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Numbing Cream MENTHOL 1 g/100mL Cream — NDC 85524-2520-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Numbing Cream MENTHOL 1 g/100mL Cream — NDC 85524-2520-2 (Billing 85524-2520-02)

by FlexiGo Inc · 1 BOTTLE in 1 BOX / 60 mL in 1 BOTTLE

This is a package of Numbing Cream MENTHOL 1 g/100mL Cream from FlexiGo Inc, marketed since Oct 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 85524-2520-02
🏷️ FDA NDC (as labeled) 85524-2520-2 billing pads the package segment with a zero
This package
Contains60 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 85524-2520 · Also comes in: 50 mL 85524-2520-4
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

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 85524-2520-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85524 labeler · 2520 product · 2 package
Package marketed since
Oct 16, 2025
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8552425202 0
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85524-2520-2
Product NDC 85524-2520
11-digit billing NDC 85524252002
RxCUI 2475473
UNII L7T10EIP3A
Application # M017
SPL Set ID 4146fd51-b18c-393d-e063-6294a90a4d9a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-16
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 2475473
Why two NDCs? The FDA registers this code as 85524-2520-2 — 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 → 85524-2520-02. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 Read our full Menthol guide →

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: 50 mL
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
85524-2520-02 You're viewing this Main listing 1 BOTTLE in 1 BOX / 60 mL in 1 BOTTLE Sample 2025-10-16 — Active
85524-2520-04 85524-2520-4 1 BOTTLE in 1 BOX / 50 mL in 1 BOTTLE Sample 2025-10-16 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 box / 60 ml in 1 bottle.
What NDC number is used to bill for this package of Numbing Cream MENTHOL 1 g/100mL 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
TriDerma Tea Tree Foot Cream 1 g/100g 10738-0011-91 Genuine 270 g — — FDA listed —
Natures Willow Bug Bite Balm 10 mg/g 73498-0022-01 WB 1 tube — — FDA listed —
Natures Willow Balm Itch Relief Cream 10 mg/g 73498-0028-01 WB 99 g — — FDA listed —
Bclsks NUMBING 1 g/100g 85248-0043-01 Jiangxi 50 g — — FDA listed —
Numbing Cream 1 g/100g 85524-2519-02 FlexiGo 1 bottle — — FDA listed —
Numbing Cream 1 g/100mLthis 85524-2520-02 FlexiGo 1 bottle — — FDA listed —
YYNRHI NUMBING Creams 1 g/100g 85593-0004-01 Guangzhou 60 g — — Discontinued —
Yynrhj Numbing Creams 1 g/100g 85593-0005-01 Guangzhou 60 g — — Discontinued —
Olelon Numbing 1 g/100g 85593-0018-01 Guangzhou 120 g — — Discontinued —
PHIZICO Pain Relief 10 mg/mL 85832-0621-00 ER3 1 bottle — — FDA listed —
Easment DMSO cream 1.15 g/115g 87352-0002-01 Easment 115 g — — 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Menthol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

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

LabelerFlexiGo Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85524
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from FlexiGo Inc labeler code 85524

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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

INDICATIONS & USAGE SECTION INDICATIONS & USAGE SECTION

⏱️ Dosage and Administration 8 words ▾

DOSAGE & ADMINISTRATION SECTION DOSAGE & ADMINISTRATION SECTION

⚠️ Warnings 2 words ▾

WARNINGS Warnings

📦 Storage and Handling 6 words ▾

STORAGE AND HANDLING STORAGE AND HANDLING

🧪 Active Ingredient 6 words ▾

OTC-ACTIVE INGREDIENT SECTION OTC-ACTIVE INGREDIENT SECTION

🧪 Inactive Ingredients 6 words ▾

INACTIVE INGREDIENT SECTION INACTIVE INGREDIENT SECTION

🎯 Purpose 4 words ▾

OTC-PURPOSE SECTION OTC-PURPOSE SECTION

📄 Do Not Use 8 words ▾

OTC-DO NOT USE SECTION OTC-DO NOT USE SECTION

📄 Stop Use and Ask a Doctor If 5 words ▾

OTC-STOP USE SECTION OTC-STOP USE

📄 Keep Out of Reach of Children 12 words ▾

OTC-KEEP OUT OF REACH OF CHILDREN OTC-KEEP OUT OF REACH OF CHILDREN

📄 Package Label / Principal Display Panel 8 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 — the ingredient across all brands.

Top reported reactions

Pain5,185
Nausea4,963
Fatigue4,867
Headache4,439
Product Quality Issue3,919
Dyspnoea3,654
Product Adhesion Issue3,514

Age at onset

Neonate191
Infant95
Child490
Adolescent342
Adult7,266
Elderly4,622

Reporter sex

96,029 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization26,845
Life-threatening6,104
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 8,778 3,353
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 FlexiGo 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 1 bottle (85524-2520-04). 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?
FlexiGo 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.
← 85524-2519-02 · FlexiGo 85524-2523-03 · FlexiGo →
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.