Home › NDC Lookup › Ingredients › Menthol › 61577-3235-02
SORE NO MORE COOL THERAPY MENTHOL .06 g/g Gel, 907.2 g — NDC 61577-3235-02 package photo

SORE NO MORE COOL THERAPY MENTHOL .06 g/g Gel, 907.2 g

by SOMBRA COSMETICS INC. · 907.2 g in 1 BOTTLE, PUMP (61577-3235-2)
NDC 61577-3235-02
🏷️ FDA NDC (as labeled) 61577-3235-2 billing pads the package segment with a zero
This package
Contains907.2 g Pack sizes8 compare ↓
Also comes in: 5 g 61577-3235-09 28.3 g 61577-3235-08 56.7 g 61577-3235-07 85 g 61577-3235-05 113.4 g 61577-3235-04 113.4 g 61577-3235-06 226.8 g 61577-3235-01
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

⚠️
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

FDA NDC (as labeled) 61577-3235-2
Product NDC 61577-3235
11-digit billing NDC 61577323502
RxCUI 415976
UNII L7T10EIP3A
UPC 0763669143036
Application # M017
SPL Set ID 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-06-14
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Why two NDCs? The FDA registers this code as 61577-3235-2 — 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 → 61577-3235-02. 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.

🏭 Manufacturer & labeler

LabelerSOMBRA COSMETICS INC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code61577
First marketedJun 2016
Product typeHuman Otc Drug
Portfolio12 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

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 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.

🧪 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII 06L18L32G6
    A plant extract from meadowsweet flowers. It's used as a natural flavoring, fragrance, or traditional botanical ingredient in 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 598D944HOL
    A natural oil extracted from grapefruit seeds, used as a flavoring agent and preservative to enhance taste and help prevent spoilage in medicines.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII TI9T76XD44
    A natural flavoring derived from orange fruit peel. It adds orange taste and aroma to the medicine, making it more pleasant to take, while also providing natural color.
  • 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 H32V31VMWY
    A fragrant oil derived from rose petals, used as a flavoring agent and to add pleasant scent to medicines. It may also serve as a skin-conditioning ingredient in topical formulations.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • 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.
  • UNII 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.
  • UNII E2H9ET15AT
    Yucca schidigera root is a plant extract used as a natural flavor masker and foaming agent. It helps reduce bitter tastes and improve how the medicine mixes or disperses in liquids.

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

The official label also statesaloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl 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 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: 5 g 28.3 g 56.7 g 85 g 113.4 g 113.4 g 226.8 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sombra Cool Therapy .06 g/g 61577-3103-01 SOMBRA 85.05 g — — FDA listed —
Sore No More Cool Therapy .06 g/gthis 61577-3235-02 SOMBRA 907.2 g — — FDA listed —
myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol 6 g/100mL 72667-0021-01 Inspec 89 ml — — FDA listed —
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On 6 g/100g 72667-0073-01 Inspec 89 g — — FDA listed —
Mountain Ice Sports Recovery 6 g/100mL 72793-0201-01 Mountainside 6 ml — — FDA listed —
Ireliev Roll On Cool Pain Relief 60 mg/mL 72909-0014-01 Excel 88 ml — — FDA listed —
PlayMakar Roll On Cool Pain Relief 60 mg/mL 72909-0015-01 PlayMakar 88 ml — — FDA listed —
NeuroFreeze 6 g/85g 85622-0511-85 Blue 85 g — — FDA listed —
Re-Leve .06 g/g 61577-3242-04 SOMBRA 113.6 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

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 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 SORE NO MORE COOL THERAPY (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

989 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization333
Death125
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 77 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
61577-3235-01 226.8 g in 1 JAR (61577-3235-1) 2022-05-18 Active
61577-3235-02 You're viewing this 907.2 g in 1 BOTTLE, PUMP (61577-3235-2) 2022-05-18 Active
61577-3235-04 113.4 g in 1 JAR (61577-3235-4) 2022-05-18 Active
61577-3235-05 85 g in 1 BOTTLE, PLASTIC (61577-3235-5) 2022-05-18 Active
61577-3235-06 113.4 g in 1 TUBE (61577-3235-6) 2022-05-18 Active
61577-3235-07 56.7 g in 1 JAR (61577-3235-7) 2022-05-18 Active
61577-3235-08 28.3 g in 1 JAR (61577-3235-8) 2022-05-18 Active
61577-3235-09 5 g in 1 POUCH (61577-3235-9) 2022-05-18 Active

Pack size FAQ

What quantity is in NDC 61577-3235-02?
NDC 61577-3235-02 contains 907.2 g — 907.2 g in 1 bottle, pump.
What is the difference between NDC 61577-3235-02 and NDC 61577-3235-09?
Both are SORE NO MORE COOL THERAPY MENTHOL .06 g/g Gel — the drug itself is identical. NDC 61577-3235-02 is the 907.2 g package, while NDC 61577-3235-09 is the 5 g package.
What NDC number is used to bill for this package of SORE NO MORE COOL THERAPY MENTHOL .06 g/g Gel?
Bill NDC 61577-3235-02 — the 11-digit billing format is 61577323502. 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 61577-3235-2, 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: 61577-3235-02, written without dashes as 61577323502. 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 61577-3235-02, the first segment (61577) is the labeler code FDA assigned to SOMBRA COSMETICS INC.; the middle segment (3235) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 SOMBRA COSMETICS 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 7 other package presentations of this same product, including 5 g (61577-3235-09), 28.3 g (61577-3235-08), 56.7 g (61577-3235-07). 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?
SOMBRA COSMETICS 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.

📄 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 16 words ▾

Uses Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

⏱️ Dosage and Administration 39 words ▾

Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age : consult a doctor.

⚠️ Warnings 58 words ▾

Warnings For external use only . Do not use on wounds or damaged skin. When using this product : avoid bandaging tightly, avoid contact with eyes, keep out of reach of children . Stop use and ask doctor if : condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

🧪 Active Ingredient 5 words ▾

Active Ingredients Menthol USP 6%

🧪 Inactive Ingredients 54 words ▾

Inactive Ingredients aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol

🎯 Purpose 4 words ▾

Purpose Purpose External Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61577-3234-02 · SOMBRA 61577-3242-04 · SOMBRA →
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.