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Burn Gel Lidocaine HCI .02 g/g Gel, 144 packets — NDC 69396-0106-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Burn Gel Lidocaine HCI .02 g/g Gel, 144 packets — NDC 69396-106-09 (Billing 69396-0106-09)

by Trifecta Pharmaceuticals USA LLC · 144 PACKET in 1 CARTON / .9 g in 1 PACKET

This is a package of 144 packets of Burn Gel Lidocaine HCI .02 g/g Gel from Trifecta Pharmaceuticals USA LLC, marketed since Sep 2022 and currently FDA-listed. It is this product's only package size.

NDC 69396-0106-09
🏷️ FDA NDC (as labeled) 69396-106-09 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69396-106-09
Product NDC 69396-106
11-digit billing NDC 69396010609
NCPDP billing unit EA — each (per item)
RxCUI 1011852
UNII V13007Z41A
UPC 0850026393484
Application # M017
SPL Set ID e9d3e9be-1036-fad0-e053-2a95a90a6efe
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 2022-09-27
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1011852
Why two NDCs? The FDA registers this code as 69396-106-09 — 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 → 69396-0106-09. 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
  • It depends on the product. Injections numb areas for procedures, IV lidocaine treats dangerous heart rhythms, and skin products relieve minor pain and itching. Check which product...
  • Most are applied in a thin layer to the affected area a few times a day. Limits and age rules vary by product, so read your label and follow your prescriber.
  • Most come from too much lidocaine in the blood. They include dizziness, drowsiness, nervousness, ringing in the ears, and blurred vision.
  • Seek help for seizures, trouble breathing, hives or swelling, or bluish skin. Also report loss of bladder or bowel control after an epidural.
📖 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69396-0106-09 You're viewing this Main listing 144 PACKET in 1 CARTON / .9 g in 1 PACKET 2022-09-27 — Active

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 $0.898 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/100g 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/gthis 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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

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

The official label also statesAloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate

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

LabelerTrifecta Pharmaceuticals USA LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedSep 2022
Product typeHuman Otc Drug
Portfolio67 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Uses Temporary pain relief for minor burns. For professional use only.

⏱️ Dosage and Administration 32 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: do not use, consult a doctor

⚠️ Warnings 26 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

📦 Storage and Handling 17 words ▾

Storage Information Store at room temperature (do not freeze) do not use any opened or torn packets

🧪 Active Ingredient 5 words ▾

Active Ingredient Lidocaine HCL 2%

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate

🎯 Purpose 4 words ▾

Purpose Topical Pain Relief

📄 Stop Use and Ask a Doctor If 28 words ▾

Stop Use and Ask a doctor if The condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Questions or Comments 3 words ▾

Questions? Call 1-888-296-9067

📄 Package Label / Principal Display Panel 10 words ▾

LABEL 4048 GLOBE BURN GEL 0.9G 144 CT 082826 CDER

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 Trifecta Pharmaceuticals USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Trifecta Pharmaceuticals 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.
← 69396-0105-09 · Trifecta 69396-0107-02 · Trifecta →
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.