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DermacinRx Penetral Cream Capsaicin .25 mg/mL Cream, 237 mL — NDC 59088-0310-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DermacinRx Penetral Cream Capsaicin .25 mg/mL Cream, 237 mL — NDC 59088-310-16 (Billing 59088-0310-16)

by PureTek Corporation · 237 mL in 1 BOTTLE, PUMP

This is a package of 237 mL of DermacinRx Penetral Cream Capsaicin .25 mg/mL Cream from PureTek Corporation, marketed since Jun 2015 and currently FDA-listed.

NDC 59088-0310-16
🏷️ FDA NDC (as labeled) 59088-310-16 billing pads the product segment with a zero
This package
Contains237 mL Pack sizes2 compare ↓
Product page 59088-0310-08 Also comes in: 118 ml 59088-310-08
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

NDC database record

One package, one record: these facts belong to NDC 59088-310-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59088 labeler · 310 product · 16 package
Package marketed since
Jun 9, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
237 mL per package
Barcode (UPC)
0359088310083
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59088-310-16
Product NDC 59088-310
11-digit billing NDC 59088031016
NCPDP billing unit ML — per mL (volume)
RxCUI 198555
UNII UW86K581WY
UPC 0359088310083
Application # M017
SPL Set ID 1e343a52-6071-3230-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-06-09
Route TOPICAL
Dosage form CREAM
Substance CAPSICUM OLEORESIN

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

GPI-14 90850025003710
GPI class DermacinRx Penetral
GCN Seq No 081319
GCN 48385
HICL code 007968
Ingredient (HICL) Capsicum Oleoresin
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name DERMACINRX PENETRAL 0.025% CRM
FDB brand name Dermacinrx Penetral
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 081319
  • GCN: 48385
  • GPI-14 (Medi-Span): 90850025003710
  • HICL (First Databank): 007968
  • AHFS class code: 84:92.00.00
  • RxCUI (RxNorm): 198555
Why two NDCs? The FDA registers this code as 59088-310-16 — 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 → 59088-0310-16. 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 Capsaicin and similar agents class.

Drug family (ATC) Capsaicin and similar agents, Other local anesthetics
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

Label name DERMACINRX PENETRAL 0.025% CRM Ingredient Capsicum Oleoresin
📖 What it is MedlinePlus · NLM

Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, completely normal — and it actually means the medicine is working. Capsaicin activates the same pain-sensing receptors in your skin that respond to heat and spicy food. That b...
  • Why does capsaicin burn when I put it on? Is that normal?
  • For most OTC creams and ointments, you can apply up to 3 to 4 times a day. For OTC patches, apply to clean, dry skin and remove after no more than 8 hours — again, up to 3 to 4 tim...
  • How often should I apply capsaicin cream or use the patch?
📖 Read our full Capsaicin guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Capsaicin (prescription drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Capsaicin (prescription drug) (3 interactions) — ranked by severity →
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 gPer 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: 118 ml
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
59088-0310-08 59088-310-08 Main listing 118 mL in 1 BOTTLE, PUMP 2021-10-25 — Active
59088-0310-16 You're viewing this 237 mL in 1 BOTTLE, PUMP 2015-06-09 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 237 mL — 237 ml in 1 bottle, pump.
How does this package differ from NDC 59088-0310-08?
Both are DermacinRx Penetral Cream Capsaicin .25 mg/mL Cream — the drug itself is identical. This page's package is the 237 mL one, while NDC 59088-0310-08 is the 118 ml package.
What NDC number is used to bill for this package of DermacinRx Penetral Cream Capsaicin .25 mg/mL Cream?
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
Capsaicin .25 mg/g 00536-2525-25 Rugby 1 tube $0.082 — Availability likely —
Capsaicin External Analgesic .25 mg/g 50268-0195-60 AvPAK 1 tube $0.082 — Availability likely —
Sheffield Arthritis and Muscle Pain Relief .25 mg/g 11527-0089-54 Sheffield 1 tube — — FDA listed —
Capsaicin .025 g/100g 50488-1025-01 Alexso, 1 tube — — FDA listed —
CareALL Arthritis and Muscle .025 g/g 51824-0094-15 New 42.5 g — — FDA listed —
Capsaicin 0.025% Cream .025 mg/g 59088-0220-08 Puretek 120 g — — FDA listed —
DermacinRx Penetral Cream .25 mg/mLthis 59088-0310-16 PureTek 237 ml — — FDA listed —
Penetrex(r) Arthritis Pain Relief .025 g/100g 62742-4216-02 Allure 1 tube — — FDA listed —
Rugby Capsaicin External Analgesic .25 mg/g 63187-0660-60 Proficient 1 tube — — FDA listed —
Capsaicin External Analgesic .25 mg/g 68071-3430-02 NuCare 1 tube — — FDA listed —
Capsaicin .025 g/100g 69420-6025-01 SA3, 120 g — — FDA listed —
Melt Pain Away .025 g/100g 72683-0003-01 Proximity 200 g — — FDA listed —
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS .025 g/100g 80489-0099-01 OL 1 tube — — FDA listed —
Thera Plus Pain Relief Arthritis and Muscle .25 mg/g 80684-0138-00 FOURSTAR 42.5 g — — FDA listed —
BRONSON SOOTHE Pain Relief .25 mg/mL 83158-0387-02 BRONSON 59 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Jun 2015
📍
2026
Currently FDA-listed
11 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Z0W6766A2W
    Acai oil is a plant-derived oil extracted from acai berries. In medicines, it serves as an emollient and carrier oil to help dissolve or distribute active ingredients and improve product texture and absorption.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 4XO4QFV777
    A branched starch polymer derived from plant sources. It acts as a binder to hold tablet ingredients together and as a filler to add bulk and structure to solid dosage forms.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII 6S7S02945H
    A synthetic compound derived from menthol, ethyl menthane carboxamide is used as a flavoring agent and sensory enhancer in medicines to improve taste and provide a cooling or soothing sensation.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII 9CO8OUL4TH
    A synthetic conditioning agent derived from behenic acid, a long-chain fatty substance. It helps soften hair and reduce static in shampoos and conditioners by coating the hair shaft.
  • UNII GPW77G0937
    Lauryl laurate is a synthetic oily compound made from lauric acid and lauryl alcohol. It acts as an emollient and lubricant in medicines, helping to soften formulations and reduce friction during manufacturing and use.
  • UNII 84XB4DV00W
    Linseed oil is a plant-based oil extracted from flax seeds. It's used in medicines as an emollient and lubricant to improve texture and help with ingredient mixing in formulations.
  • UNII 2BF9E65L7I
    A chemical compound combining menthol with lactic acid. It's used in medicines as a flavoring agent and to provide a cooling or soothing sensation on the skin or mouth.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII 6QOP5A9489
    A synthetic organic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and improve their absorption through the skin.
  • UNII 4YWS14FAXH
    A chemical compound derived from starch that acts as a thickener and stabilizer. It helps keep ingredients evenly mixed and improves the texture and shelf life of the medicine.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 34N07GUJ3X
    A synthetic conditioning agent derived from coconut oil. It functions as an emulsifier and thickener, helping blend water and oil-based ingredients together and improving the texture and feel of the formulation.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

