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in the FDA label

Xrylix Diclofenac Sodium Kit — NDC 59088-365-00 (Billing 59088-0365-00)

by PureTek Corporation · 1 KIT in 1 PACKAGE * 1 BOTTLE in 1 CARTON / 150 mL in 1 BOTTLE

This is a package of Xrylix Diclofenac Sodium Kit from PureTek Corporation, no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 59088-0365-00
🏷️ FDA NDC (as labeled) 59088-365-00 billing pads the product segment with a zero
Rx only Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Mar 13, 2024 · 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 59088-365-00 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59088 labeler · 365 product · 00 package
Barcode (UPC-A, from the NDC)
3 5908836500 7
FDA record last changed
Mar 13, 2024
⚠️
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 27, 2026 — Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0342-2026
Class III · Dec 22, 2025 — Failed PH Specifications (Cipla USA, Inc.) · FDA recall D-0291-2026
Class II · Jun 22, 2023 — Defective Delivery System (ALEMBIC PHARMACEUTICALS, INC.) · FDA recall D-0941-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2024. 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) 59088-365-00
Product NDC 59088-365
11-digit billing NDC 59088036500
NCPDP billing unit EA — each (per item)
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Apr 2024)
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 075811
GCN 40952
HICL code 043239
Ingredient (HICL) Diclofenac/Kinesiology Tape
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5E
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory, Nsaids
AHFS code 28:08.04.92
AHFS class Nonsteroidal Anti-Inflamm. Agents, Misc
FDB label name XRYLIX 1.5% KIT
FDB brand name Xrylix
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075811
  • GCN: 40952
  • HICL (First Databank): 043239
  • AHFS class code: 28:08.04.92
Why two NDCs? The FDA registers this code as 59088-365-00 — 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 → 59088-0365-00. 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

Label name XRYLIX 1.5% KIT Ingredient Diclofenac/Kinesiology Tape
📖 What it is MedlinePlus · NLM

Nonprescription (over-the-counter) diclofenac topical gel (Voltaren Arthritis Pain) is used to relieve pain from arthritis in certain joints such as those of the knees, ankles, feet, elbows, wrists, and hands. Prescription diclofenac topical solution (Pennsaid) is used to relieve osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain. Diclofenac is also available as a 3% gel (Solaraze; generic) that is applied to the skin to treat actinic keratosis...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your produ...
  • Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb,...
  • Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your docto...
  • Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new ra...
📖 Read our full Diclofenac guide →
1
Nutrient depletion considerations

Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diclofenac Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
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
59088-0365-00 You're viewing this Main listing 1 KIT in 1 PACKAGE * 1 BOTTLE in 1 CARTON / 150 mL in 1 BOTTLE 2017-03-01 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diclofenac Sodium 16.05 mg/mL 51672-1358-02 Sun 1 bottle $0.129 AT Availability likely —
Diclofenac Sodium 16.05 mg/mL 65162-0911-74 Amneal 1 bottle $0.129 AT Availability likely —
Diclofenac Sodium 1.5% 16.05 mg/mL 70512-0038-05 SOLA 1 bottle $0.129 AT Availability likely —
Diclofenac Sodium 16.05 mg/mL 70512-0810-05 SOLA 1 bottle $0.129 AT Availability likely —
Diclofenac Sodium 16.05 mg/mL 40032-0016-61 Novel 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 50090-3316-00 A-S 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 50090-6713-00 A-S 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 55700-0591-15 Quality 1 bottle — — FDA listed —
Lixofen 59088-0804-00 PureTek 1 kit — — FDA listed —
Diclofenac Sodium 16.05 mg/mL 63187-0791-15 Proficient 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 68788-7270-01 Preferred 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 68788-7715-01 Preferred 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 70518-2811-00 REMEDYREPACK 1 bottle — AT FDA listed —
Diclofenac sodium 16.05 mg/mL 71205-0062-15 Proficient 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 71205-0450-15 Proficient 1 bottle — — FDA listed —
Diclofenac Sodium 16.05 mg/mL 71205-0579-15 Proficient 1 bottle — AT FDA listed —
Diclofenac Sodium 1.5% 16.05 mg/mL 71205-0640-15 Proficient 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 71205-0811-15 Proficient 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 72162-2031-02 Bryant 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 72189-0075-05 DIRECT 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 72189-0273-05 DIRECT 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 72189-0319-05 DirectRx 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 72189-0454-05 Direct_Rx 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 72189-0527-05 Direct_Rx 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 76420-0012-30 Asclemed 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 76420-0134-05 Asclemed 150 ml — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 76420-0919-02 Asclemed 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 80425-0237-01 Advanced 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 80425-0240-01 Advanced 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 80425-0361-01 Advanced 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 80425-0368-01 Advanced 1 bottle — AT FDA listed —
Diclofenac Sodium 1.5% 16.05 mg/mL 85509-1038-01 PHOENIX 1 bottle — AT FDA listed —
Diclofenac Sodium 16.05 mg/mL 85509-1911-01 PHOENIX 1 bottle — AT FDA listed —
berkley and jensen arthritis pain 68391-0205-00 BJWC 1 kit — — FDA listed —
Voltaren Arthritis Pain 00067-8153-01 Haleon 1 kit — — FDA listed —
Diclofenac Sodium 58602-0606-21 Aurohealth 1 kit — — FDA listed —
Voltaren Arthritis Pain 00067-8154-01 Haleon 1 kit — — FDA listed —
Xrylixthis 59088-0365-00 PureTek 1 kit — — Discontinued —
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
Currently FDA-listed
listed with the FDA
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerPureTek Corporation
Labeler code59088
Product typeHuman Prescription Drug
Portfolio178 products on file

More NDCs from PureTek Corporation labeler code 59088

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diclofenac Sodium (matched by generic name) — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diclofenac Sodium. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$30M
Claims incl. refills
804.1K
Beneficiaries
539.2K
Spend / beneficiary
$55.63
Spend / claim
$37.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
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 "Unapproved Drug Other". 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.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
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.
Who lists this product with the FDA?
PureTek Corporation 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 59088-0350-03 · PureTek 59088-0371-07 · PureTek →
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.