NDC 00363-3036-04 — Walgreens Cool n Heat Lidocaine 4% 1 g/100g;

🆔 Identity & classification

FDA NDC (as labeled) 0363-3036-04

Product NDC 0363-3036

11-digit billing NDC 00363303604

RxCUI 1595624

UNII L7T10EIP3A, V13007Z41A

Application # M017

SPL Set ID ce1b21d6-7aa6-2b18-e053-2995a90a4c91

Established class (EPC) Amide Local Anesthetic; Antiarrhythmic

Physiologic effect Local Anesthesia

Chemical class Amides

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-03-01

Route TOPICAL

Dosage form CREAM

Substance MENTHOL, UNSPECIFIED FORM; LIDOCAINE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 0363-3036-04 — a 4-4-2 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 labeler segment → 00363-3036-04. 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.

🏷️ 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

LabelerWalgreens

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code00363

First marketedMar 2022

Product typeHuman Otc Drug

Portfolio342 products on file

🔎 All NDCs from Walgreens

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

🧪 What is this product?

Walgreens Cool n Heat Lidocaine is a topical cream marketed as an over-the-counter monograph product. It contains lidocaine hydrochloride, a local anesthetic typically used to numb minor pain and discomfort on the skin surface, and menthol, which produces a cooling sensation often used in topical pain-relief products. This combination is commonly found in creams intended for temporary relief of minor muscle aches and joint soreness.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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 H1109Z9J4N
A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
UNII 8CRQ2TH63M
Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
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 R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
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 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.

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

The official label also statesBenzyl alcohol, carbomer, glycerin, hydrogenated lecithin, isopropyl palmitate, polysorbate 80, triethanolamine, 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: 76.5 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Walgreens Cool n Heat 1 g/100g; 4 g/100gthis 00363-3036-04	Walgreens	1 bottle	—	—	FDA listed	—
Triderma Pain Relief 4 g/100g; 1 g/100g 10738-0073-20	Genuine	1 jar	—	—	FDA listed	—
Icy Hot with Lidocaine Pain Relieving .4 g/g; .1 g/g 41167-1710-00	Chattem,	1 tube	—	—	FDA listed	—
Meijer Cold and Hot Pain Relieving Analgesic 40 mg/g; 10 mg/g 41250-0355-01	Meijer	1 bottle	—	—	FDA listed	—
CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus Menthol 40 mg/g; 10 mg/g 59779-0910-01	CVS	1 bottle	—	—	FDA listed	—
Pain Relief 1 mg/100mg; 4 mg/100mg 72042-0001-01	HUMN	1 tube	—	—	FDA listed	—
Workvie 1 g/100g; 4 g/100g 72393-0203-25	Marketites	71 g	—	—	FDA listed	—
Insta Relief Dm 40 mg/mL; 10 mg/mL 72465-0600-00	DM	118 ml	—	—	FDA listed	—
Bakers Best Maximum Strength Pain Relief 40 mg/g; 10 mg/g 76102-0031-02	Baker's	56.7 g	—	—	FDA listed	—
Zylotrol Pain Relieving 4 g/100g; 1 g/100g 76420-0560-04	Asclemed	102 g	—	—	FDA listed	—
SANTO REMEDIO Alivio Pain Relieving Lavender Scent 40 mg/mL; 10 mg/mL 81352-0519-00	SANTO	1 tube	—	—	FDA listed	—
Zylotrol Pain Relieving 4 g/100g; 1 g/100g 81902-0230-01	Whitestone	102 g	—	—	FDA listed	—
BlueStop Max 40 mg/g; 10 mg/g 82714-0002-01	Clavel	1 tube	—	—	FDA listed	—
Rapid Pain-Relief Topical 40 mg/mL; 10 mg/mL 82798-0295-02	NORDIC	60 ml	—	—	FDA listed	—
LidoSync 3.1 g/76.5g; .8 g/76.5g 82944-0200-01	iON	1 bottle	—	—	FDA listed	—
Nervive Pain Relieving Cream 4 g/100g; 1 g/100g 84126-0318-03	The	1 tube	—	—	FDA listed	—
Dermatool Nerve Care 1 g/100g; 4 g/100g 84728-0359-05	Papalo	1 bottle	—	—	FDA listed	—
5Kind DMSO 4 Lidocaine HCl Pain Relieving 40 mg/mL; 10 mg/mL 85978-0929-00	5KIND	118 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

🏛️

2022

On the market since

Mar 2022

📍

2026

Currently FDA-listed

4 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.

🔬 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 Walgreens Cool n Heat (this brand).

Top reported reactions

Nausea35

Pain26

Headache23

Dizziness20

Vomiting19

Hypotension17

Dyspnoea14

Age at onset

Infant1

Adult20

Elderly10

Reporter sex

Male · 44%

Female · 55%

Unknown · 1%

Serious outcomes

Hospitalization141

Life-threatening53

Death30

Disabling21

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
00363-3036-02	1 BOTTLE in 1 CARTON (0363-3036-02) / 76.5 g in 1 BOTTLE	2022-03-01	Active
00363-3036-04 You're viewing this	1 BOTTLE in 1 CARTON (0363-3036-04) / 133 g in 1 BOTTLE	2022-03-23	Active

Pack size FAQ

What quantity is in NDC 00363-3036-04?

NDC 00363-3036-04 is listed by the FDA — 1 bottle in 1 carton / 133 g in 1 bottle.

What NDC number is used to bill for this package of Walgreens Cool n Heat Lidocaine 4% 1 g/100g; 4 g/100g Cream?

Bill NDC 00363-3036-04 — the 11-digit billing format is 00363303604. 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 0363-3036-04, 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: 00363-3036-04, written without dashes as 00363303604. 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 00363-3036-04, the first segment (00363) is the labeler code FDA assigned to Walgreens; the middle segment (3036) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Walgreens. 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 1 bottle (00363-3036-02). 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?

Walgreens 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 4 words ▾

Temporarily relieves minor pain

⏱️ Dosage and Administration 49 words ▾

Adults and children over 12 years of age : Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24 hr period. Before and after applying wash hands with soap and water Children under 12 years must ask a doctor

⚠️ Warnings 33 words ▾

For external use only Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, or for more than one week without consulting a doctor.

🧪 Active Ingredient 5 words ▾

Lidocaine HCL 4% Menthol 1%

🧪 Inactive Ingredients 14 words ▾

Benzyl alcohol, carbomer, glycerin, hydrogenated lecithin, isopropyl palmitate, polysorbate 80, triethanolamine, Vitamin E, water

🎯 Purpose 4 words ▾

Topical anesthetic Topical anagesic

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

🔗 Related NDC lookups

🧪 All Lidocaine 4% NDCsSame ingredient 🏭 All Walgreens labeler NDCsLabeler code 00363 📚 All Amide Local Anesthetic NDCsDrug class 📖 Read the Lidocaine 4% drug informationUses, warnings & side effects