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

The official label also statesAcrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Euterpe Oleracea (Acai) Fruit Oil, Glycerin,Hydrated Silica, Hydrolyzed Corn Starch, Hydrolyzed Corn Starch Octenylsuccinate, Lauryl Laurate, Linum Usitatissimum (Linseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine, Zea Mays (Corn) Starch.

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

LabelerPureTek Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedJun 2015
Product typeHuman Otc 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.

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 📄 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 22 words ▾

Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

⏱️ Dosage and Administration 78 words ▾

Directions Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock. Before using on children under 18 years of age, consult a physician. Apply sparingly to affected area not more than 4 times daily.

However, for first use, apply to small area to test for sensitivity or skin reaction. Gently massage into the skin until fully absorbed. Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

⚠️ Warnings ~1 min read ▾

Warnings For external use only This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise.

Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, 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. If inhaled, remove to fresh air.

If breathing is difficult, get medical attention immediately.

📦 Storage and Handling 22 words ▾

Other information WARNING: FLAMMABLE PRODUCT Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

🧪 Active Ingredient 11 words ▾

Active ingredient Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%) Purpose Topical Analgesic

🧪 Inactive Ingredients 69 words ▾

Inactive ingredients Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Euterpe Oleracea (Acai) Fruit Oil, Glycerin,Hydrated Silica, Hydrolyzed Corn Starch, Hydrolyzed Corn Starch Octenylsuccinate, Lauryl Laurate, Linum Usitatissimum (Linseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine, Zea Mays (Corn) Starch.

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

📄 Do Not Use 101 words ▾

This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise.

Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

📄 When Using This Product 36 words ▾

When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

📄 Stop Use and Ask a Doctor If 69 words ▾

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

📄 Keep Out of Reach of Children 35 words ▾

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

📄 Questions or Comments 11 words ▾

Questions or comments? Call toll-free 1-877-921-7873 or visit us at www.dermacinrx.com

📄 Package Label / Principal Display Panel 6 words ▾

DermacinRx ® Penetral™ Cream Label Label

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
118 ml59088-0310-08 53 Rx · $52,147
237 ml this page59088-0310-16 No Medicaid data
Drug total (last 4 qtrs): 53 Rx · 6,844 units · $52,147 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 DermacinRx Penetral Cream (this brand).

Top reported reactions

Fatigue141
Weight Increased99
Pain91
Insomnia89
Poor Quality Sleep75
Hypertension71
Cataract68

Reporter sex

1,399 reports
Male · 43%
Female · 56%
Unknown · 0%

Serious outcomes

Death73
Life-threatening56
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 124 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PureTek Corporation. 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 118 ml (59088-0310-08). 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?
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 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.
← 59088-0308-03 · PureTek 59088-0315-16 · 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.