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Lidocaine Hydrochloride 20 mg/mL Liquid, 59.1 mL — NDC 61010-5100-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocaine Hydrochloride 20 mg/mL Liquid, 59.1 mL — NDC 61010-5100-4 (Billing 61010-5100-04)

by Safetec of America, Inc. · 59.1 mL in 1 BOTTLE, SPRAY

This is a package of 59.1 mL of Lidocaine Hydrochloride 20 mg/mL Liquid from Safetec of America, Inc., marketed since Aug 2011 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 61010-5100-04
🏷️ FDA NDC (as labeled) 61010-5100-4 billing pads the package segment with a zero
This package
Contains59.1 mL Pack sizes2 compare ↓
Main listing for product 61010-5100 · Also comes in: 118 ml 61010-5100-5
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61010-5100-4
Product NDC 61010-5100
11-digit billing NDC 61010510004
RxCUI 1010769
UNII V13007Z41A
Application # M017
SPL Set ID 8eb3e7e2-26e5-430e-89aa-40a0367c637e
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 2011-08-02
Route TOPICAL
Dosage form LIQUID
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1010769
Why two NDCs? The FDA registers this code as 61010-5100-4 — 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 → 61010-5100-04. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with 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.

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.
Try another pack size: 118 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61010-5100-04 You're viewing this Main listing 59.1 mL in 1 BOTTLE, SPRAY 2011-08-02 — Active
61010-5100-05 61010-5100-5 118 mL in 1 BOTTLE, SPRAY 2011-08-02 — Active

Pack size FAQ

What quantity is in this package?
This package contains 59.1 mL — 59.1 ml in 1 bottle, spray.
How does this package differ from NDC 61010-5100-05?
Both are Lidocaine Hydrochloride 20 mg/mL Liquid — the drug itself is identical. This page's package is the 59.1 mL one, while NDC 61010-5100-05 is the 118 ml package.
What NDC number is used to bill for this package of Lidocaine Hydrochloride 20 mg/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Hydrochloride 20 mg/mL 00924-0934-01 Acme 59.1 ml — — FDA listed —
Lightning Products BURN RELIEF 2 g/100mL 43473-0070-01 Nantong 59.1 ml — — FDA listed —
2.0% Lidocaine Burn 2 g/100mL 43473-0097-02 Nantong 59.1 ml — — FDA listed —
Everlit Care Products Burn Relief 2 g/100mL 43473-0111-01 Nantong 59.1 ml — — FDA listed —
MediFirst Burn 20 g/L 47682-0225-02 Unifirst 0591 l — — FDA listed —
Medi-First Burn 20 g/L 47682-0255-02 Unifirst 0591 l — — FDA listed —
Lidocaine Hydrochloride 20 g/L 47682-0308-02 Unifirst 0591 l — — FDA listed —
Green Guard Burn 20 g/L 47682-0330-02 Unifirst 0591 l — — FDA listed —
UniShield First Aid Burn 20 mg/mL 49314-0002-01 Unishield 59.1 ml — — FDA listed —
2.0% Lidocaine Burn 2 g/100mL 52000-0441-02 Universal 59.1 ml — — FDA listed —
Lidotral Two Percent 20 mg/mL 59088-0304-03 PureTek 30 ml — — FDA listed —
Burn Mist 2 g/100mL 59898-0201-10 Water-Jel 59 ml — — FDA listed —
Lidocaine Hydrochloride 20 mg/mLthis 61010-5100-04 Safetec 59.1 ml — — FDA listed —
Regenecare Ha 20 mg/mL 66977-0117-04 MPM 120 ml — — FDA listed —
Lidocaine Hydrochloride 20 g/L 68421-5100-01 Cintas 0591 l — — FDA listed —
Burn Relief 20 g/L 69396-0107-02 Trifecta 0591 l — — FDA listed —
American Safety First Aid 20 mg/mL 71927-0012-01 Orazen 59.1 ml — — FDA listed —
First Shield 20 mg/mL 72976-0004-01 Ever 60 ml — — FDA listed —
Burn 20 mg/mL 73598-0671-01 JHK 59.1 ml — — FDA listed —
GREEN GUARD Topical Pain Relief 20 mg/mL 78495-0132-01 Ultra 59.1 ml — — FDA listed —
MEDI-FIRST Topical Analgesic 20 mg/mL 78495-0142-01 Ultra 59.1 ml — — FDA listed —
Everlit Care Products Burn Relief 2 g/100mL 83807-0032-01 EVERLIT 59.1 ml — — FDA listed —
Lidocaine Hydrochloride 20 mg/mL 84269-3500-01 Wildman 59.1 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

🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 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.

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 H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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 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.

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

The official label also statesaloe vera, germaben II, propylene glycol, purified water Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com PAIN RELIEF – Burn Spray  Safetec of America Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ----------

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.

Manufacturer & labeler

LabelerSafetec of America, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code61010
First marketedAug 2011
Product typeHuman Otc Drug
Portfolio33 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.

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 Temporary pain relief for minor burns

⏱️ Dosage and Administration 38 words ▾

Directions for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily for children under 2 years of age consult a physician

⚠️ Warnings 65 words ▾

Warnings For external use only Do not use in large quantities, particularly over raw or blistered areas near eyes, if this happens rinse thoroughly with water Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

🧪 Active Ingredient 5 words ▾

Active ingredients Lidocaine HCl 2.0%

🧪 Inactive Ingredients 62 words ▾

Inactive ingredients aloe vera, germaben II, propylene glycol, purified water Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com PAIN RELIEF – Burn Spray Safetec of America Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ----------

🎯 Purpose 4 words ▾

Purpose Topical pain relief

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Safetec of America, Inc.. 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 1 other package presentation of this same product, including 118 ml (61010-5100-05). 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?
Safetec of America, 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.
← 61010-5000-00 · Safetec 61010-5111-00 · Safetec →
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.