NDC 69968-0538-04 — BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR

🆔 Identity & classification

FDA NDC (as labeled) 69968-0538-4

Product NDC 69968-0538

11-digit billing NDC 69968053804

RxCUI 283083

UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y

UPC 0074300081946

Application # M017

SPL Set ID 0a41ec65-bd0b-4fc6-807d-74f353341cc7

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-06-01

Route TOPICAL

Dosage form CREAM

Substance CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE

Why two NDCs? The FDA registers this code as 69968-0538-4 — 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 → 69968-0538-04. 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.

🏭 Manufacturer & labeler

LabelerKenvue Brands LLC

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code69968

First marketedJun 2018

Product typeHuman Otc Drug

Portfolio564 products on file

🔎 All NDCs from Kenvue Brands LLC

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

🧪 What is this product?

BenGay Ultra Strength is an over-the-counter topical cream containing three active ingredients: camphor, menthol, and methyl salicylate. These ingredients are commonly used together in topical pain-relief products to create a warming or cooling sensation on the skin. Camphor and menthol work as counterirritants, while methyl salicylate functions as a topical analgesic. This product is formulated as a non-greasy cream meant to be applied directly to the skin over areas of minor muscle or joint discomfort.

Patient education

📘 MedlinePlus patient leaflet ↗

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 0A5MM307FC
A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
UNII 8NLQ36F6MM
Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
UNII FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
UNII 7EV65EAW6H
Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
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 statescarbomer, disodium EDTA, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, triethanolamine, 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.

💲 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.

Try another pack size: 57 g 2 tubes

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Good Neighbor Muscle Rub Cream 100 mg/g; 40 mg/g; 300 mg/g 46122-0816-36	Amerisource	1 tube	$0.036	—	Availability likely	—
Leader Ultra Strength Muscle Rub Topical Analgesic 40 mg/g; 100 mg/g; 300 mg/g 70000-0208-01	Cardinal	1 tube	$0.036	—	Availability likely	—
Walgreens Pain Relieving Analgesic 40 mg/g; 100 mg/g; 300 mg/g 00363-1199-01	Walgreen	1 tube	—	—	FDA listed	—
Ultra Strength Muscle Rub 40 mg/g; 100 mg/g; 300 mg/g 10742-6000-01	The	1 tube	—	—	FDA listed	—
Rite Aid Muscle Rub Ultra Strength 40 mg/g; 100 mg/g; 300 mg/g 11822-7957-08	Rite	1 tube	—	—	FDA listed	—
Kroger Muscle Rub Cream 40 mg/g; 100 mg/g; 300 mg/g 30142-0427-02	Kroger	1 tube	—	—	FDA listed	—
AVON HeXashield Pain Relief for Muscle, Back and Joint Cream 100 mg/g; 300 mg/g; 40 mg/g 43136-0102-01	Tai	1 tube	—	—	FDA listed	—
Equate Pain Relieving Ultra Strength 40 mg/g; 100 mg/g; 300 mg/g 49035-0700-01	Wal-Mart	1 tube	—	—	FDA listed	—
XRay Pain Relief 100 mg/g; 40 mg/g; 300 mg/g 50066-0456-20	Genomma	1 tube	—	—	FDA listed	—
Pomada Dragon Pain Relief 100 mg/g; 40 mg/g; 300 mg/g 50066-0622-02	Genomma	1 tube	—	—	FDA listed	—
Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub 40 mg/g; 300 mg/g; 100 mg/g 51316-0982-01	CVS	1 tube	—	—	FDA listed	—
Ultra Pain-A-Trate Pain-Relieving Cream 3.4 g/85g; 8.5 g/85g; 25.5 g/85g 54473-0334-03	Melaleuca,	85 g	—	—	FDA listed	—
Pomada Dragon Pain Relieving 40 mg/g; 100 mg/g; 300 mg/g 55038-0001-02	TELEVISA	1 tube	—	—	FDA listed	—
Family Wellness Ultra Strength Muscle Rub 40 mg/g; 100 mg/g; 300 mg/g 55319-0820-57	FAMILY	1 tube	—	—	FDA listed	—
Coolexa 40 mg/g; 100 mg/g; 300 mg/g 57237-0351-13	Rising	1 tube	—	—	FDA listed	—
CVS Health Muscle Rub Ultra Strength 40 mg/g; 100 mg/g; 300 mg/g 59779-0792-01	CVS	1 tube	—	—	FDA listed	—
Family Care Muscle Rub 40 mg/g; 100 mg/g; 300 mg/g 65923-0987-35	United	1 tube	—	—	FDA listed	—
Bengay Ultra Strength Non-Greasy 40 mg/g; 100 mg/g; 300 mg/gthis 69968-0538-04	Kenvue	1 tube	—	—	FDA listed	—
HealthWise Ultra OTC Strength Pain Relief Cream 40 mg/g; 100 mg/g; 300 mg/g 71101-0070-01	Veridian	1 tube	—	—	FDA listed	—
Meijer Ultra Strength Pain Relieving Topical Analgesic 40 mg/g; 100 mg/g; 300 mg/g 79481-1220-01	Meijer	1 tube	—	—	FDA listed	—
Ultra Strength Topical Pain Relief Cream 100 mg/g; 300 mg/g; 40 mg/g 82729-0006-01	J	57 g	—	—	FDA listed	—
Sync Pro 30 g/1; 4 g/1; 10 g 82944-0400-10	iON	1 tube	—	—	FDA listed	—
Care Lix Pain Relief 4 g/100g; 10 g/100g; 30 g/100g 87371-0001-01	ACQUIRED	57 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

🏛️

2018

On the market since

Jun 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.

🔬 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 CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, and Methyl Salicylate — the ingredient across all brands.

Top reported reactions

Application Site Pain1

Reporter sex

Male · 100%

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 NDC	Description	Marketing start	Status
69968-0538-02	1 TUBE in 1 CARTON (69968-0538-2) / 57 g in 1 TUBE	2018-06-01	Active
69968-0538-04 You're viewing this	1 TUBE in 1 CARTON (69968-0538-4) / 113 g in 1 TUBE	2018-06-01	Active
69968-0538-05	2 TUBE in 1 CARTON (69968-0538-5) / 113 g in 1 TUBE	2018-06-01	Active

Pack size FAQ

What quantity is in NDC 69968-0538-04?

NDC 69968-0538-04 is listed by the FDA — 1 tube in 1 carton / 113 g in 1 tube.

What NDC number is used to bill for this package of BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, and Methyl Salicylate 40 mg/g; 100 mg/g; 300 mg/g Cream?

Bill NDC 69968-0538-04 — the 11-digit billing format is 69968053804. 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 69968-0538-4, 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: 69968-0538-04, written without dashes as 69968053804. 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 69968-0538-04, the first segment (69968) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0538) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Kenvue Brands LLC. 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 2 other package presentations of this same product, including 1 tube (69968-0538-02), 2 tubes (69968-0538-05). 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?

Kenvue Brands 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.

📄 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

🎯 Indications and Usage 20 words ▾

Use temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

⏱️ Dosage and Administration 35 words ▾

Directions use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

⚠️ Warnings 105 words ▾

Warnings For external use only. Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions Ask a doctor before use if you have redness over affected area When using this product avoid contact with eyes or mucous membranes do not bandage tightly Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 10 words ▾

Other information store at 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 16 words ▾

Active ingredient Purpose Camphor 4% Topical analgesic Menthol 10% Topical analgesic Methyl salicylate 30% Topical analgesic

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients carbomer, disodium EDTA, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, triethanolamine, water

🎯 Purpose 16 words ▾

Active ingredient Purpose Camphor 4% Topical analgesic Menthol 10% Topical analgesic Methyl salicylate 30% Topical analgesic

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

🔗 Related NDC lookups

🧪 All Camphor (Synthetic), Menthol, Unspecified Form, And Methyl Salicylate NDCsSame ingredient 🏭 All Kenvue labeler NDCsLabeler code 69968