Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Burn Relief Professional Bio-Kool Lidocaine - 4% 4 g/100g Cream, 113 g — NDC 61566-201-04 (Billing 61566-0201-04)
by Kool-Down Inc. · 113 g in 1 BOTTLE
This is a package of 113 g of Burn Relief Professional Bio-Kool Lidocaine - 4% 4 g/100g Cream from Kool-Down Inc., marketed since Jan 2013 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 61566-0201-04
🏷️ FDA NDC (as labeled)
61566-201-04
billing pads the product segment with a zero
This package
Contains113 g
Pack sizes2 compare ↓
Main listing for product 61566-201 · Also comes in:
128 g 61566-201-14
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
61566-201-04
Product NDC
61566-201
11-digit billing NDC
61566020104
UNII
98PI200987
UPC
0043399806075
Application #
M017
SPL Set ID
827e9c69-4706-0ccf-e053-2991aa0aa1c1
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
2013-01-15
Route
TOPICAL
Dosage form
CREAM
Substance
LIDOCAINE
Quick answers
- RxCUI (RxNorm): 1421893
Why two NDCs?
The FDA registers this code as 61566-201-04 — 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 → 61566-0201-04. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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?
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Lidocaine - 4%?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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:
128 g
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 61566-0201-04 You're viewing this Main listing | 113 g in 1 BOTTLE | 2013-01-15 | — | Active |
| 61566-0201-14 61566-201-14 | 128 g in 1 JAR | 2025-06-23 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This package contains 113 g — 113 g in 1 bottle.
How does this package differ from NDC 61566-0201-14?
Both are Burn Relief Professional Bio-Kool Lidocaine - 4% 4 g/100g Cream — the drug itself is identical. This page's package is the 113 g one, while NDC 61566-0201-14 is the 128 g package.
What NDC number is used to bill for this package of Burn Relief Professional Bio-Kool Lidocaine - 4% 4 g/100g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Lidocaine 4 g/100g 00536-1357-95 | Rugby | 1 tube | $0.428 | — | Availability likely | — |
| Lidocaine 4% Topical Anesthetic Cream 4 g/100g 83720-0523-01 | Oncor | 1 tube | $0.490 | — | Availability likely | — |
| 4 Lidocaine Topical Anesthetic 40 mg/g 00536-1267-20 | RUGBY | 15 g | $0.635 | — | Availability likely | — |
| Lidocaine 40 mg/g 39328-0024-15 | Patrin | 1 tube | $0.635 | — | Availability likely | — |
| Numbing Pain Relief 4 g/100g 00363-6261-07 | Walgreen | 1 applicator | — | — | FDA listed | — |
| Lmx4 40 mg/g 00496-0882-05 | Ferndale | 5 g | — | — | FDA listed | — |
| Lidocaine 40 mg/g 10135-0672-96 | Marlex | 1 tube | — | — | FDA listed | — |
| Anecream 4 g/100g 24357-0701-06 | Focus | 5 tubes | — | — | FDA listed | — |
| Meijer Analgesic Lidocaine Topical Analgesic 40 mg/g 41250-0518-01 | Meijer | 1 bottle | — | — | FDA listed | — |
| Lidocaine 4 g/100g 42291-0399-30 | AvKARE | 1 tube | — | — | FDA listed | — |
| Pain free IV 4 g/100mL 54723-0008-01 | Sambria | 4 ml | — | — | FDA listed | — |
| Painless Tattoo 2 4 g/100mL 54723-0016-01 | Sambria | 4 ml | — | — | FDA listed | — |
| NeuroMed Topical Anesthetic 7 40 mg/g 54723-0300-04 | Sambria | 4 g | — | — | FDA listed | — |
| Family Wellness Pain Relief with Lidocaine 40 mg/g 55319-0822-50 | FAMILY | 1 tube | — | — | FDA listed | — |
| Lidocaine 40 mg/g 58980-0824-05 | Stratus | 1 tube | — | — | FDA listed | — |
