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CVS Pain Relief Menthol 10.5% 10.5 g/100g Spray, 128 g — NDC 51316-0996-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS Pain Relief Menthol 10.5% 10.5 g/100g Spray, 128 g — NDC 51316-996-04 (Billing 51316-0996-04)

by CVS · 128 g in 1 BOTTLE, SPRAY

This is a package of 128 g of CVS Pain Relief Menthol 10.5% 10.5 g/100g Spray from CVS, marketed since Sep 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 51316-0996-04
🏷️ FDA NDC (as labeled) 51316-996-04 billing pads the product segment with a zero
This package
Contains128 g Pack sizes2 compare ↓
Main listing for product 51316-996 · Also comes in: 85 g 51316-996-10
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 51316-996-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51316 labeler · 996 product · 04 package
Package marketed since
Mar 31, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0050428109441, 0050428651049
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51316-996-04
Product NDC 51316-996
11-digit billing NDC 51316099604
RxCUI 1489073
UNII L7T10EIP3A
UPC 0050428109441, 0050428651049
Application # M017
SPL Set ID d0ea80ce-38b2-acde-e053-2995a90a47e5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-13
Route TOPICAL
Dosage form SPRAY
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 1489073
Why two NDCs? The FDA registers this code as 51316-996-04 — 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 → 51316-0996-04. 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.
Try another pack size: 85 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51316-0996-10 51316-996-10 85 g in 1 BOTTLE, SPRAY 2022-09-13 — Active
51316-0996-04 You're viewing this Main listing 128 g in 1 BOTTLE, SPRAY 2025-03-31 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 128 g — 128 g in 1 bottle, spray.
How does this package differ from NDC 51316-0996-10?
Both are CVS Pain Relief Menthol 10.5% 10.5 g/100g Spray — the drug itself is identical. This page's package is the 128 g one, while NDC 51316-0996-10 is the 85 g package.
What NDC number is used to bill for this package of CVS Pain Relief Menthol 10.5% 10.5 g/100g Spray?
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
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/100gthis 51316-0996-04 CVS 128 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/100mL 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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 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.

🧪 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 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 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 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 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 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 BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product 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.

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

The official label also statesAloe Barbadensis leaf Juice, Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Dimethyl Sulphone (MSM), Isobutane, Propylene Glycol, SD Alcohol 40 B (30%), 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

LabelerCVS
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedSep 2022
Product typeHuman Otc Drug
Portfolio100 products on file

More NDCs from CVS labeler code 51316

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Temporary relief from minor aches of sore muscles and joints associated with: Arthritis Backache Strains Sprains

⏱️ Dosage and Administration 32 words ▾

Adults and children 12 years of age and older: Spray on to the affected areas not more than 4 times daily; message not necessary Children under 12 years of age: Consult physician

⚠️ Warnings 28 words ▾

For external use only Flammable: Keep away from excessive heat or open flames. Contents Under Pressure. Do Not Puncture Or Incinerate Do Not Store At Temperature Above 120°F

🧪 Active Ingredient 2 words ▾

Menthol 10.5%

🧪 Inactive Ingredients 24 words ▾

Aloe Barbadensis leaf Juice, Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Dimethyl Sulphone (MSM), Isobutane, Propylene Glycol, SD Alcohol 40 B (30%), Water

🎯 Purpose 2 words ▾

Topical analgesic

📄 Ask a Doctor Before Use If 10 words ▾

Ask a Doctor before using if you have sensitive skin

📄 When Using This Product 66 words ▾

When using this product: Use only as directed Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin Do not bandage Do not use with heating pad or device Store in a cool dry place away from sunlight Wash hands after use with cool water

📄 Stop Use and Ask a Doctor If 26 words ▾

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

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 13 words ▾

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

📄 Package Label / Principal Display Panel 5 words ▾

4.5 oz label Package Label

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 CVS Pain Relief (this brand).

Top reported reactions

Pain3,231
Fatigue3,094
Nausea3,067
Headache2,847
Dyspnoea2,232
Pneumonia2,040
Diarrhoea2,005

Age at onset

Neonate144
Infant62
Child364
Adolescent259
Adult4,984
Elderly3,215

Reporter sex

49,522 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,785
Death5,052
Life-threatening4,235
Disabling1,212
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,463 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 CVS. 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 85 g (51316-0996-10). 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?
CVS 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.
← 51316-0994-03 · CVS 51316-0997-04 · CVS →
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.