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MEDI-FIRST Topical Analgesic Lidocaine HCI 20 mg/mL Spray, 59.1 mL — NDC 78495-0142-01 package photo

MEDI-FIRST Topical Analgesic Lidocaine HCI 20 mg/mL Spray, 59.1 mL

by Ultra Distributors Inc · 59.1 mL in 1 BOTTLE, PUMP (78495-142-01)
NDC 78495-0142-01
🏷️ FDA NDC (as labeled) 78495-142-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 78495-142-01
Product NDC 78495-142
11-digit billing NDC 78495014201
UNII V13007Z41A
UPC 0347682225025
Application # M017
SPL Set ID b6f288f7-9ae3-215e-e053-2a95a90aedf6
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 2020-12-19
Route TOPICAL
Dosage form SPRAY
Substance LIDOCAINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 78495-142-01 — 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 → 78495-0142-01. 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

LabelerUltra Distributors Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code78495
First marketedDec 2020
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
  • Lidocaine numbs just the area being worked on without affecting your whole body the way general anesthesia does. It blocks pain signals right at the nerve, so you stay awake and al...
  • Why does my doctor use lidocaine instead of putting me fully to sleep for a procedure?
  • Topical lidocaine products are meant for intact minor skin injuries — things like small burns, scrapes, insect bites, or skin irritations. You should only apply them to the area de...
  • Can I use the over-the-counter cream or spray on any part of my body?
📖 Read our full Lidocaine Hci 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • 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.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 7JPC6Y25QS
    A synthetic nonionic surfactant, a type of cleaning agent used in pharmaceutical formulations. It functions as an emulsifier and solubilizer, helping mix water and oil-based ingredients and improving how the medicine dissolves and spreads in the body.
  • 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 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • 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 VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • 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.

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

The official label also statesaminomethyl propanol, glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, 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 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.
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 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/mL 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/mLthis 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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 MEDI-FIRST Topical Analgesic (this brand).

Top reported reactions

Abdominal Distension2
Asthenia2
Diarrhoea2
Fatigue2
Nausea2
Abdominal Pain1
Acne1

Reporter sex

9 reports
Male · 33%
Female · 67%

Serious outcomes

Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 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
78495-0142-01 You're viewing this 59.1 mL in 1 BOTTLE, PUMP (78495-142-01) 2020-12-19 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 78495-142-01, 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: 78495-0142-01, written without dashes as 78495014201. 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 78495-0142-01, the first segment (78495) is the labeler code FDA assigned to Ultra Distributors Inc; the middle segment (0142) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Ultra Distributors Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ultra Distributors 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 8 words ▾

Uses Temporary pain relief associated with minor burns

⏱️ Dosage and Administration 29 words ▾

Directions spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily not to be used on Children under 12 years of age

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 5 words ▾

Active ingredient Lidocaine HCI 2.0%

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients aminomethyl propanol, glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, water

🎯 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 ↗
← 78495-0132-01 · Ultra 78495-0162-01 · Ultra →
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.