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Burn Ease, 3.5g 2 g/100g Gel, 2000 packets

by ProStat First Aid LLC · 2000 PACKET in 1 CARTON (58228-3883-1) / 3.5 g in 1 PACKET
NDC 58228-3883-01
🏷️ FDA NDC (as labeled) 58228-3883-1 billing pads the package 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) 58228-3883-1
Product NDC 58228-3883
11-digit billing NDC 58228388301
RxCUI 1011852
UNII V13007Z41A
Application # M017
SPL Set ID 004aa18f-3a97-f454-e063-6394a90afcff
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 2023-07-31
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 58228-3883-1 — 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 → 58228-3883-01. 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.

🏷️ 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

LabelerProStat First Aid LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code58228
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio27 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.

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 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
Lidocaine Hydrochloride 20 mg/mL 76329-3013-05 International 25 vials $0.704 AT Availability likely —
glydo 20 mg/mL 25021-0673-76 Sagent 10 syringes $0.887 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 76329-3011-05 International 25 vials $1.167 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 76329-3012-05 International 25 vials $1.167 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 00404-9898-10 Henry 1 vial — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00404-9899-20 Henry 1 vial — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00404-9900-05 Henry 1 vial — AT FDA listed —
First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g 00924-5004-00 Acme 3.5 g — — FDA listed —
First Aid Only Burn 20 mg/g 00924-5010-00 Acme 3.5 g — — FDA listed —
Burn 20 mg/g 43473-0048-01 Nantong 9 g — — FDA listed —
PO First Aid Series BURN 2 g/100g 43473-0062-01 Nantong 9 g — — FDA listed —
JJ Care BURN 2 g/100g 43473-0069-01 Nantong 9 g — — FDA listed —
Lightning X Burn Relief Gel 2 g/100g 43473-0121-01 Nantong 9 g — — FDA listed —
Medi-First Burn 20 mg/g 47682-0477-69 Unifirst 6 packets — — FDA listed —
Lidocaine Hci 20 mg/mL 51662-1389-01 HF 5 ml — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 51662-1551-03 HF 25 pouches — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 51662-1552-03 HF 25 pouches — AT FDA listed —
Burn Ease 2 g/100g 58228-2010-01 ProStat 25 packets — — FDA listed —
PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-2012-01 ProStat 25 packets — — FDA listed —
Burn Ease Cooling 2 g/100g 58228-2893-05 ProStat 2000 packets — — FDA listed —
Burn Ease 2 g/100g 58228-3831-02 ProStat 20 packets — — FDA listed —
Burn Ease 2 g/100g 58228-3832-02 ProStat 6 packets — — FDA listed —
PS-3866 Burn Ease, 0.9g 2 g/100g 58228-3866-01 ProStat 10 packets — — FDA listed —
PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-3867-01 ProStat 10 packets — — FDA listed —
Burn Ease, 3.5g 2 g/100gthis 58228-3883-01 ProStat 2000 packets — — FDA listed —
PS-3885 Burn Ease, 3.5g 2 g/100g 58228-3885-01 ProStat 6 packets — — FDA listed —
Burn Ease 2 g/100g 58228-6210-01 Front 25 packets — — FDA listed —
FL Burn Ease, 0.9g 2 g/100g 58228-6212-01 ProStat 25 packets — — FDA listed —
Burn Ease 3.5g 2 g/100g 58228-6231-01 Front 20 packets — — FDA listed —
Burn Ease 3.5g 2 g/100g 58228-6232-01 Front 6 packets — — FDA listed —
Burn Ease 3.5g 2 g/100g 58228-6283-01 Front 2000 packets — — FDA listed —
Lidoease 2% 20 mg/g 59088-0221-03 PureTek 28.35 g — — FDA listed —
Burn Jel 2 g/100mL 59898-0200-11 Water-Jel 24 bottles — — FDA listed —
Lidocaine Hydrochloride 20 mg/g 61010-5000-00 Safetec 3.3 g — — FDA listed —
Aloe Ice Sunburn Relief 2 g/100mL 61477-0101-11 Aloe 60 ml — — FDA listed —
Regenecare Ha 20 mg/g 66977-0107-03 MPM 85 g — — FDA listed —
XeroBurn Burn Gel 2 g/100g 67777-0129-02 Dynarex 1728 packets — — FDA listed —
Burn Gel .02 g/g 69396-0106-09 Trifecta 144 packets — — FDA listed —
Redicare Burn Gel 20 mg/g 71105-0500-02 Redicare 15 packets — — FDA listed —
Jelcaine Sterile 20 mg/mL 71351-0025-30 Brookfield 30 ml — — FDA listed —
Lidocaine 20 mg/mL 72485-0611-10 ARMAS 1 tube — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 76329-3015-05 International 25 vials — AT FDA listed —
Burn 20 mg/g 82942-1001-01 J&A 9 g — — FDA listed —
Lidomax 20 mg/g 85477-0304-07 Oncora 85 g — — FDA listed —
Collavera 20 mg/g 85477-0305-07 Oncora 28.33 g — — FDA listed —
Lidocaine Hydrochloride 2% 2 g/100g 87236-0015-35 Aldermed 25 packets — — 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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
58228-3883-01 You're viewing this 2000 PACKET in 1 CARTON (58228-3883-1) / 3.5 g in 1 PACKET 2023-07-31 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 — Not published for this NDC No photo available yet for this listing.
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.
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 58228-3883-1, 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: 58228-3883-01, written without dashes as 58228388301. 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 58228-3883-01, the first segment (58228) is the labeler code FDA assigned to ProStat First Aid LLC; the middle segment (3883) 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 ProStat First Aid LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ProStat First Aid 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 14 words ▾

Use(s) For the temporary relief of pain associated with • Minor burns • Sunburn

⏱️ Dosage and Administration 33 words ▾

Directions • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: Consult a doctor

⚠️ Warnings 89 words ▾

Warnings For External Use Only. Do not use • On wounds or damaged skin • In large quantities, particularly over raw surfaces or blistered areas When using this product • Avoid contact with the eyes • Do not bandage tightly Stop use and ask a doctor if • Condition worsens • Symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Lidocaine Hydrochloride 2%

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

🎯 Purpose 2 words ▾

Purpose Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58228-3867-01 · ProStat 58228-3885-01 · ProStat →
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.