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Burn Relief Aloe Lidocaine HCl 4 g/100g Gel, 113 g — NDC 80551-0001-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Burn Relief Aloe Lidocaine HCl 4 g/100g Gel, 113 g — NDC 80551-001-03 (Billing 80551-0001-03)

by Acutens · 113 g in 1 BOTTLE

This is a package of 113 g of Burn Relief Aloe Lidocaine HCl 4 g/100g Gel from Acutens, marketed since Mar 2021 and currently FDA-listed. It is this product's only package size.

NDC 80551-0001-03
🏷️ FDA NDC (as labeled) 80551-001-03 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 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

NDC database record

One package, one record: these facts belong to NDC 80551-001-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
80551 labeler · 001 product · 03 package
Package marketed since
Mar 18, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8055100103 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80551-001-03
Product NDC 80551-001
11-digit billing NDC 80551000103
RxCUI 1010077
UNII V13007Z41A
Application # M017
SPL Set ID 48c435fe-2670-4b80-bf01-923dc9354422
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 2021-03-18
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1010077
Why two NDCs? The FDA registers this code as 80551-001-03 — 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 → 80551-0001-03. 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 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
80551-0001-03 You're viewing this Main listing 113 g in 1 BOTTLE 2021-03-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader 4 g/100g 70000-0098-01 Cardinal 1 bottle $0.052 — Availability likely —
Lidocaine HCL 4 g/100g 87137-0101-07 Matthias 1 bottle $0.052 — Availability likely —
GNP Lidocaine Maximum Strength 4 g/100g 46122-0614-10 AMERISOURCE 1 bottle $0.052 — Availability likely —
Walgreens Burn 4 g/100g 00363-2020-25 WALGREENS 1 tube — — FDA listed —
Walgreens Cool n Heat Lidocaine 4 g/100g 00363-7801-02 Walgreens 71 g — — FDA listed —
Roll-On Pain Relief Liquid 4 g/100g 42507-0916-01 HyVee 73 g — — FDA listed —
Alocane Emergency Burn 4 g/100mL 68229-0201-02 Quest 1 tube — — FDA listed —
SunBurnt PLUS 4 g/100mL 68229-0600-01 Quest 1 tube — — Discontinued —
SunBurnt PLUS 4 g/100mL 68229-0601-02 Quest 1 tube — — FDA listed —
Pain Relief Gel-Roll On 40 g/L 69396-0188-01 Trifecta 1 bottle — — FDA listed —
CVS Maximum Strength Burn 4 g/100g 69842-0309-25 CVS 1 tube — — FDA listed —
Derma Numb Pain Relief 40 mg/g 70188-0005-01 A.T.S. 28 g — — FDA listed —
DermaNumb Analgesic 40 mg/g 70188-0006-01 A.T.S. 57 g — — FDA listed —
Lidovyx 40 mg/g 72835-0447-01 V2 70 g — — FDA listed —
DCH Pain Relief Roll-On 4 g/100g 72839-0087-02 Derma 1 bottle — — FDA listed —
Warrior Pain Relief Roll-On Maximum Strength 4 g/100g 72839-0108-02 Derma 71 g — — FDA listed —
Warrior Burn Relief Aloe Maximum Strength 4 g/100mL 72839-0185-04 Derma 118 ml — — FDA listed —
Relief Gel 4 g/100mL 73716-0003-05 Good 5 ml — — FDA listed —
Mirakel Pain Relief Roll-On 4 g/100g 78589-0257-03 Sanvio, 85 g — — FDA listed —
Meijer Pain Relief 4 g/100g 79481-1087-02 Meijer 71 g — — FDA listed —
Burn Relief Aloe 4 g/100gthis 80551-0001-03 Acutens 113 g — — FDA listed —
Pomg Night Time Pain Relief Roller 40 mg/mL 84615-0007-02 POMG 1 bottle — — FDA listed —
LidoGuard 4 g/100g 85231-0200-30 ViolaCare, 1 tube — — FDA listed —
Inkorporated Numbing 4 g/100g 70171-0028-01 Prodigy 1 jar — — FDA listed —
Do Me Delay 4 g/100g 70171-0051-01 Prodigy 1 tube — — FDA listed —
NumbR-X 4 g/100g 70171-0001-01 Prodigy 1 jar — — FDA listed —
Pure Primal Delay 4 g/100g 70171-0060-01 Prodigy 1 tube — — FDA listed —
CVS Lidocaine Maximum Strength 4 g/100g 69842-0921-49 CVS 1 bottle — — FDA listed —
Westlake Lidocaine 4 g/100g 82895-0717-50 Westlake 1 bottle — — FDA listed —
Dr Tatty Numbing 4 g/100g 70171-0020-01 Prodigy 1 jar — — FDA listed —
Dr Lido 4 g/100g 70171-0002-01 Prodigy 1 jar — — FDA listed —
Inked Inspired 4 g/100g 70171-0003-01 Prodigy 1 jar — — FDA listed —
TattooGirl Numbing 4 g/100g 70171-0021-01 Prodigy 1 tube — — FDA listed —
InkKulture Numbing 4 g/100g 70171-0022-01 Prodigy 1 tube — — FDA listed —
QC Lidocaine Maximum Strength 4 g/100g 63868-0956-01 Chain 1 bottle — — FDA listed —
Aspercreme Lidocaine with Eucalyptus Essential Oil 4 g/100g 41167-0566-00 Chattem, 1 tube — — FDA listed —
Ink Scribd Numbing 4 g/100g 70171-0029-01 Prodigy 1 jar — — FDA listed —
Blt 2 4 g/100g 70372-0728-01 CENTURA 5 g — — FDA listed —
LidoGuard 4 g/100g 73492-0272-30 ALAINA 1 tube — — 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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.