| Burn Relief Professional Bio-Kool 4 g/100gthis 61566-0201-04 | Kool-Down | 113 g | — | — | FDA listed | — |
| Desert Harvest RELEVEUM 40 mg/mL 69145-0201-04 | Desert | 118 ml | — | — | FDA listed | — |
| Lidocaine Anesthetic Cream 4 g/100g 69375-0005-30 | Nationwide | 1 tube | — | — | FDA listed | — |
| Tylenol Precise Warming Pain Relieving 40 mg/g 69968-0794-04 | Kenvue | 1 tube | — | — | FDA listed | — |
| Tylenol Precise Pain Relieving 40 mg/g 69968-0795-04 | Kenvue | 1 tube | — | — | FDA listed | — |
| Blue-Emu Lidocaine Pain Relief Cream 40 mg 69993-0350-03 | Kingsway | 1 tube | — | — | FDA listed | — |
| Lidocaine Cream, 4% 4 g/100g 71085-0075-19 | IPG | 119 g | — | — | FDA listed | — |
| Deeveeant Numb 40 mg/g 71383-0014-02 | Valekista | 1 tube | — | — | FDA listed | — |
| MediNumb 40 mg/g 71383-0024-02 | Valekista | 1 tube | — | — | FDA listed | — |
| Asper Flex 4 g/100g 71399-0049-01 | Akron | 15 g | — | — | FDA listed | — |
| Lidocaine 4% 4 g/100g 71800-0026-06 | Innovida | 58.5 g | — | — | FDA listed | — |
| Lidozall 4 g/100g 72835-0004-20 | V2 | 20 packets | — | — | FDA listed | — |
| Lidocaine 4% Topical Anesthetic Cream 4.27 g/100g 73715-0001-01 | Mohnark | 30 g | — | — | Discontinued | — |
| Meijer Pain Relief Cream 4 g/100g 79481-0048-02 | Meijer | 76.5 g | — | — | FDA listed | — |
| Lidocaine 40 mg/g 80425-0351-01 | Advanced | 1 tube | — | — | FDA listed | — |
| Lidocaine 4% Cream 40 mg/g 82461-0419-30 | Medcore | 1 tube | — | — | FDA listed | — |
| AUVON Pain Relief Cream 4 g/100g 83391-0009-01 | SHENZHEN | 57 g | — | — | FDA listed | — |
| RelaxInk LIDOCAINE 4 g/100g 83714-0004-01 | Hambli | 1 tube | — | — | FDA listed | — |
| ELAIMEI Numbing Cream 4 g/100mL 83804-0005-01 | Shenzhen | 1 bottle | — | — | FDA listed | — |
| Tktalker Numbing 4 g/100g 83804-0113-01 | Shenzhen | 50 g | — | — | FDA listed | — |
| Dcsily Numbing Cream 4 g/100g 83818-0034-01 | Shenzhen | 50 g | — | — | FDA listed | — |
| 4% TATTOO Numb Cream 100 mg/g 84019-0030-01 | Shengnan | 30 g | — | — | FDA listed | — |
| Signature Pain Relief Cream 40 mg/g 84019-0044-01 | Shengnan | 30 g | — | — | FDA listed | — |
| Nekvnro LIDOCAINE 4% Tattoo numbing cream set 4 g/100g 84844-0018-01 | Guoyu | 2 tubes | — | — | Discontinued | — |
| VBBV Tattoo Numbing 40 mg/mL 84867-0014-01 | Jiashen | 60 ml | — | — | FDA listed | — |
| Black Cobra Tattoo Numbing Cream 4% Lidocaine .04 g/g 84938-0002-01 | Foshan | 20 g | — | — | FDA listed | — |
| Jakwork Numbing Cream 4 g/100g 85150-0007-01 | Guangzhou | 50 g | — | — | FDA listed | — |
| Healmusz Numbing 4 g/100g 85248-0032-01 | Jiangxi | 50 g | — | — | FDA listed | — |
| Nieapf NUMBING 4 g/100g 85248-0046-01 | Jiangxi | 65 g | — | — | FDA listed | — |
| Subleef NUMBING 4 g/100g 85248-0052-01 | Jiangxi | 30 g | — | — | FDA listed | — |
| Sylvirene Numbing 4 g/100g 85248-0070-01 | Jiangxi | 50 g | — | — | FDA listed | — |
| ANIXIKE Numbing 4 g/100g 85248-0088-01 | Jiangxi | 30 g | — | — | FDA listed | — |
| Dermfree Numbing 4 g/100g 85248-0121-01 | Jiangxi | 50 g | — | — | FDA listed | — |
| ANIXIKE Numbing 4 g/100g 85248-0166-01 | Jiangxi | 30 g | — | — | FDA listed | — |
| YYSDMVY NUMBING Cream 4 g/100g 85248-0209-01 | Jiangxi | 60 g | — | — | FDA listed | — |
| Tattoo numbing cream 4 g/100g 85284-0001-01 | BLOOMWELL | 50 g | — | — | FDA listed | — |
| Topical Cream 4 g/100g 85284-0002-01 | BLOOMWELL | 50 g | — | — | Discontinued | — |
| Numbing Cream 4 g/100g 85284-0003-01 | BLOOMWELL | 50 g | — | — | Discontinued | — |
