Alocane Emergency Burn Lidocaine Hydrochloride 4 g/100mL Gel, 800 mL
by Quest Products, LLC. · 1 BAG in 1 CARTON (68229-201-13) / 800 mL in 1 BAG (68229-201-15)
NDC 68229-0201-13
🏷️ FDA NDC (as labeled)
68229-201-13
billing pads the product segment with a zero
This package
Contains800 mL
Pack sizes11 compare ↓
Also comes in:
110 mL 68229-0201-02
118.294 mL 68229-0201-10
22 mL 68229-0201-18
24 packets 68229-0201-05
45 packets 68229-0201-07
103.507 ml 68229-0201-08
110 ml 68229-0201-03
124 ml 68229-0201-16
133.081 ml 68229-0201-11
946 ml 68229-0201-14
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 →
⚠️
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
FDA NDC (as labeled)
68229-201-13
Product NDC
68229-201
11-digit billing NDC
68229020113
UNII
V13007Z41A
Application #
M017
SPL Set ID
0c8e65a6-dff3-43b4-a3f1-95deb574ea89
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
2019-03-01
Route
TOPICAL
Dosage form
GEL
Substance
LIDOCAINE HYDROCHLORIDE
GPI-14
90850060104025
GPI class
Alocane Emergency Burn Max Str
GCN Seq No
063983
GCN
99694
HICL code
001478
Ingredient (HICL)
Lidocaine Hcl
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5H
Therapeutic class — specific (HIC3)
Topical Local Anesthetics
AHFS code
72:00.00.00
AHFS class
Local Anesthetics
FDB label name
ALOCANE EMERGENCY BURN 4% SPRY
FDB brand name
Alocane Emergency Burn
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 68229-201-13 — 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 → 68229-0201-13. 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
LabelerQuest Products, LLC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code68229
First marketedMar 2019
Product typeHuman Otc Drug
Portfolio4 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
Label name ALOCANE EMERGENCY BURN 4% SPRY Ingredient Lidocaine Hcl
📗 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Lidocaine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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 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 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 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 M825OX60H9
Hydroxyethyl cellulose is a plant-derived thickener made by chemically treating cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to control texture, and sometimes a film-former for coatings.
-
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 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.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also states1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), 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 system | Per g | Per 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:
110 mL
118.294 mL
22 mL
24 packets
45 packets
103.507 ml
110 ml
124 ml
133.081 ml
946 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Launch Medical 4 g/100mL 54723-0018-01 | Sambria | 30 ml | — | — | FDA listed | — |
| Alocane Emergency Burn 4 g/100mLthis 68229-0201-13 | Quest | 800 ml | — | — | FDA listed | — |
| Ikonik Tonik 4 g/100mL 85132-0001-30 | IKONIK | 1 tube | — | — | FDA listed | — |
| Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving 4 g/100mL 49873-0618-01 | Sato | 1 bottle | — | — | FDA listed | — |
| Painless Tattoo Numbing Cream 4 g/100mL 54723-0020-01 | Sambria | 15 ml | — | — | FDA listed | — |
| Alocane Emergency Burn Pads 4 g/100mL 68229-0403-02 | Quest | 10 pouches | — | — | FDA listed | — |
| Now Numb Numbing Cream 4 g/100mL 54723-0022-02 | Sambria | 5 ml | — | — | 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 | — |
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
🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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.
🔬 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 Alocane Emergency Burn (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 64%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68229-0201-02 | 1 TUBE in 1 CARTON (68229-201-02) / 110 mL in 1 TUBE (68229-201-01) | 2019-03-01 | Active |
| 68229-0201-03 | 110 mL in 1 BOTTLE, SPRAY (68229-201-03) | 2020-03-01 | Active |
| 68229-0201-05 | 24 PACKET in 1 CARTON (68229-201-05) / 3.4 mL in 1 PACKET (68229-201-04) | 2020-03-01 | Active |
| 68229-0201-07 | 45 PACKET in 1 CARTON (68229-201-07) / 3.4 mL in 1 PACKET (68229-201-06) | 2020-03-01 | Active |
| 68229-0201-08 | 103.507 mL in 1 BOTTLE, SPRAY (68229-201-08) | 2020-03-01 | Active |
| 68229-0201-10 | 1 TUBE in 1 CARTON (68229-201-10) / 118.294 mL in 1 TUBE (68229-201-09) | 2019-03-01 | Active |
| 68229-0201-11 | 133.081 mL in 1 BOTTLE, SPRAY (68229-201-11) | 2020-03-01 | Active |
| 68229-0201-13 You're viewing this | 1 BAG in 1 CARTON (68229-201-13) / 800 mL in 1 BAG (68229-201-15) | 2019-03-01 | Active |
| 68229-0201-14 | 946 mL in 1 BOTTLE, PUMP (68229-201-14) | 2019-03-01 | Discontinued by firm |
| 68229-0201-16 | 124 mL in 1 BOTTLE, SPRAY (68229-201-16) | 2022-11-11 | Active |
| 68229-0201-18 | 1 TUBE in 1 CARTON (68229-201-18) / 22 mL in 1 TUBE (68229-201-17) | 2021-12-09 | Active |
Pack size FAQ
What quantity is in NDC 68229-0201-13?
NDC 68229-0201-13 contains 800 mL — 1 bag in 1 carton / 800 ml in 1 bag.
What is the difference between NDC 68229-0201-13 and NDC 68229-0201-10?
Both are Alocane Emergency Burn Lidocaine Hydrochloride 4 g/100mL Gel — the drug itself is identical. NDC 68229-0201-13 is the 800 mL package, while NDC 68229-0201-10 is the 1 tube package.
What NDC number is used to bill for this package of Alocane Emergency Burn Lidocaine Hydrochloride 4 g/100mL Gel?
Bill NDC 68229-0201-13 — the 11-digit billing format is 68229020113. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 68229-201-13, 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: 68229-0201-13, written without dashes as 68229020113. 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 68229-0201-13, the first segment (68229) is the labeler code FDA assigned to Quest Products, LLC.; the middle segment (0201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (13) 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 Quest Products, LLC.. 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 10 other package presentations of this same product, including 1 tube (68229-0201-02), 1 tube (68229-0201-10), 1 tube (68229-0201-18). 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?
Quest Products, 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses For the temporary relief of pain and itching associated with: Sunburn Minor Skin Irritation Minor Burns Cuts & Scrapes Insect Bites
⏱️ Dosage and Administration ▾
Do not use in large quantities, particularly over raw surfaces or blistered areas. Directions: Adults and Children 2 years of age or older: Clean the burn area with mild soap and water Gently apply over bthe burn or wound Use on affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
Directions: Adults and Children 2 years of age or older: Clean the burn area with mild soap and water Gently apply over bthe burn or wound Use on affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
⚠️ Warnings ▾
Warnings For external use only. Avoid contact with eyes. Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away. Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding , ask a health care professional before use.
Do not use in large quantities, particularly over raw surfaces or blistered areas. Directions: Adults and Children 2 years of age or older: Clean the burn area with mild soap and water Gently apply over bthe burn or wound Use on affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
📦 Storage and Handling ▾
Other Information Store at room temperature 15-30°C (59-86°F)
🧪 Active Ingredient ▾
Active Ingredient Lidocaine HCL 4%
🧪 Inactive Ingredients ▾
Inactive Ingredients 1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.
🎯 Purpose ▾
Purpose Topical Analgesic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.