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.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII T7SWE4S2TT
    Cetyl hydroxyethylcellulose is a thickening agent and film-former made by modifying plant cellulose. It's used in topical medicines to increase texture, improve spreadability, and help create a protective barrier on skin.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Extract Avena Sativa (Oat) Kernel Extract Blue 1 Caprylyl Glycol Chlorphenesin Dimethyl Isosorbide Glycerin Hydroxyethylcellulose Isopropyl Alcohol Phenoxyethanol Polysorbate 20 Propanediol Tocopheryl Acetate 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.

Manufacturer & labeler

LabelerAcutens
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code80551
First marketedMar 2021
Product typeHuman Otc Drug
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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses: For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

⏱️ Dosage and Administration 31 words ▾

Direction adults and children over 2 years and older : • Apply to affected area not more than 3-4 times a day • Children under 2 years old: consult a doctor

⚠️ Warnings 57 words ▾

Warnings For external use only When using this product • Avoid contact with eyes. Rinse with water if contact occurs. Stop use and ask doctor if • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered area

🧪 Active Ingredient 7 words ▾

Active ingredients Purpose LIDOCAINE HYDROCHLORIDE Pain Reliever

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients Aloe Barbadensis Leaf Extract Avena Sativa (Oat) Kernel Extract Blue 1 Caprylyl Glycol Chlorphenesin Dimethyl Isosorbide Glycerin Hydroxyethylcellulose Isopropyl Alcohol Phenoxyethanol Polysorbate 20 Propanediol Tocopheryl Acetate Water

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 2 words ▾

image description

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine HCl Viscous (matched by generic name) — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lidocaine HCl Viscous. CMS lists 5 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.02M
Claims incl. refills
110.4K
Beneficiaries
87.1K
Spend / beneficiary
$23.19
Spend / claim
$18.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Lidocaine HCl — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity415
Pain162
Nausea105
Toxicity To Various Agents97
Dizziness87
Fatigue86
Headache79

Age at onset

Neonate7
Infant2
Child1
Adolescent2
Adult145
Elderly65

Reporter sex

3,202 reports
Male · 35%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization651
Death241
Life-threatening165
Disabling64
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 363 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.

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 Acutens. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Acutens 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.
← 80539-0001-39 · Allwell 80569-0084-15 · Triple →
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.