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Biofreeze Ultraflex Plus Lidocaine, Menthol .04 g/g; .01 g/g Patch — NDC 59316-0898-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Biofreeze Ultraflex Plus Lidocaine, Menthol .04 g/g; .01 g/g Patch — NDC 59316-898-04 (Billing 59316-0898-04)

by Reckitt Benckiser LLC · 4 PATCH in 1 CARTON / 2 g in 1 PATCH

This is a package of Biofreeze Ultraflex Plus Lidocaine, Menthol .04 g/g; .01 g/g Patch from Reckitt Benckiser LLC, marketed since Jan 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 59316-0898-04
🏷️ FDA NDC (as labeled) 59316-898-04 billing pads the product segment with a zero
This package
Contains2 g in 1 patch Pack sizes2 compare ↓
Main listing for product 59316-898 · Also comes in: 2 g 59316-898-07
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59316-898-04
Product NDC 59316-898
11-digit billing NDC 59316089804
RxCUI 1249758
UNII 98PI200987, L7T10EIP3A
UPC 0731124445261
Application # M017
SPL Set ID 401e1843-e9a6-fda9-e063-6294a90a3073
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-31
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE; MENTHOL
Quick answers
  • RxCUI (RxNorm): 1249758
Why two NDCs? The FDA registers this code as 59316-898-04 — 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 → 59316-0898-04. 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.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Biofreeze Ultraflex Plus Lidocaine, Menthol is a topical patch containing lidocaine and menthol. Lidocaine is a local anesthetic commonly used to numb skin and underlying tissue where applied. Menthol produces a cooling sensation and is often included in topical products for temporary relief of minor aches and discomfort. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this category of pain-relief patches rather than as an individually approved product.

