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Walgreens Cool n heat Lidocaine 4% Menthol 1% 4 g/100g; 1 g/100g Aerosol, Spray, 113 g — NDC 00363-3033-04 package photo

Walgreens Cool n heat Lidocaine 4% Menthol 1% 4 g/100g; 1 g/100g Aerosol, Spray, 113 g

by Walgreens · 113 g in 1 BOTTLE, SPRAY (0363-3033-04)
NDC 00363-3033-04
🏷️ FDA NDC (as labeled) 0363-3033-04 billing pads the labeler segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0363-3033-04
Product NDC 0363-3033
11-digit billing NDC 00363303304
RxCUI 1595448
UNII 98PI200987, L7T10EIP3A
Application # M017
SPL Set ID ce168ab7-ec4a-daea-e053-2995a90af829
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 2022-07-19
Route TOPICAL
Dosage form AEROSOL, SPRAY
Substance LIDOCAINE; MENTHOL
Why two NDCs? The FDA registers this code as 0363-3033-04 — 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 → 00363-3033-04. 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 marketedJul 2022
Product typeHuman Otc Drug
Portfolio342 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

🧪 What is this product?

Walgreens Cool n Heat is a topical aerosol spray containing lidocaine and menthol. Lidocaine is a local anesthetic commonly used to numb or reduce sensation in the area where it is applied, while menthol is often included in topical products for its cooling sensation. This combination is typically used to provide temporary relief of minor pain and discomfort on the skin. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for this category of topical pain-relief sprays.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.

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

The official label also statescaprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30%)

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 systemPer mLPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Cool n heat 4 g/100g; 1 g/100gthis 00363-3033-04 Walgreens 113 g — — FDA listed —
Icy Hot Lidocaine Dry 4 g/100mL; 1 g/100mL 41167-1740-02 Chattem, 113 ml — — FDA listed —
CVS Cold and Hot Pain Relief Dry 40 mg/g; 10 mg/g 51316-0483-04 CVS 113 g — — FDA listed —
HealthWise Max Lidocaine plus Menthol 4 g/100mL; 1 g/100mL 71101-0079-01 Veridian 113 ml — — FDA listed —
Picklebalm Lidocaine With Menthol Arnica Cucumber Seed 40 mg/mL; 10 mg/mL 71323-0203-00 Compass 118 ml — — FDA listed —
DCH Nerve Pain Relief 4 g/100g; 1 g/100g 72839-0223-05 Derma 142 g — — FDA listed —
Tidl Pain Relief Evening Therapy Spray. 1 g/100mL; 4 g/100mL 84214-0007-01 Shenzhen 90 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
Jul 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

456 reports
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
2019 2021 2023 2026 32 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00363-3033-04 You're viewing this 113 g in 1 BOTTLE, SPRAY (0363-3033-04) 2022-07-19 Active

🧭 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 0363-3033-04, 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: 00363-3033-04, written without dashes as 00363303304. 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 00363-3033-04, the first segment (00363) is the labeler code FDA assigned to Walgreens; the middle segment (3033) 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.
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 46 words ▾

Adults and Children over 12 years: Spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period Product will dry quickly on its own, and does not need to be rubbed in Children 12 years and younger: Ask a doctor

⚠️ Warnings ~1 min read ▾

For External Use Only Do not use: on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor Extremely Flammable: Do not use near heat or flame or while smoking Avoid long term storage above 104° F (40°C) do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120° F (49°C) When using this product: use only as directed. Read and follow all directions and warnings on this label do not allow contact with the eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin avoid spraying on face avoid inhalation of spray do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use do not use the same time as other topical analgesics a transient burning sensation may occur upon application but generally disappears in several days avoid applying into skin folds Stop use and ask a doctor if : conditions worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

🧪 Active Ingredient 4 words ▾

Lidocaine 4% Menthol 1%

🧪 Inactive Ingredients 9 words ▾

caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30%)

🎯 Purpose 4 words ▾

Topical Anesthetic Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00363-3031-04 · Walgreens 00363-3034-07 · Walgreens →
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.