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Tylenol Precise Cooling Pain Relieving Lidocaine, Menthol 10 mg/g; 40 mg/g Cream, 1 tube — NDC 69968-0793-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tylenol Precise Cooling Pain Relieving Lidocaine, Menthol 10 mg/g; 40 mg/g Cream, 1 tube — NDC 69968-0793-1 (Billing 69968-0793-01)

by Kenvue Brands LLC · 1 TUBE in 1 CARTON / 14.2 g in 1 TUBE

This is a package of 1 tube of Tylenol Precise Cooling Pain Relieving Lidocaine, Menthol 10 mg/g; 40 mg/g Cream from Kenvue Brands LLC, marketed since Jul 2023 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 69968-0793-01
🏷️ FDA NDC (as labeled) 69968-0793-1 billing pads the package segment with a zero
This package
Contains1 tube Pack sizes4 compare ↓
Main listing for product 69968-0793 · Also comes in: 113 g 69968-0793-4 70 g 69968-0793-2 2 tubes 69968-0793-9
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 69968-0793-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69968 labeler · 0793 product · 1 package
Package marketed since
Jul 3, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0074300353395
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69968-0793-1
Product NDC 69968-0793
11-digit billing NDC 69968079301
RxCUI 250912
UNII L7T10EIP3A, 98PI200987
UPC 0074300353395
Application # M017
SPL Set ID fc0a3404-b174-3952-e053-6294a90a1e02
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 2023-07-03
Route TOPICAL
Dosage form CREAM
Substance MENTHOL, UNSPECIFIED FORM; LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 250912
Why two NDCs? The FDA registers this code as 69968-0793-1 — a 5-4-1 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 package segment → 69968-0793-01. 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

🧪 What is this product?

Tylenol Precise Cooling is a topical cream sold over the counter under FDA's OTC monograph rules for external pain relief products. It contains lidocaine, a local anesthetic that numbs the skin, and menthol, which produces a cooling sensation. Together, these ingredients are typically used to temporarily relieve minor pain and discomfort from muscle aches, minor arthritis, and similar conditions when applied directly to the affected area.

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.
Try another pack size: 113 g 70 g 2 tubes
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
69968-0793-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 14.2 g in 1 TUBE 2023-07-03 — Active
69968-0793-04 69968-0793-4 1 TUBE in 1 CARTON / 113 g in 1 TUBE 2023-07-03 — Active
69968-0793-02 69968-0793-2 1 TUBE in 1 CARTON / 70 g in 1 TUBE 2025-11-30 — Active
69968-0793-09 69968-0793-9 2 TUBE in 1 CARTON / 113 g in 1 TUBE 2024-03-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 14.2 g in 1 tube.
What NDC number is used to bill for this package of Tylenol Precise Cooling Pain Relieving Lidocaine, Menthol 10 mg/g; 40 mg/g 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tylenol Precise Cooling Pain Relieving 10 mg/g; 40 mg/gthis 69968-0793-01 Kenvue 1 tube — — FDA listed —
Picklebalm Lidocaine With Menthol Arnica Cucumber Seed 40 mg/g; 10 mg/g 71323-0200-00 Compass 113 g — — FDA listed —
Lidocaine 4% plus Menthol 1% Topical Anesthetic Pain Cream 4.27 g/100g; 1 g/100g 73715-0006-01 MOHNARK 30 g — — Discontinued —
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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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.

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 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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 statescarbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, 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.

Manufacturer & labeler

LabelerKenvue Brands LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio567 products on file

More NDCs from Kenvue Brands LLC labeler code 69968

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses For the temporary relief of pain

⏱️ Dosage and Administration 35 words ▾

Directions use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

⚠️ Warnings 76 words ▾

Warnings For external use only. Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas When using this product ▪ avoid contact with eyes Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days ▪ symptoms 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 16 words ▾

Other Information store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)

🧪 Active Ingredient 10 words ▾

Active Ingredient Lidocaine 4%............................................................................................... Topical analgesic Menthol 1%.................................................................................................. Topical analgesic

🧪 Inactive Ingredients 18 words ▾

Inactive Ingredients carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water

🎯 Purpose 3 words ▾

Purpose Topical analgesic

📄 When Using This Product 23 words ▾

Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas

When using this product ▪ avoid contact with eyes

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days ▪ symptoms clear up and occur again within a few days

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 8 words ▾

Questions? Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL - 70g Tube in carton Label Cooling † Pain Relieving Cream Lidocaine 4% Menthol 1% TYLENOL ® PRECISE ® Fast acting † Powerful targeted pain relief Maximum Strength Lidocaine without a prescription LIGHTLY SCENTED FOR EXTERNAL USE ONLY NET WT

2.5 OZ (70 g) Tylenol_1

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, Menthol — the ingredient across all brands.

Top reported reactions

Pain3,217
Fatigue3,056
Nausea3,046
Headache2,815
Dyspnoea2,181
Pneumonia2,007
Diarrhoea1,981

Age at onset

Neonate144
Infant62
Child366
Adolescent259
Adult4,987
Elderly3,158

Reporter sex

49,320 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,575
Death4,981
Life-threatening4,202
Disabling1,205
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,152 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 ✓ 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 Kenvue Brands LLC. 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 3 other package presentations of this same product, including 1 tube (69968-0793-04), 1 tube (69968-0793-02), 2 tubes (69968-0793-09). 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?
Kenvue Brands 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.
← 69968-0792-01 · Kenvue 69968-0794-04 · Kenvue →
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.