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Pain Relief Menthol 10.5 g/100mL Spray, 89 mL — NDC 69396-0175-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pain Relief Menthol 10.5 g/100mL Spray, 89 mL — NDC 69396-175-03 (Billing 69396-0175-03)

by Trifecta Pharmaceuticals USA, LLC. · 89 mL in 1 BOTTLE, SPRAY

This is a package of 89 mL of Pain Relief Menthol 10.5 g/100mL Spray from Trifecta Pharmaceuticals USA, LLC., marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 69396-0175-03
🏷️ FDA NDC (as labeled) 69396-175-03 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

⚠️
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) 69396-175-03
Product NDC 69396-175
11-digit billing NDC 69396017503
RxCUI 1489073
UNII L7T10EIP3A
UPC 0850058161358
Application # M017
SPL Set ID 493ab515-5cda-7b5a-e063-6294a90a295b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-25
Route TOPICAL
Dosage form SPRAY
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 1489073
Why two NDCs? The FDA registers this code as 69396-175-03 — 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 → 69396-0175-03. 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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69396-0175-03 You're viewing this Main listing 89 mL in 1 BOTTLE, SPRAY 2026-01-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold Therapy Pain Relief Walgreens 10.5 g/100g 00363-4411-85 WALGREEN 85 g — — FDA listed —
Rite Aid Cooling Pain Relief 10.5 g/100g 11822-0639-03 Rite 85 g — — FDA listed —
CVS Pain Relief 10.5 g/100g 51316-0996-10 CVS 85 g — — FDA listed —
Biofreeze 105 mg/mL 59316-0114-10 Reckitt 89 ml — — FDA listed —
Biofreeze Professional 105 mg/mL 59316-0120-20 Reckitt 118 ml — — FDA listed —
Biofreeze 105 mg/mL 59316-0833-10 Reckitt 89 ml — — FDA listed —
Biofreeze Professional 105 mg/mL 59316-0834-20 Reckitt 118 ml — — FDA listed —
Pain Relief 10.5 g/100mLthis 69396-0175-03 Trifecta 89 ml — — FDA listed —
GuruNanda Pain Relief 105 mg/mL 70708-0834-02 GURUNANDA, 1 bottle — — FDA listed —
DCH Cooling Pain Relief 10.5 g/100g 72839-0639-03 Derma 85 g — — FDA listed —
Meijer Pain Relief 10.5 g/100g 79481-0639-03 Meijer 85 g — — FDA listed —
Equate Cold Therapy Pain Relieving 105 mg/g 79903-0430-03 Walmart 85 g — — FDA listed —
Target Up and Up Pain Relief Menthol Topical Analgesic 10.5 g/100g 82442-0430-03 Target 85 g — — FDA listed —
TIDL PAIN RELIEF CRYO THERAPY original formula Spray. 10.5 g/100mL 84214-0001-01 Shenzhen 90 ml — — FDA listed —
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray. 10.5 g/100mL 84214-0006-01 Shenzhen 90 ml — — FDA listed —
TIDL Pain Relief CRYO Therapy Limited Edition 10.5 g/100mL 84214-0008-01 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
Jan 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.

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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII 4YK5Z54AT2
    Denatonium benzoate is a bitter-tasting chemical compound added to medicines to discourage accidental ingestion, especially by children. It serves as a bittering agent with no therapeutic effect on the body.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 7TRV45YZF7
    A plant extract from Japanese knotweed root used as a natural ingredient. It functions as an antioxidant and preservative to help maintain product stability and shelf life.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 7J95K7ID2S
    A plant extract from the roots of Chinese skullcap, used as a natural coloring agent and to add mild flavor to medicines. It may also help preserve the product's stability.
  • 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.

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

The official label also statesCamellia Sinensis leaf extract, Butylene glycol, centella asiatica extract, Chamomilla recutita (Matricaria) flower extract, Dimethyl sulfone, isopropyl myristate, Glycyrrhiza glabra (licorice) root extract, polygonum cuspidatum root extract, Rosmarinus officinais (rosemary) leaf extract, alcohol, Scutellaria caicalensis root extract, Denatonium benzoate, 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

LabelerTrifecta Pharmaceuticals USA, LLC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio16 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.

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Indication Temporary Relief of minor aches and pains of joints and muscles associated with simple backache arthritis strains bruises sprains

⏱️ Dosage and Administration 42 words ▾

Directions Adults and Children: 12 years of age and older, spray on to affected area not more than 3 to 4 times daily. Massage not necessary. Children under 12 years of age: consult a physician wash hands after use with cool water

⚠️ Warnings 29 words ▾

Warnings For External Use Only Contents under pressure. Do not puncture or incinerate Flammable: Keep away from excessive heat or open flame. Do not store at temperature above 120ºF.

📦 Storage and Handling 17 words ▾

Other information Store at (20º-25ºC) (68ºF - 77ºF). Store in a dry place away from direct sunlight

🧪 Active Ingredient 4 words ▾

Active Ingredient Menthol 10.5%

🧪 Inactive Ingredients 42 words ▾

Inactive Ingredients Camellia Sinensis leaf extract, Butylene glycol, centella asiatica extract, Chamomilla recutita (Matricaria) flower extract, Dimethyl sulfone, isopropyl myristate, Glycyrrhiza glabra (licorice) root extract, polygonum cuspidatum root extract, Rosmarinus officinais (rosemary) leaf extract, alcohol, Scutellaria caicalensis root extract, Denatonium benzoate, water.

🎯 Purpose 4 words ▾

Purpose Pain Relieving Spray

📄 When Using This Product 51 words ▾

When using this product When using this product use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if ecessive irritation develops do not bandage tightly or use with heating pad or device

📄 Stop Use and Ask a Doctor If 49 words ▾

Stop use and ask a doctor If you experience pain, swelling or blistering of the skin. Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days Arthritic pain persists for more than 10 days or redness is present

🤰 If Pregnant or Breast-Feeding 11 words ▾

If Pregnant or breast feeding Ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Questions or Comments 5 words ▾

Questions or Comments Call 1-888-296-9067

📄 Package Label / Principal Display Panel 12 words ▾

LABEL 6000 GLOBE MENTHOL

10.5 PERCENT PAIN RELIEF SPRAY 3OZ 022526 CDER

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Trifecta Pharmaceuticals USA, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Trifecta Pharmaceuticals USA, 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.
← 69396-0173-01 · Trifecta 69396-0177-05 · Trifecta →
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.