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VAZALORE Aspirin 81 mg/81mg Capsule — NDC 73089-0081-21 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

VAZALORE Aspirin 81 mg/81mg Capsule — NDC 73089-081-21 (Billing 73089-0081-21)

by PLx Pharma Inc · 1 BOTTLE, PLASTIC in 1 CARTON / 81 mg in 1 BOTTLE, PLASTIC

This is a package of VAZALORE Aspirin 81 mg/81mg Capsule from PLx Pharma Inc, no longer marketed, no longer in the FDA NDC Directory.

NDC 73089-0081-21
🏷️ FDA NDC (as labeled) 73089-081-21 billing pads the product segment with a zero
This package
Contains81 mg in 1 bottle, plastic Pack sizes3 compare ↓
Product page 73089-0081-12 Also comes in: 81 mg 73089-081-12 81 mg 73089-081-14
OTC Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 16, 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 73089-081-21 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
73089 labeler · 081 product · 21 package
Barcode (UPC-A, from the NDC)
3 7308908121 6
FDA record last changed
Jul 16, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. 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) 73089-081-21
Product NDC 73089-081
11-digit billing NDC 73089008121
NCPDP billing unit EA — each (per item)
Application # NDA203697
SPL Set ID c6d08008-2ac1-ab6e-e053-2a95a90a8aa2
Established class (EPC) Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2025)
Route ORAL
Dosage form CAPSULE
Substance ASPIRIN

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

GCN Seq No 082518
GCN 49959
HICL code 001820
Ingredient (HICL) Aspirin
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9P
Therapeutic class — specific (HIC3) Platelet Aggregation Inhibitors
AHFS code 20:12.18.00
AHFS class Platelet-Aggregation Inhibitors
FDB label name VAZALORE 81 MG CAPSULE
FDB brand name Vazalore
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 082518
  • GCN: 49959
  • HICL (First Databank): 001820
  • AHFS class code: 20:12.18.00
Why two NDCs? The FDA registers this code as 73089-081-21 — 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 → 73089-0081-21. 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 VAZALORE 81 MG CAPSULE Ingredient Aspirin
📖 What it is MedlinePlus · NLM

Aspirin is used to: reduce fever relieve mild to moderate pain and inflammation prevent heart attacks, strokes or mini-strokes reduce the risk of death in people who are experiencing or who have had a heart attack Aspirin is in a group of medications called salicylates. It works by blocking natural substances that cause fever, pain, swelling, and blood clots. Aspirin is also available in combination with other medications such as pain relievers and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product,...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Aspirin is used to temporarily relieve common minor pains — things like headaches, backaches, muscle aches, toothaches, menstrual cramps, and discomfort from a cold — and to reduce...
  • Generally, no — aspirin should not be given to children under 12. More importantly, children and teenagers who have or are recovering from chickenpox or a flu-like illness should n...
  • Yes, stomach upset, heartburn, and nausea are real possibilities with aspirin. Taking it with a full glass of water helps. Some people tolerate enteric-coated or delayed-release fo...
  • Does aspirin upset your stomach? What can I do about it?
📖 Read our full Aspirin guide →
3
Nutrient depletion considerations

Aspirin may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aspirin 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.
Try another pack size: 81 mg 81 mg
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
73089-0081-12 73089-081-12 Main listing 1 BLISTER PACK in 1 CARTON / 81 mg in 1 BLISTER PACK 2021-08-05 — Inactivated by FDA
73089-0081-14 73089-081-14 81 mg in 1 CARTON 2021-08-05 — Inactivated by FDA
73089-0081-21 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 81 mg in 1 BOTTLE, PLASTIC 2021-08-05 — Inactivated by FDA

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 carton / 81 mg in 1 bottle, plastic.
What NDC number is used to bill for this package of VAZALORE Aspirin 81 mg/81mg Capsule?
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
Vazalore 81 mg/81mgthis 73089-0081-21 PLx 1 bottle — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2013
First FDA approval
Jan 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 14, 2013 RLD RS ⏳ ~6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

When could a generic Vazalore arrive?

Our estimate: September 2032 about 6 years away

How sure: Toss-up. Still unsettled. Just as likely to slip as to hold.

Why then: A patent that protects the brand runs out. After that, approved generics can be sold.

