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Enteric Coated Aspirin Regular Strength 325 mg/3251 Tablet, Delayed Release, 100,000-count — NDC 49483-0331-00 package photo

Enteric Coated Aspirin Regular Strength 325 mg/3251 Tablet, Delayed Release, 100,000-count

by Time-Cap Labs, Inc · 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-331-00)
NDC 49483-0331-00
🏷️ FDA NDC (as labeled) 49483-331-00 billing pads the product segment with a zero
This package
Contains100,000-count Pack sizes3 compare ↓
Also comes in: 100 tablets 49483-0331-01 1000 tablets 49483-0331-10
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 49483-331-00
Product NDC 49483-331
11-digit billing NDC 49483033100
RxCUI 198467
UNII R16CO5Y76E
UPC 0349483331103
Application # M013
SPL Set ID 5fbd8bb3-46f9-4089-9a21-b6af97a06106
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-01-04
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance ASPIRIN
GPI-14 64100010000605
GPI class Aspirin EC
GCN Seq No 004381
GCN 16720
HICL code 001820
Ingredient (HICL) Aspirin
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3D
Therapeutic class — specific (HIC3) Analgesic/Antipyretics, Salicylates
AHFS code 20:12.18.00
AHFS class Platelet-Aggregation Inhibitors
FDB label name ASPIRIN EC 325 MG TABLET
FDB brand name Aspirin Ec
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 49483-331-00 — 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 → 49483-0331-00. 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.

🏷️ RxNorm drug class

This medicine belongs to the Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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.

🏭 Manufacturer & labeler

LabelerTime-Cap Labs, Inc
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code49483
First marketedJan 2011
Product typeHuman Otc Drug
Portfolio11 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.

🩺 Clinical

Label name ASPIRIN EC 325 MG TABLET 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.

💊 What it looks like

Color orange
ShapeRound
ImprintT
Size11 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.

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

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • 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 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 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesInactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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.

💲 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: 100 tablets 1000 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Enteric Aspirin 325 mg 63868-0898-10 CHAIN 100 tablets $0.019 — FDA listed —
Aspirin Regular Strength 325 mg 00536-1232-01 Rugby 100 tablets $0.022 — Availability likely —
Aspirin 325 mg 46122-0596-02 Amerisource 125 tablets $0.022 — Availability likely —
Regular Strength Aspirin 325 mg 70000-0014-01 CARDINAL 300 tablets $0.022 — Availability likely —
Aspirin Regular Strength 325 mg 70000-0035-01 Cardinal 125 tablets $0.022 — Availability likely —
Enteric Coated Aspirin 325 mg 70677-1122-01 STRATEGIC 125 tablets $0.022 — Availability likely —
Enteric Aspirin 325 mg 83324-0058-01 Chain 100 tablets $0.022 — Availability likely —
Bayer Aspirin Regimen enteric coated 325 mg 00280-2110-10 Bayer 100 tablets — — FDA listed —
Aspirin Enteric Coated, Regular Strength 325 mg 00363-0227-14 Walgreen 500 tablets — — FDA listed —
Aspirin 325 325 mg 00363-0691-12 Walgreen 100 tablets — — FDA listed —
Aspirin 325 mg 00363-6453-53 WALGREENS 500 tablets — — FDA listed —
aspirin pain relief 325 mg 11822-2270-04 Rite 500 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 11822-6910-01 Rite 100 tablets — — FDA listed —
Aspirin 325 mg 17714-0011-01 Advance 100 tablets — — FDA listed —
Regular Strength Enteric coated aspirin 325 mg 17856-0922-01 ATLANTIC 1 tablet — — FDA listed —
Enteric Coated Aspirin Regular Strength 325 mg 21130-0081-05 Safeway 500 tablets — — FDA listed —
Aspirin 325 mg 37808-0174-32 H-E-B 300 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 41163-0522-02 United 125 tablets — — FDA listed —
Enteric Coated Aspirin Regular Strength 325 mg/3251this 49483-0331-00 Time-Cap 100000 tablets — — FDA listed —
Aspirin 325 mg 51662-1494-01 HF 100 tablets — — FDA listed —
Enteric Coated Aspirin 325 mg 53943-0081-02 DISCOUNT 125 tablets — — FDA listed —
Aspirin 325 mg 54738-0111-01 Richmond 100 tablets — — FDA listed —
Regular Strength Enteric coated aspirin 325 mg 57896-0921-01 Geri-Care 100 tablets — — FDA listed —
Aspirin 325 mg 59779-0157-14 CVS 500 tablets — — FDA listed —
Regular Strength Enteric coated aspirin 325 mg 60760-0799-24 St. 24 tablets — — FDA listed —
Ecotrin Regular Strength 325 mg 63029-0302-01 Medtech 300 tablets — — FDA listed —
Enteric Coated Aspirin 325 mg 63941-0181-02 VALU 125 tablets — — FDA listed —
Aspirin 325 mg 67091-0110-10 WinCo 100 tablets — — Discontinued —
Aspirin 325 mg 68071-5192-01 NuCare 100 tablets — — FDA listed —
Aspirin 325 Mg Ec 69618-0015-01 Reliable 100 tablets — — FDA listed —
Aspirin 325 mg 69842-0927-14 CVS 500 tablets — — FDA listed —
Aspirin 325 Mg Ec 71205-0318-20 Proficient 20 tablets — — FDA listed —
Enteric Coated Aspirin Regular Strength 325 mg 71335-0157-01 Bryant 30 tablets — — FDA listed —
Regular Strength Enteric coated aspirin 325 mg 71335-0513-01 Bryant 30 tablets — — FDA listed —
Aspirin 325 Mg Ec 71335-1800-01 Bryant 30 tablets — — FDA listed —
Aspirin 325 mg 71610-0034-65 Aphena 100 tablets — — FDA listed —
Aspirin 325 mg 72036-0181-02 HARRIS 125 tablets — — FDA listed —
Aspirin 325 mg 72789-0556-07 PD-Rx 7 tablets — — FDA listed —
Aspirin Enteric Coated, Regular Strength 325 mg 77333-0035-20 Gendose 1 tablet — — FDA listed —
Aspirin 325 mg 79481-2270-05 Meijer 125 tablets — — FDA listed —
Aspirin 325 mg 80425-0293-01 Advanced 30 tablets — — FDA listed —
Aspirin 325 mg 81522-0018-11 FSA 100 tablets — — FDA listed —
Aspirin 325 mg 84269-2501-01 Wildman 2 tablets — — FDA listed —
Aspirin 325 mg 85111-0921-10 RMT 1000 tablets — — 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

