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ElixirLidoFast Lidocaine 5% Cream .05 g/g Cream, 156 g — NDC 84546-0010-04 package photo

ElixirLidoFast Lidocaine 5% Cream .05 g/g Cream, 156 g

by ELIXIR HEALTHCARE USA, LLC. · 156 g in 1 JAR (84546-0010-4)
NDC 84546-0010-04
🏷️ FDA NDC (as labeled) 84546-0010-4 billing pads the package segment with a zero
This package
Contains156 g Pack sizes4 compare ↓
Also comes in: 30 g 84546-0010-01 60 g 84546-0010-02 142 g 84546-0010-03
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) 84546-0010-4
Product NDC 84546-0010
11-digit billing NDC 84546001004
RxCUI 1534792
UNII 98PI200987
Application # M017
SPL Set ID 45de5a3d-06c2-aa02-e063-6294a90a63d3
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 2025-12-01
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
Why two NDCs? The FDA registers this code as 84546-0010-4 — a 5-4-1 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 package segment → 84546-0010-04. 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

LabelerELIXIR HEALTHCARE USA, LLC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code84546
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio8 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 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.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.

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

The official label also statesBenzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Trolamine, Vitamin E Acetate, Purified Water

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.
Try another pack size: 30 g 60 g 142 g
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
Lidocaine 50 mg/g 58980-0823-30 STRATUS 1 tube — — FDA listed —
Adellina Tattoo Numbing Cream 5 g/100g 60771-0010-01 Guangzhou 50 g — — Discontinued —
Adellina Numbing Cream 5 g/100mL 60771-0011-01 Guangzhou 44 ml — — FDA listed —
Lipocaine 5 5 g/100g 63135-0811-04 ESBA 113 g — — FDA listed —
Microcaine Topical Analgesic 50 mg/g 67194-0022-01 Unit 15 g — — FDA listed —
Hempvana Maximum Strength Pain Relief Topical Anesthetic 5 g/100g 73287-0026-01 Telebrands 1 jar — — FDA listed —
Lidocaine 5 g/100mL 73581-0022-06 YYBA 170 ml — — FDA listed —
Lidocaine Numbing Cream 50 mg/mL 73581-0105-55 Yyba 156 ml — — FDA listed —
Lidocaine 5 g/100mL 73581-0114-01 YYBA 30 ml — — FDA listed —
Numbing Cream 5 g/100mL 82929-0011-01 Sainite 1 bottle — — FDA listed —
Healcome Lidocaine Numbing Cream 5 g/100g 83364-0024-01 YITONGBADA 1 bottle — — FDA listed —
Pressy Tattoo Numbing Cream 5 g/100g 83887-0008-01 Changsha 60 g — — Discontinued —
Tattoo Numbing Cream 5 g/100mL 83887-0009-01 Changsha 60 ml — — Discontinued —
Lidocaine 5% 5 g/100g 84007-0335-01 Medhome 30 g — — FDA listed —
Signature Lidocaine Pain Relief Cream 50 mg/g 84019-0043-01 Shengnan 30 g — — FDA listed —
ElixirLidoFast .05 g/gthis 84546-0010-04 ELIXIR 156 g — — FDA listed —
VTROUY Tattoo Numbing Cream 5 g/100g 85150-0004-01 Guangzhou 50 g — — FDA listed —
Dr.pabu Numbing 5 g/100g 85248-0177-01 Jiangxi 50 g — — FDA listed —
Tattoo numbing 3 g/60g 85342-0002-01 Guangzhou 60 g — — Discontinued —
Arlun LIDOCAINE Cream 5 g/100g 87408-0021-01 Guangzhou 1 bottle — — 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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 ElixirLidoFast (this brand).

Top reported reactions

Accident At Home1
Application Site Burn1
Chemical Burn1
Chest Discomfort1
Cough1
Death1
Diabetes Mellitus1

Reporter sex

14 reports
Male · 7%
Female · 93%

Serious outcomes

Hospitalization5
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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
84546-0010-01 1 TUBE in 1 CARTON (84546-0010-1) / 30 g in 1 TUBE 2025-12-01 Active
84546-0010-02 1 TUBE in 1 CARTON (84546-0010-2) / 60 g in 1 TUBE 2025-12-01 Active
84546-0010-03 142 g in 1 JAR (84546-0010-3) 2025-12-01 Active
84546-0010-04 You're viewing this 156 g in 1 JAR (84546-0010-4) 2025-12-01 Active

Pack size FAQ

What quantity is in NDC 84546-0010-04?
NDC 84546-0010-04 contains 156 g — 156 g in 1 jar.
What is the difference between NDC 84546-0010-04 and NDC 84546-0010-03?
Both are ElixirLidoFast Lidocaine 5% Cream .05 g/g Cream — the drug itself is identical. NDC 84546-0010-04 is the 156 g package, while NDC 84546-0010-03 is the 142 g package.
What NDC number is used to bill for this package of ElixirLidoFast Lidocaine 5% Cream .05 g/g Cream?
Bill NDC 84546-0010-04 — the 11-digit billing format is 84546001004. 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
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 84546-0010-4, 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: 84546-0010-04, written without dashes as 84546001004. 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 84546-0010-04, the first segment (84546) is the labeler code FDA assigned to ELIXIR HEALTHCARE USA, LLC.; the middle segment (0010) 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 ELIXIR HEALTHCARE USA, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (84546-0010-01), 1 tube (84546-0010-02), 142 g (84546-0010-03). 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?
ELIXIR HEALTHCARE USA, LLC. 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 15 words ▾

Uses Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorder.

⏱️ Dosage and Administration 64 words ▾

Dosage • If pregnant or breastfeeding: ask a health professional before use.

Directions apply liberally as often as necessary For diaper rash: • change wet or soiled diapers promptly • cleanse the diaper area and allow to dry • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

⚠️ Warnings 6 words ▾

Warnings: • For external use only

🧪 Active Ingredient 8 words ▾

Active Ingredient (in each gram) Lidocaine 5% w/w

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Trolamine, Vitamin E Acetate, Purified Water

🎯 Purpose 4 words ▾

Purpose Anorectal (hemorrhoidal) cream

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84546-0007-01 · ELIXIR 84549-0001-25 · ProPharma →
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.