gelee 4 g/100g 49911-0884-01 | Universal | 28.35 g | — | — | FDA listed | — |
| Hush Anesthetic 40 mg/g 49947-0002-02 | HUSH | 56.7 g | — | — | FDA listed | — |
| Sonacaine Topical Anesthetic With Menthol 4 g/100g 62221-0935-02 | Filltech | 60 g | — | — | FDA listed | — |
| Topicaine 4 g/100gthis 63135-0312-04 | ESBA | 113 g | — | — | Discontinued | — |
| Comfortcaine 40 mg/g 65008-0005-04 | QS | 1 bottle | — | — | FDA listed | — |
| Greencaine Blast 40 mg/g 69747-0040-01 | ALMA | 113 g | — | — | FDA listed | — |
| Bed Bug Instant Bite Relief 40 mg/g 70466-0001-01 | P.F. | 1 tube | — | — | FDA listed | — |
| Lidocaine 4 g/100mL 71888-0102-02 | Bellus | 12 packets | — | — | FDA listed | — |
| Hunter Beach 4% 4 g/100mL 82517-0002-04 | HUNTERS | 118 ml | — | — | FDA listed | — |
| Hempvana Ultra Strength Pain Relief Cream 4 g/100g 73287-0016-01 | Telebrands | 1 jar | — | — | FDA listed | — |
| Numbsure LIDOCAINE 4 g/100g 83714-0003-01 | Hambli | 1 tube | — | — | FDA listed | — |
| Lidocaine 4 g/100g 42291-0399-30 | AvKARE | 1 tube | — | — | FDA listed | — |
| Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine 4 g/100g 73287-0042-01 | Telebrands | 1 jar | — | — | FDA listed | — |
| RelaxInk LIDOCAINE 4 g/100g 83714-0004-01 | Hambli | 1 tube | — | — | FDA listed | — |
| Anecream 4 g/100g 24357-0701-06 | Focus | 5 tubes | — | — | FDA listed | — |
| Swiftalyn Numbing Cream 4 g/100g 87013-0002-01 | GENUINE | 50 g | — | — | FDA listed | — |
| Lubricaine 4 g/100g 63135-0727-04 | ESBA | 113 g | — | — | FDA listed | — |
| Numbing Pain Relief 4 g/100g 00363-6261-07 | Walgreen | 1 applicator | — | — | FDA listed | — |
| Recovery Numb 4 g/100g 49436-0099-30 | PURKLENZ | 30 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
🏛️
2003
On the market since
Apr 2003
📍
2026
Currently FDA-listed
23 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.
🔬 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 TOPICAINE (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 45%
Female · 54%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63135-0312-04 You're viewing this | 113 g in 1 TUBE (63135-312-04) | 2003-04-20 | Discontinued by firm |
| 63135-0312-13 | 1 TUBE in 1 BOX (63135-312-13) / 10 g in 1 TUBE | 2003-04-20 | Discontinued by firm |
| 63135-0312-30 | 1 TUBE in 1 BOX (63135-312-30) / 30 g in 1 TUBE | 2003-04-20 | Discontinued by firm |
Pack size FAQ
What quantity is in NDC 63135-0312-04?
NDC 63135-0312-04 contains 113 g — 113 g in 1 tube.
What NDC number is used to bill for this package of TOPICAINE LIDOCAINE 4% 4 g/100g Gel?
Bill NDC 63135-0312-04 — the 11-digit billing format is 63135031204. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 63135-312-04, 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: 63135-0312-04, written without dashes as 63135031204. 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 63135-0312-04, the first segment (63135) is the labeler code FDA assigned to ESBA LABORATORIES INC.; the middle segment (0312) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (63135-0312-13), 1 tube (63135-0312-30). Each has its own NDC and its own page — see the package list near the top of this page.
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 ▾
Uses For the temporary relief of pain.
⏱️ Dosage and Administration ▾
Directions Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.
⚠️ Warnings ▾
Warnings For external use only Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use.
🧪 Active Ingredient ▾
Active ingredient Lidocaine 4% w/w
🧪 Inactive Ingredients ▾
Inactive Ingredients Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40B, Simmondsia Chinensis (Jojoba) Seed Oil, Water
🎯 Purpose ▾
Purpose Topical Anesthetic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.