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: 2 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
59316-0898-04 You're viewing this Main listing 4 PATCH in 1 CARTON / 2 g in 1 PATCH 2026-01-31 — Active
59316-0898-07 59316-898-07 1 PATCH in 1 POUCH / 2 g in 1 PATCH 2026-01-31 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 patch in 1 carton / 2 g in 1 patch.
What NDC number is used to bill for this package of Biofreeze Ultraflex Plus Lidocaine, Menthol .04 g/g; .01 g/g 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
Lidocaine Menthol Pain Relief 4 g/100g; 1 g/100g 46122-0574-21 Amerisource 5 patches $0.952 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 70000-0558-01 Cardinal 5 patches $0.952 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 00363-0914-05 Walgreen 5 patches — — FDA listed —
Walgreens Cool N Heat Patch 10 mg/g; 40 mg/g 00363-6670-05 Walgreen 5 patches — — FDA listed —
Walgreens Kinesiology Pain Relief 4 mg/100mg; 1 mg/100mg 00363-9657-00 Walgreen 20 applicators — — FDA listed —
Maximum Strenght Lidocaine plus Menthol Pain Relief Patch 1 g/100g; 4 g/100g 11822-6514-01 Rite 5 patches — — FDA listed —
Albertson Lidocaine, Menthol Pain Relief Medicated Patch 4 g/100g; 1 g/100g 21130-0961-05 Safeway 5 g — — FDA listed —
Icy Hot with Lidocaine 240 mg/1; 60 mg 41167-1720-01 Chattem, 5 patches — — FDA listed —
Maximun Strength Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 41250-0841-05 Meijer 5 patches — — FDA listed —
CVS Cold and Hot Pain Relief 10 mg/g; 40 mg/g 51316-0274-05 CVS 5 patches — — FDA listed —
Lidospot patch .01 g/g; .04 g/g 51452-0172-05 Fabrication 5 patches — — FDA listed —
Point Relief LidoSpot with Menthol 4 g/100g; 1 g/100g 51452-0912-05 Fabrication 5 patches — — FDA listed —
MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100g 55301-0912-05 ARMY 5 patches — — FDA listed —
Biofreeze Ultraflex Plus .04 g/g; .01 g/gthis 59316-0898-04 Reckitt 4 patches — — FDA listed —
CVS Health Lidocaine Pain Relief Plus Menthol 240 mg/1; 60 mg 66902-0220-05 Natural 5 patches — — FDA listed —
Pure-Aid 240 mg/1; 60 mg 67510-0284-01 Kareway 1 patch — — FDA listed —
Soundbody 40 mg/1; 10 mg 67510-0636-01 Kareway 1 patch — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 68788-8879-01 Preferred 15 mg — — FDA listed —
Lidocaine Pain Relief Patch 1 g/100g; 4 g/100g 69159-0920-05 Foshan 5 patches — — FDA listed —
HealthWise Lidocaine Plus Menthol Patch 4 g/100g; 1 g/100g 71101-0062-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol 4 g/100g; 1 g/100g 71101-0082-15 Veridian 15 g — — FDA listed —
TheraCare 2X Medicated Pain Relief 1 g/100g; 4 g/100g 71101-0127-01 Veridian 5 patches — — FDA listed —
TheraCare Pain Relief Medicated 4 g/100g; 1 g/100g 71101-0912-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol Pain Relief 4 g/100g; 1 g/100g 71101-0914-05 Veridian 5 g — — FDA listed —
Lidozen 40 mg/g; 10 mg/g 71205-0348-05 Proficient 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71205-0745-05 Proficient 5 patches — — FDA listed —
Dr Sabharwals 224 mg/1; 56 mg 71318-0115-15 Dr. 15 patches — — FDA listed —
AsperFlex MAX 240 mg/1; 60 mg 71399-4453-05 Akron 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71574-0905-05 Village 5 patches — — FDA listed —
Hot and Cold Lidocaine with Menthol Patch Pain Relief 240 mg/1; 60 mg 71811-0002-05 InterMed 500 patches — — FDA listed —
Lidothol Patch 1 mg/100mg; 4 mg/100mg 72189-0553-15 Direct_Rx 1 patch — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0172-05 Shanghai 5 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0174-20 Shanghai 20 patches — — FDA listed —
Pain Relief .01 g/g; .04 g/g 73557-0175-20 Shanghai 20 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0176-18 Shanghai 18 patches — — FDA listed —
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee 40 mg/g; 10 mg/g 75568-0013-01 Planet 4.56 g — — FDA listed —
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border 40 mg/g; 10 mg/g 75568-0014-01 Planet 9.1 g — — FDA listed —
Careland Plantar Fasciitis Hydrogel Pain Patches 40 mg/g; 10 mg/g 75568-0017-01 Planet 8 pouches — — FDA listed —
Careland Hydrogel Pain Relief Patches 40 mg/g; 10 mg/g 75568-0022-01 Planet 8 patches — — FDA listed —
TopCare Pain Relief Patch 4 g/100g; 1 g/100g 76162-0007-05 Topco 5 pouches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 76420-0581-15 Asclemed 15 patches — — FDA listed —
Equate Lidocaine and Menthol Paraben Free 1 g/100g; 4 g/100g 79903-0030-05 Walmart 5 pouches — — FDA listed —
Equate Lidocaine Cool and Heat 1 g/100g; 4 g/100g 79903-0038-05 Walmart 5 pouches — — FDA listed —
Lidothol 1 mg/100mg; 4 mg/100mg 80425-0385-01 Advanced 15 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 80425-0506-01 Advanced 15 mg — — FDA listed —
Lidocaine and Menthol .04 g/g; .01 g/g 80425-0560-01 Advanced 30 patches — — FDA listed —
LidoPro .04 g/g; .01 g/g 80425-0582-01 Advanced 30 patches — — FDA listed —
LidoReal Patch 4 mg/1; 1 mg 81877-0725-15 FORREAL 15 patches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 81902-0104-15 Whitestone 15 patches — — FDA listed —
Lidosync 4 g/1; 1 g 82944-0104-10 Ion 10 patches — — FDA listed —
Pain Relief Gel-Patch .12 g/12g; .48 g/12g 83016-0171-07 R 7 packets — — FDA listed —
AUVON Lidocaine Menthol Pain Relief Patch 100 mg/1; 400 mg 83391-0008-01 SHENZHEN 1 patch — — FDA listed —
Collajoint Lidocaine Pain Relief Gel Patch 1 g/1001; 4 g/1001 83559-0012-01 Henan 12 patches — — FDA listed —
Rapid Relief 1 g/100g; 4 g/100g 83569-0014-01 RAPID 100 g — — FDA listed —
Rapid Relief 4 g/100g; 1 g/100g 83569-0016-06 RAPID 1 pouch — — FDA listed —
Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0172-15 Guangzhou 15 patches — — FDA listed —
Foot Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0174-15 Guangzhou 15 patches — — FDA listed —
Lidocaine Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0175-11 Guangzhou 11 patches — — FDA listed —
Knee Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0178-12 Guangzhou 12 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 83881-0402-05 Clinic 5 mg — — FDA listed —
LidoPro .04 g/g; .01 g/g 83881-0403-01 Clinic 1 patch — — FDA listed —
Lidothol 4 mg/100mg; 1 mg/100mg 83881-0441-15 Clinic 15 patches — — Discontinued —
Plantar Fasciitis Pain Relief Gel-Patch 1 g/100g; 4 g/100g 84165-0007-01 Guangzhou 6 g — — FDA listed —
Chinese Red Tiger Lidocaine Patches .04 g/g; .01 g/g 84165-0010-01 Guangzhou 12 g — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 84165-0104-01 Guangzhou 12 g — — FDA listed —
Perform Leo Extensive Pain Relief 4 g/100g; 1 g/100g 84410-0001-01 PERFORM 5 patches — — FDA listed —
Lidocaine .4 g/10g; .1 g/10g 84722-3041-00 Vive 5 g — — FDA listed —
Lidocaine .1 g/10g; .4 g/10g 84722-3072-00 Vive 5 g — — FDA listed —
4% lidocaine plus 1% menthol Pain Relief Patch 1 g/100g; 4 g/100g 85323-0003-00 Xuzhou 5 patches — — FDA listed —
4% Lidocaine Patches 4 g/100g; 1 g/100g 85593-0010-01 Guangzhou 15 patches — — Discontinued —
NeuroCool Patches 4 mg/100mg; 1 mg/100mg 85622-0500-15 Blue 15 pouches — — FDA listed —
Plantar Pain Relief Patch .01 g/g; .04 g/g 87518-0174-15 Guangzhou 15 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

