Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF MENTHOL 37 mg/mL Gel, 89 mL — NDC 66902-114-13 (Billing 66902-0114-13)
by NATURAL ESSENTIALS, INC. · 89 mL in 1 CONTAINER
This is a package of 89 mL of COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF MENTHOL 37 mg/mL Gel from NATURAL ESSENTIALS, INC., marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.
NDC 66902-0114-13
🏷️ FDA NDC (as labeled)
66902-114-13
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 66902-114-13 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 66902 labeler · 114 product · 13 package
- Package marketed since
- Sep 27, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0111280122631
- 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)
66902-114-13
Product NDC
66902-114
11-digit billing NDC
66902011413
RxCUI
1192745
UNII
L7T10EIP3A
UPC
0111280122631
Application #
part348
SPL Set ID
9fcc79e6-8176-4ebc-8602-0649b02fab86
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2018-09-27
Route
TOPICAL
Dosage form
GEL
Substance
MENTHOL
Quick answers
- RxCUI (RxNorm): 1192745
Why two NDCs?
The FDA registers this code as 66902-114-13 — 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 → 66902-0114-13. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about MENTHOL?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 g | 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 66902-0114-13 You're viewing this Main listing | 89 mL in 1 CONTAINER | 2018-09-27 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cold Leaf Nutrition Muscle And Joint Pain Relief 37 mg/mLthis 66902-0114-13 | NATURAL | 89 ml | — | — | FDA listed | — |
| Muscle Freeze Relief 37 mg/g 66902-0410-03 | NATURAL | 85 g | — | — | FDA listed | — |
| Joint and Muscle Relief 37 mg/mL 87282-0001-01 | Smart | 89 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 9E8X80D2L0
A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
-
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 O80TY208ZW
Arnica montana is a plant extract used in some formulations as a flavoring agent or traditional botanical ingredient. It may contribute mild taste or aroma to the product.
-
UNII 5TJD82A1ET
A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
-
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 1Q953B4O4F
Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
-
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
-
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 VIF565UC2G
Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
-
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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also states†Aloe Barbadensis Leaf Extract, †Arnica Montana Extract, Camphor, Carbomer, Ethylhexylglycerin, †llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water. †This symbol before the ingredient indicates certified organic:
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerNATURAL ESSENTIALS, INC.
FDA applicationpart348 (OTC MONOGRAPH NOT FINAL)
Labeler code66902
First marketedSep 2018
Product typeHuman Otc Drug
Portfolio34 products on file
More NDCs from NATURAL ESSENTIALS, INC. labeler code 66902
- Fast Freeze MENTHOL 100 mg/mL Spray NDC 66902-015-04
- Fast Freeze Menthol 35 mg/g Gel NDC 66902-016-01
- Novex Hand Sanitizer BENZALKONIUM CHLORIDE 1.3 mg/mL Liquid NDC 66902-037-25
- X3 Clean Hand Sanitizer BENZALKONIUM CHLORIDE 1.3 mg/mL Liquid NDC 66902-038-02
- Germ Attack 70% Isopropyl Alcohol .7 mL/mL Liquid NDC 66902-070-16
- Germ Attack 91% Isopropyl Alcohol .91 mL/mL Liquid NDC 66902-091-16
- Fast Freeze Pain Relieving Continuous MENTHOL, UNSPECIFIED FORM 89 mg/mL Spray NDC 66902-115-04
- Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM 33 mg/mL Gel NDC 66902-116-03
- Muscle Balm MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) 110 mg/g; 110 mg/g Ointment NDC 66902-142-63
- ICY FREEZE MENTHOL 35 mg/mL Gel NDC 66902-165-03
- Game On Xtreme MENTHOL, UNSPECIFIED FORM 37 mg/g Liquid NDC 66902-166-34
- Still Standing MENTHOL, UNSPECIFIED FORM 100 mg/mL Liquid NDC 66902-167-15
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Do Not Use
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Other Information
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
*USES: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
⏱️ Dosage and Administration ▾
DIRECTIONS: Adults and children 12 years and older Apply and gently massage painful joints and/or muscles. Repeat as needed no more than 4 times a day. Wash hands after each use with cold water
⚠️ Warnings ▾
WARNINGS: Use only as directed. For external use only If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Avoid contact with eyes or mucous membranes Pregnancy - Breast Feeding Warning: If pregnant or breast feeding, ask a physician before use.
Do not use with other topical products Do not use with heating devices Do not use on open wounds, damaged or irritated skin Keep away from excessive heat or open flame. KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN. Accidental ingestion: Seek professional help and contact Poison Control immediately.
🧪 Active Ingredient ▾
ACTIVE INGREDIENTS NATURAL Menthol USP 3.7%
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS: †Aloe Barbadensis Leaf Extract, †Arnica Montana Extract, Camphor, Carbomer, Ethylhexylglycerin, †llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water. †This symbol before the ingredient indicates certified organic:
🎯 Purpose ▾
PURPOSE: TOPICAL ANALGESIC
📄 Do Not Use ▾
Do not use with other topical products Do not use with heating devices Do not use on open wounds, damaged or irritated skin Keep away from excessive heat or open flame.
🤰 If Pregnant or Breast-Feeding ▾
Pregnancy - Breast Feeding Warning: If pregnant or breast feeding, ask a physician before use.
📄 Keep Out of Reach of Children ▾
KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN. Accidental ingestion: Seek professional help and contact Poison Control immediately.
📄 Other Information ▾
OTHER: Store in cool dry area - close cap tight
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - Cold Leaf Nutrition Container Label MUSCLE & JOINT PAIN RELIEF* Leaf Cold Nutrition ALOE AND ARNICA, VITAMIN E AND TEA TREE OIL GREASELESS • VANISHING SCENT • ROLL ON FORMULA NO PARABENS • NO SYNTHETIC FRAGRANCE • NO SULFATES NO PARAFFINS • NO DEA • NO PETROLATUM • NO MINERAL OIL • NO ANIMAL TESTING 89 mL (3 fl oz) Principal Display Panel - Cold Leaf Nutrition Container Label
No label section mentions that — try another word, or open the full label on DailyMed below.
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 MENTHOL — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 63%
Unknown · 0%
Serious outcomes
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.
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 Not Final". 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 NATURAL ESSENTIALS, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NATURAL ESSENTIALS, 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.
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.