🏛️
2011
On the market since
Jan 2011
📍
2026
Currently FDA-listed
15 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.

💊 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.
1000 tablets49483-0331-10 206 Rx · $2,304
100000 tablets this page49483-0331-00 No Medicaid data
100 tablets49483-0331-01 No Medicaid data
Drug total (last 4 qtrs): 206 Rx · 8,658 units · $2,304 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 Enteric Coated Aspirin Regular Strength (this brand).

Top reported reactions

Fatigue31,729
Dyspnoea27,102
Nausea26,290
Diarrhoea26,244
Dizziness22,241
Headache19,446
Asthenia18,649

Age at onset

Neonate871
Infant273
Child646
Adolescent306
Adult28,256
Elderly50,201

Reporter sex

508,138 reports
Male · 51%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization199,412
Death46,448
Life-threatening24,696
Disabling15,131
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 34,733 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
49483-0331-00 You're viewing this 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-331-00) — — 2011-04-10 Active
49483-0331-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-01) $0.0221 / ea $2.21 2011-04-10 Active
49483-0331-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-10) $0.0221 / ea $22.10 2011-04-10 Active

You're viewing the largest of 3 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 1000 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 49483-0331-00?
NDC 49483-0331-00 is a 100,000-count package — 100000 tablet, delayed release in 1 carton.
What is the difference between NDC 49483-0331-00 and NDC 49483-0331-01?
Both are Enteric Coated Aspirin Regular Strength 325 mg/3251 Tablet, Delayed Release — the drug itself is identical. NDC 49483-0331-00 is the 100,000-count package, while NDC 49483-0331-01 is the 100 tablets package.
What NDC number is used to bill for this package of Enteric Coated Aspirin Regular Strength 325 mg/3251 Tablet, Delayed Release?
Bill NDC 49483-0331-00 — the 11-digit billing format is 49483033100. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 FDA registers it as 49483-331-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49483-0331-00, written without dashes as 49483033100. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49483-0331-00, the first segment (49483) is the labeler code FDA assigned to Time-Cap Labs, Inc; the middle segment (0331) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Time-Cap Labs, Inc. 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 2 other package presentations of this same product, including 100 tablets (49483-0331-01), 1000 tablets (49483-0331-10). 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?
Time-Cap Labs, 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.

📄 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
🎯 Indications and Usage 38 words ▾

Uses temporarily relieves minor aches and pains Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 325 mg Aspirin

⏱️ Dosage and Administration 50 words ▾

Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

⚠️ Warnings 146 words ▾

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: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach 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

🧪 Active Ingredient 12 words ▾

Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

🎯 Purpose 3 words ▾

Purpose Pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49483-0330-10 · Time-Cap 49483-0333-01 · Time-Cap →
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.