🏛️
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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII XH62RP786N
    A sticky resin-based substance derived from rosin. It acts as a binder and thickener to help hold the medicine together and improve its texture and consistency.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII TQ77WR8A02
    A synthetic rubber polymer used as a binder and film-former in medicines. It helps hold tablet ingredients together and can create a protective coating or matrix that controls how quickly the drug releases in the body.
  • UNII K7S96QM8DV
    A synthetic rubber-like plastic made from linked chains of styrene and isoprene. It's used in medicines as a binder to hold ingredients together and as a film-former to create protective coatings on tablets or capsules.

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

The official label also statesInactive ingredients: Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene, Styrene/Isoprene/Styrene Block Copolymer

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

LabelerReckitt Benckiser LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code59316
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio174 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses For the temporary relief of pain

⏱️ Dosage and Administration 94 words ▾

Directions 􀂄 adults and children 12 years of age and older: Clean and dry affected area, cut open pouch and remove patch from protective film by first peeling back center film. Apply exposed patch to affected area. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours.

(see images on carton) 􀂄 use 1 patch at a time and not more than 3 to 4 times daily 􀂄 children under 12 years of age: consult a physician 􀂄 wash hands after use with cool water

⚠️ Warnings 214 words ▾

Warnings For external use only. Do not use 􀂄 more than 1 patch on your body at a time or with other topical anesthetics at the same time 􀂄 on wounds, damaged skin, rashes, or swollen skin 􀂄 with a heating pad or apply local heat to the area of use 􀂄 in large quantities, particularly over raw surfaces or blistered areas When using this product 􀂄 use only as directed 􀂄 do not bandage tightly 􀂄 avoid contact with the eyes or on mucous membranes 􀂄 dispose of used patch in manner that always keeps product away from children and pets.

Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if 􀂄 the condition for which this preparation is used persists or if a rash, redness or irritation develops 􀂄 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within few days 􀂄 you experience pain, swelling or blistering of the skin If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets .

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredient: Lidocaine 4% Menthol 1% Purpose: Pain Relieving Patch

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients: Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene, Styrene/Isoprene/Styrene Block Copolymer

🎯 Purpose 8 words ▾

Uses Uses For the temporary relief of pain

📄 Keep Out of Reach of Children 22 words ▾

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

📄 Other Information 18 words ▾

Other information 􀂄 store at 20-25°C (68-77°F) 􀂄 store in a cool dry place away from direct sunlight

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-682-4639

📄 Package Label / Principal Display Panel 3 words ▾

full carton label

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 Reckitt Benckiser 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 1 other package presentation of this same product, including 1 patch (59316-0898-07). 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?
Reckitt Benckiser 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.
← 59316-0887-04 · Reckitt 59316-0899-04 · RB →
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.