| numbing cream MAXIMUM STRENGTH 4 g/100g 85284-0006-01 | BLOOMWELL | 50 g | — | — | Discontinued | — |
| Veiurkiu External Analgesic Cream 4 g/100g 85284-0011-01 | BLOOMWELL | 50 g | — | — | FDA listed | — |
| Numbing Cream 40 mg/g 85569-0001-01 | 100 | 50 g | — | — | FDA listed | — |
| Numbing Cream 4 mg/100mL 85569-0002-01 | 100 | 50 ml | — | — | FDA listed | — |
| SCHOELIF Numbing Cream 4 g/100g 85817-0001-01 | Guangzhou | 50 g | — | — | FDA listed | — |
| Aouiv 4% Lidocaine Numbing Cream 4 g/100g 85817-0003-01 | Guangzhou | 60 g | — | — | FDA listed | — |
| Numbing Creams 4 g/100g 85881-0001-01 | Yongchun | 50 g | — | — | FDA listed | — |
| Black Cobra 4% Lidocaine Numbing Cream 40 mg/g 85924-0001-02 | BLACKCOBRASUPPLY, | 1 tube | — | — | Discontinued | — |
| Swiftalyn Numbing Cream 4 g/100g 87013-0002-01 | GENUINE | 50 g | — | — | FDA listed | — |
| Morovan 4 g/100g 87800-2624-01 | HONG | 1 can | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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.
- FDA Orange Book · refreshed Sep 3, 2026
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 344S277G0Z
Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
-
UNII 66YXD4DKO9
A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
-
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 PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
-
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 Q1LS2UJO3A
Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
-
UNII H5RIZ3MPW4
A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
-
UNII A1A1I8X02B
A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
-
UNII MP1J8420LU
A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
-
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 FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
-
UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
-
UNII SOI2LOH54Z
Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.
19 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesAloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerKool-Down Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code61566
First marketedJan 2013
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Temporarily relieves pain due to: sunburns, burns, insect bites, and itching.
⏱️ Dosage and Administration ▾
Adults and children 5 years of age and older: apply to affected area, not more than 3-4 times daily. Children under 5 years of age: ask a doctor.
⚠️ Warnings ▾
For external use only. Do not use in large quantities, particularity over raw surfaces or blistered areas When using this product keep out of eyes, use only as directed Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.
🧪 Active Ingredient ▾
Lidocaine - 4.0%
🧪 Inactive Ingredients ▾
Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.
🎯 Purpose ▾
Topical Pain Reliever
📄 Keep Out of Reach of Children ▾
Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
label image description
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 ↗
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 - 4% — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
Unknown · 0%
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.
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 Kool-Down Inc.. 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 1 other package presentation of this same product, including 128 g (61566-0201-14). 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?
Kool-Down Inc. 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.
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.