See the full forecast for generic Vazalore →
Patents & exclusivity — FDA Orange Book
US 9226892 — method of use (U-1733)
US 9226892 — method of use (U-1731)
US 9226892 — method of use (U-1732)
US 10786444 — method of use (U-3559)
US 10786444 — method of use (U-3559)
US 10646431 — drug product
US 10646431 — drug product
US 9216150 — drug product
2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Expected generic
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (8)
PatentTypeUse codeExpires
US 9226892 ↗ Method of use U-1733 Sep 29, 2032
US 9226892 ↗ Method of use U-1731 Sep 29, 2032
US 9226892 ↗ Method of use U-1732 Sep 29, 2032
US 10786444 ↗ Method of use U-3559 Sep 29, 2032
US 10786444 ↗ Method of use U-3559 Sep 29, 2032
US 10646431 ↗ Drug product — Sep 29, 2032
US 10646431 ↗ Drug product — Sep 29, 2032
US 9216150 ↗ Drug product — Sep 29, 2032
Common questions
Is there a generic version of VAZALORE 81 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VAZALORE 81 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2032 — an estimate, not a guaranteed launch date. We expect the first generic Vazalore in September 2032, about 6 years away. See the forecast.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

Color white
ShapeCapsule
ImprintA81
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Aspirin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 2UMI9U37CP
    Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesInactive ingredients Anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean oil, titanium dioxide

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

LabelerPLx Pharma Inc
Application holderPLX PHARMA INC
FDA applicationNDA203697 (NDA)
Labeler code73089
Product typeHuman Otc Drug
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 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

Uses For temporary relief of minor aches and pains associated with: headache Backache muscular aches a cold toothache minor pains of arthritis premenstrual and menstrual cramps temporarily redices fever n ask your doctor about other uses of aspirin capsules

⏱️ Dosage and Administration 50 words ▾

Directions Directions Drink a full glass of water with each dose Adults and children 12 years and over: Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist Do not exceed 12 capsules in 24 hours Children under 12 years consult a doctor

⚠️ Warnings 153 words ▾

Warnings Warnings Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include n hives n facial wseelling n shock n astham (wheezing) This product contains soy Stomach bleeding warning: This product contains an NSAID, which may cause bleeding.

The chance is higher if you: Are age 60 or older Have had stomach ulcers or bleeding problems Take a blood thinning (anticoagulant) or steroid drug Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) Have 3 or more alcoholic drinks every day while using this product Take more or for a longer time than directed

📦 Storage and Handling 35 words ▾

Other Information Other Information Save carton for full directions and warnings Store at 15-30°C (59-86°F) Avoid excessive heat above 40°C (104°F) Do not use if the blue band around the capsule is missing or broken

🧪 Active Ingredient 13 words ▾

Active Ingredient (in Each capsules) Aspirin (NSAID)* 325mg *Non steroidal Anti inflammatory Drug

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients Anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean oil, titanium dioxide

🎯 Purpose 15 words ▾

Purposes: Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer *Non steroidal Anti inflammatory Drug

📄 Do Not Use 21 words ▾

Do not use If you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer

📄 Ask a Doctor Before Use If 42 words ▾

Ask a doctor before use if: Stomach bleeding warning applies to you You have a history of stomach problems, such as heartburn You have high blood pressure, heart disease, liver cirrhosis, or kidney disease You are taking a diuretic You have asthma

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or a pharmacist before you use if you are Taking a drug for diabetes, gout or arthritis

📄 Stop Use and Ask a Doctor If 100 words ▾

Stop use and ask a doctor Stop use and ask a doctor if An allergic reaction occurs. Seek medical help right away You experience amu of the following signs of stomach bleeding - Feel faint - vomit blood - have bloody or black stool - have stomach pain that does not get better Pain gets worse or lasts more than 10 days Fever gets worse or lasts more than 3 days Ringing in the ears or loss of hearing occurs Redness and swelling is present in the painful area Any new symptoms occur. These could be signs of serious conditions

🤰 If Pregnant or Breast-Feeding 49 words ▾

If pregnant or breast feeding , ask a healthcare professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

📄 Questions or Comments 24 words ▾

Questions or Comments Questions or comments? Call 1-888-842-3569 9:00 AM – 7:00 PM ET, Monday – Friday RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION

📄 Package Label / Principal Display Panel 40 words ▾

30 Count Blister Carton 30 CT Bottle Carton

30 Count Bottle Label 30 CT Bottle Label

4 Count Blister Card 4 ct blister card

4 Count Blister Carton 4 Ct Blister Carton

12 Count Blister Carton 12 Ct Blister Carton

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 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) ✓ 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 ✓ Available
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

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 2 other package presentations of this same product, including 81 mg (73089-0081-12), 81 mg (73089-0081-14). 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?
PLx Pharma Inc 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.
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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.