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SunBurnt PLUS LIDOCAINE HYDROCHLORIDE 4 g/100mL Gel — NDC 68229-601-02 (Billing 68229-0601-02)

by Quest Products, LLC. · 1 TUBE in 1 CARTON / 118 mL in 1 TUBE

This is a package of SunBurnt PLUS LIDOCAINE HYDROCHLORIDE 4 g/100mL Gel from Quest Products, LLC., marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 68229-0601-02
🏷️ FDA NDC (as labeled) 68229-601-02 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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68229-601-02
Product NDC 68229-601
11-digit billing NDC 68229060102
NCPDP billing unit ML — per mL (volume)
RxCUI 1010077
UNII V13007Z41A
Application # M017
SPL Set ID 12128c75-015d-8a72-e063-6394a90ae00a
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 2024-02-23
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 077663
GCN 43754
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 SUNBURNT PLUS PAIN RLF 4% GEL
FDB brand name Sunburnt Plus Pain Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 077663
  • GCN: 43754
  • HICL (First Databank): 001478
  • AHFS class code: 72:00.00.00
  • RxCUI (RxNorm): 1010077
Why two NDCs? The FDA registers this code as 68229-601-02 — 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 → 68229-0601-02. 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

Label name SUNBURNT PLUS PAIN RLF 4% GEL Ingredient Lidocaine Hcl
📗 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
68229-0601-02 You're viewing this Main listing 1 TUBE in 1 CARTON / 118 mL in 1 TUBE 2024-02-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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/100mLthis 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/100g 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 —
Launch Medical 4 g/100mL 54723-0018-01 Sambria 30 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 —
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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 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.

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.

Manufacturer & labeler

LabelerQuest Products, LLC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code68229
First marketedFeb 2024
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.

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 19 words ▾

Uses Temporarily relieves pain and itching due to: sunburn minor burns insect bites minor skin irritations minor cuts scrapes

⏱️ Dosage and Administration 36 words ▾

Directions clean skin and apply to affected area adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily children under 2 years of age: ask a doctor

⚠️ Warnings 98 words ▾

Warnings For external use only Do not use in large quantities, particularly over raw surfaces or blistered areas if you have an allergy or hypersensitivity to any ingredients Ask a doctor before use if you have severe sunburn you have a rash or broken or compromised skin When using this product Avoid contact with eyes Stop use and ask a doctor condition worsens symptoms last more than 7 days or 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 right away.

📦 Storage and Handling 17 words ▾

Other Information store at 15-30°C (59-86°F) do not use if seal under cap is open or missing

🧪 Active Ingredient 5 words ▾

Active Ingredient Lidocaine Hydrochloride 4%

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

🎯 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 ↗

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 SunBurnt PLUS (this brand).

Top reported reactions

Infusion Site Pain729
Nausea491
Infusion Site Erythema456
Headache438
Dyspnoea426
Diarrhoea423
Fatigue369

Reporter sex

6,521 reports
Male · 35%
Female · 64%
Unknown · 1%

Serious outcomes

Life-threatening735
Disabling131
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,366 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 — 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 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 Quest Products, LLC.. Listing status can change — the directory data on this page refreshes weekly.
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.
← 68229-0600-01 · Quest 68229-0700-20 · Quest →
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.