NDC 51316-0483-04 — CVS Cold and Hot Pain Relief Dry Lidocaine

🆔 Identity & classification

FDA NDC (as labeled) 51316-483-04

Product NDC 51316-483

11-digit billing NDC 51316048304

RxCUI 1595448

UNII 98PI200987, L7T10EIP3A

UPC 0050428489710

Application # M017

SPL Set ID 4b333300-1ae7-a080-e063-6394a90a1372

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 2026-02-19

Route TOPICAL

Dosage form SPRAY

Substance LIDOCAINE; MENTHOL, UNSPECIFIED FORM

Why two NDCs? The FDA registers this code as 51316-483-04 — 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 → 51316-0483-04. 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

LabelerCVS Pharmacy

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code51316

First marketedFeb 2026

Product typeHuman Otc Drug

Portfolio550 products on file

🔎 All NDCs from CVS Pharmacy

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?

This is an over-the-counter topical spray containing lidocaine and menthol, marketed under FDA's OTC drug monograph rules. Lidocaine is a local anesthetic typically used to numb minor pain on the skin surface, while menthol is a cooling agent commonly used to produce a soothing sensation. Together, these ingredients are typically used in products designed for temporary relief of minor aches and pains.

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 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 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.

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

The official label also statesAlcohol Denatured, Caprylic/Capric Triglyceride, Propylene Glycol

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 mL	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.

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 4 g/100g; 1 g/100g 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/gthis 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

🏛️

2026

On the market since

Feb 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

·

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 Lidocaine, Menthol — the ingredient across all brands.

Top reported reactions

Pain3,219

Fatigue3,057

Nausea3,046

Headache2,815

Dyspnoea2,183

Pneumonia2,008

Diarrhoea1,980

Age at onset

Neonate144

Infant62

Child366

Adolescent259

Adult4,987

Elderly3,158

Reporter sex

Male · 37%

Female · 63%

Unknown · 0%

Serious outcomes

Hospitalization17,578

Death4,981

Life-threatening4,206

Disabling1,205

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
51316-0483-04 You're viewing this	113 g in 1 CAN (51316-483-04)	2026-02-19	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 51316-483-04, 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: 51316-0483-04, written without dashes as 51316048304. 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 51316-0483-04, the first segment (51316) is the labeler code FDA assigned to CVS Pharmacy; the middle segment (0483) 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 CVS Pharmacy. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

CVS Pharmacy 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 5 words ▾

Use temporarily relieves minor pain

⏱️ Dosage and Administration 48 words ▾

Directions shake well adults and children 12 years of age and older: spray product on area not more than 1 to 3 times daily product will dry quickly on its own, and does not need to be rubbed in children under 12 years of age: ask a doctor

⚠️ Warnings 185 words ▾

Warnings For external use only Flammable: do not use while smoking or near heat or flame avoid long term storage above 104°F (40°C) do not sore at temperatures above 120 °F (49°C) Do not use on large areas of the body on cut, damaged, irritated or swollen skin more than one week without sonsulting a doctor When using this product use only as directed rare cases of serious burns have been reported with products of this type do not allow contact with eyes or mucous membranes avoid spraying on face avoid inhalation of spray do not bandage tightly do not use with a heating pad or other topical pain relief products contents under pressure do not puncture or incinerate.

Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days needed for longer than a week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active ingredients Lidocaine 4% Menthol 1%

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients Alcohol Denatured, Caprylic/Capric Triglyceride, Propylene Glycol

🎯 Purpose 5 words ▾

Purposes Topical Analgesic Topical Analgesic

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, Menthol NDCsSame ingredient 🏭 All CVS labeler NDCsLabeler code 51316 📚 All Amide Local Anesthetic NDCsDrug class

CVS Cold and Hot Pain Relief Dry Lidocaine, Menthol 40 mg/g; 10 mg/g Spray, 113 g

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups