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Bengay Ultra Strength Large Size Menthol, Unspecified Form 50 mg Patch, 1 patch — NDC 69968-0487-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bengay Ultra Strength Large Size Menthol, Unspecified Form 50 mg Patch, 1 patch — NDC 69968-0487-1 (Billing 69968-0487-01)

by Kenvue Brands LLC · 1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH

This is a package of 1 patch of Bengay Ultra Strength Large Size Menthol, Unspecified Form 50 mg Patch from Kenvue Brands LLC, no longer marketed (first marketed Apr 2019), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 69968-0487-01
🏷️ FDA NDC (as labeled) 69968-0487-1 billing pads the package segment with a zero
This package
Contains1 patch Pack sizes2 compare ↓
Main listing for product 69968-0487 · Also comes in: 4 patches 69968-0487-4
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69968-0487-1
Product NDC 69968-0487
11-digit billing NDC 69968048701
NCPDP billing unit EA — each (per item)
RxCUI 420222
UNII L7T10EIP3A
Application # M017
SPL Set ID f57ccc33-400b-4401-a348-c54d1eb9f5d0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2019-04-03
Route TOPICAL
Dosage form PATCH
Substance MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 420222
Why two NDCs? The FDA registers this code as 69968-0487-1 — 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 → 69968-0487-01. 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 eachPer 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: 4 patches
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
69968-0487-01 You're viewing this Main listing 1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH 2019-04-03 — Discontinued by firm
69968-0487-04 69968-0487-4 4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH 2019-09-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 patch — 1 pouch in 1 carton / 1 patch in 1 pouch.
How does this package differ from NDC 69968-0487-04?
Both are Bengay Ultra Strength Large Size Menthol, Unspecified Form 50 mg Patch — the drug itself is identical. This page's package is the 1 patch one, while NDC 69968-0487-04 is the 4 patches package.
What NDC number is used to bill for this package of Bengay Ultra Strength Large Size Menthol, Unspecified Form 50 mg Patch?
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
Extra Strength Cold-Hot Medicated Patches 5 g 70000-0367-01 Cardinal 5 patches $0.772 — FDA listed —
Rugby Menthol Hot Cold Patch 5 g/100g 00536-1332-15 RUGBY 5 patches $1.023 — Availability likely —
Good Neighbor Pharmacy Cold Therapy Pain Relief Patch 5 g/100g 46122-0751-45 Amerisource 5 patches $1.023 — Availability likely —
Walgreens Cool N Heat Back Patch 50 mg/g 00363-6657-05 Walgreen 5 patches — — FDA listed —
Walgreens Cold Therapy Pain Relieving Patch 50 mg/g 00363-6669-05 Walgreen 5 patches — — FDA listed —
Walgreens Cool N Heat Patch XL 50 mg/g 00363-6672-03 Walgreen 3 patches — — FDA listed —
Hot and Cold Medicated Patch 5 g/100g 00363-9520-05 Walgreen 5 pouches — — FDA listed —
Extra Large Cool and Heat Patch 5 g/100g 00363-9905-03 Walgreen 3 pouches — — FDA listed —
Walgreens Cold Therapy Pain Relief Patch 5 g/100g 00363-9950-05 Walgreens 5 patches — — FDA listed —
Cold and Hot Medicated 500 mg 10742-1117-01 The 5 patches — — FDA listed —
Cold and Hot Medicated 240 mg 10742-1118-01 The 5 patches — — FDA listed —
WellPatch Cooling Pain Relief 50 mg 10742-8125-01 The 1 patch — — Discontinued —
Up and Up Cold and Hot Medicated 50 mg 11673-0887-05 TARGET 1 patch — — Discontinued —
Extra Strength Cold and Hot Menthol Patch 5 g/100g 11822-6513-01 Rite 5 patches — — FDA listed —
Rite Aid Hot and Cold Back Patch 5 g/100g 11822-9991-03 Rite 3 patches — — FDA listed —
Signature Care Cold and Hot Medicated 50 mg 21130-0980-01 Safeway 5 patches — — FDA listed —
Signature Care Medicated Cold and Hot Patch 5 g/100g 21130-0987-05 Safeway 5 patches — — FDA listed —
Kroger Hot and Cold Medicated Patch 5 g/100g 30142-0979-05 Kroger 5 pouches — — FDA listed —
Topcare Cold and Hot Medicated 50 mg 36800-0860-05 Topco 5 patches — — FDA listed —
Icy Hot Back and Large Areas 5 g/100g 41167-0073-08 Chattem, 10 patches — — FDA listed —
Icy Hot Back and Large Areas 5 g/100g 41167-0083-02 Chattem, 1 patch — — FDA listed —
Icy Hot Arm Neck Leg and Small Areas 5 g/100g 41167-0084-01 Chattem, 5 patches — — FDA listed —
Icy Hot Back and Large Areas 5 g/100g 41167-0843-01 Chattem, 5 patches — — FDA listed —
Icy Hot XL Back and Large Areas 5 g/100g 41167-0847-01 Chattem, 3 patches — — FDA listed —
ICY Hot Value Pack 41167-0854-00 Chattem, 5 patches — — FDA listed —
Meijer Small Cold-Hot Medicated Patches 5 g 41250-0522-05 Meijer 5 patches — — FDA listed —
Meijer Large Cold-Hot Medicated Patches 5 g 41250-0834-05 Meijer 5 patches — — FDA listed —
Equate Menthol Pain Relieving 50 mg 49035-0870-01 Wal-Mart 1 patch — — FDA listed —
Equate Cool and Heat Extra Strength 50 mg 49035-0888-30 Wal-Mart 5 patches — — FDA listed —
Good Sense Hot and Cold Medicated Patch 5 g/100g 50804-0124-13 GOOD 5 pouches — — FDA listed —
Goodsense Extra Strength Cold and Hot Medicated 50 mg 50804-0126-05 Geiss, 5 patches — — FDA listed —
CVS Cooling Patch .5 g/10g 51316-0796-02 CVS 2 patches — — FDA listed —
CVS Health Cooling Patch 5 g/100g 51316-0976-10 CVS 10 patches — — FDA listed —
Cold And Hot Medicated Large .05 g/g 52000-0421-41 Universal 1 patch — — FDA listed —
Cold And Hot Medicated .05 g/g 52000-0422-41 Universal 2 patches — — FDA listed —
Medline 5 mg/100mg 53329-0972-05 Medline 5 patches — — FDA listed —
Menthol Pain Relief Gel Patch 50 mg 55629-0025-15 ONE2ZEE 15 patches — — FDA listed —
Dollar General Cold-Hot Medicated Patches 5 g/100g 55910-0903-01 DOLGENCORP, 1 pouch — — FDA listed —
Dollar General Cold Therapy Pain Relief 5 g/100g 55910-0949-01 Dolgencorp, 1 g — — FDA listed —
Dollar General Cold-Hot Medicated Patches 5 g 55910-0972-06 DOLGENCORP, 6 patches — — FDA listed —
Biofreeze Overnight Relief .3 g/6g 59316-0005-03 Reckitt 1 patch — — FDA listed —
Biofreeze Day and Overnight 59316-0832-94 Reckitt 1 patch — — FDA listed —
Biofreeze Menthol 59316-0887-04 Reckitt 1 patch — — FDA listed —
Biofreeze Menthol .05 g/g 59316-0992-07 Reckitt 1 patch — — FDA listed —
Icy Hot Medicated 205.5 mg 62168-0084-03 Lead 1350 patches — — Discontinued —
Icy Hot Medicated, XL 750 mg 62168-0847-04 Lead 400 patches — — FDA listed —
Icy Hot Medicated, Back 428.5 mg 62168-0853-01 Lead 500 patches — — FDA listed —
Winco Cold and Hot Medicated Patch Large 50 mg 67091-0914-05 WINCO 5 patches — — FDA listed —
Hot/Cold Medicated Patch 285 mg/5700mg 67777-0201-10 Dynarex 900 patches — — FDA listed —
Absorbine Jr 5000 mg/h 69693-0412-01 Clarion 1 patch — — FDA listed —
Icequake Coldn Hot medicated patch 50 mg/g 69822-0014-04 Southern 4 patches — — FDA listed —
CVS Cold and Hot 50 mg 69842-0243-05 CVS 5 patches — — FDA listed —
CVS Cold and Hot 50 mg 69842-0245-05 CVS 5 patches — — FDA listed —
Bengay Ultra Strength Large Size 50 mgthis 69968-0487-01 Kenvue 1 patch — — Discontinued —
HealthWise Medicated Cold Hot 5% Patch 5 g 71101-0031-06 Veridian 6 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 71101-0060-05 Veridian 5 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 71101-0061-05 Veridian 5 patches — — FDA listed —
HealthWise Medicated Cold Hot 5% 5 g 71101-0084-15 Veridian 15 patches — — FDA listed —
HealthWise Overnight Menthol Patch 5 g 71101-0085-12 Veridian 12 patches — — FDA listed —
TheraCare Pain Relief 5 g/100g 71101-0126-01 Veridian 4 patches — — FDA listed —
Thera Care Pain Relief Menthol Patchs 5 g/100g 71101-0913-05 Veridian 5 pouches — — FDA listed —
Theracare Cold Therapy Pain Relief 5 g 71101-0949-01 Veridian 5 patches — — FDA listed —
HealthWise Cold Therapy Pain Relief Patch 5 g/100g 71101-0950-15 Veridian 15 patches — — FDA listed —
Hot and Cold Medicated Patch 5 g/100g 71101-0952-15 Veridian 15 pouches — — FDA listed —
Thera Care Hot and Cold Medicated Patch 5 g/100g 71101-0953-05 Veridian 5 pouches — — FDA listed —
Thera Care Cold Hot Medicated Patch 5 g/100g 71101-0954-05 Veridian 5 pouches — — FDA listed —
Dr Sabharwals 240 mg 71318-0116-15 Dr. 15 patches — — FDA listed —
Menthol 5% 440 mg 71391-0123-18 Unexo 18 patches — — Discontinued —
Menthol 5% Hydrogel 600 mg 71391-0127-05 Unexo 5 patches — — Discontinued —
Cold Hot Medicated Patch 5% Menthol 5 g 71811-0005-05 InterMed 5 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 71811-0006-05 InterMed 5 patches — — FDA listed —
Hot and Cold Medicated Patch 5 g/100g 72036-0952-05 Harris 5 pouches — — FDA listed —
Amazon Basics Cold and Hot Medicated Patch 5 g/100g 72288-0966-15 Amazon.com 15 patches — — FDA listed —
Cycle 5 g/100g 72587-0001-02 La 1 patch — — FDA listed —
Relief 5 g/100g 72587-0003-01 La 4 patches — — FDA listed —
Hempvana Cold As Ice Pain Relief Gel-Patch 5 g/100g 73287-0005-01 Telebrands 7 patches — — FDA listed —
MENTHOL PAIN RELIEF Gel-Patch .05 g/g 73557-0131-15 Shanghai 15 patches — — Discontinued —
OVERNIGHT RELIEF Gel-Patch .05 g/g 73557-0133-05 Shanghai 5 patches — — FDA listed —
Pain Relief .05 g/g 73557-0192-05 Shanghai 5 patches — — FDA listed —
BonicaEaseX 24 Hour Menthol Pain Relieving 50 mg/g 75568-0045-00 Planet 15 patches — — FDA listed —
Topcare Pain Relief Patch 5 g/100g 76162-0999-05 76162 5 patches — — FDA listed —
Meijer Cold Therapy Pain Relieving 5 g/100g 79481-9966-05 Meijer 1 g — — FDA listed —
Menthol 5% 500 mg/10g 80425-0543-01 Advanced 30 patches — — FDA listed —
Cold Hot Medicated Patch 5% Menthol 5 g 83324-0256-05 Quality 5 patches — — FDA listed —
Hot Cold Medicated Patches 5 g/1001 83559-0003-01 Henan 2 patches — — FDA listed —
COLD AND HOT MEDICATED Patch 5 g/1001 83559-0014-01 Henan 48 patches — — FDA listed —
COLD AND HOT MEDICATED Patch 5 g/1001 83559-0015-01 Henan 24 patches — — FDA listed —
Rapid Relief 5 g/100g 83569-0012-05 RAPID 1 pouch — — FDA listed —
Menthol Pain Relief Gel-Patch .05 g/g 83602-0132-15 Guangzhou 15 patches — — FDA listed —
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patch .05 g/g 84165-0004-01 Guangzhou 12 g — — FDA listed —
AVCOO Menthol Pain Relief Patch 500 mg 84992-0004-01 ADP 1 patch — — FDA listed —
Menthol 5% 500 mg/10g 85096-0301-30 Marcella 30 patches — — FDA listed —
5% Menthol Pain Relief Patch 5 g/100g 85323-0004-00 Xuzhou 5 patches — — FDA listed —
5% Menthol Pain Relief Patch 5 g/100g 85323-0006-01 Xuzhou 48 patches — — FDA listed —
5% Menthol Pain Relief Patch 5 g/100g 85323-0007-01 Xuzhou 24 patches — — 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerKenvue Brands LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio567 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

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

⏱️ Dosage and Administration 53 words ▾

Directions open pouch and remove patch if desired, cut patch to size peel off protective backing and apply sticky side to affected area 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 106 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 the 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 4 words ▾

Active ingredient Menthol 5%

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients calcined kaolin, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, polyacrylic acid, polysorbate 80, propylparaben, silica, sodium polyacrylate, sodium polyacrylate starch, sorbitan oleate, sorbitol, tartaric acid, titanium dioxide, water

🎯 Purpose 3 words ▾

Purpose Topical analgesic

📄 Do Not Use 23 words ▾

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 13 words ▾

Ask a doctor before use if you have redness over the affected area

📄 When Using This Product 15 words ▾

When using this product avoid contact with eyes or mucous membranes do not bandage tightly

📄 Stop Use and Ask a Doctor If 31 words ▾

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 19 words ▾

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

📄 Questions or Comments 7 words ▾

Questions? call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 56 words ▾

PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton ULTRA STRENGTH MENTHOL 5% TOPICAL ANALGESIC PATCH BENGAY ® PAIN RELIEVING PATCH Targeted relief that's designed to stay in place 4 INDIVIDUALLY SEALED PATCH

3.9 IN x

7.9IN (10 cm x 20 cm) 4 LARGE FOR BACK TO HIP PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton

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 Bengay Ultra Strength Large Size (this brand).

Top reported reactions

Application Site Burn13
Application Site Erythema10
Application Site Vesicles5
Blister5
Application Site Pain4
Death4
Product Quality Issue4

Age at onset

Adult3

Reporter sex

0 reports

Serious outcomes

Hospitalization4
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5 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 No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 4 patches (69968-0487-04). 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.
← 69968-0483-03 · Kenvue 69968-0488-07 · Kenvue →
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.