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Bayer Aspirin Regimen enteric coated 325 mg Tablet, Coated, 100-count — NDC 00280-2110-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bayer Aspirin Regimen enteric coated 325 mg Tablet, Coated, 100-count — NDC 0280-2110-10 (Billing 00280-2110-10)

by Bayer HealthCare LLC. · 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Bayer Aspirin Regimen enteric coated 325 mg Tablet, Coated from Bayer HealthCare LLC., marketed since Jan 2015 and currently FDA-listed. It is this product's only package size.

NDC 00280-2110-10
🏷️ FDA NDC (as labeled) 0280-2110-10 billing pads the labeler segment with a zero
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 →

NDC database record

One package, one record: these facts belong to NDC 0280-2110-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0280 labeler · 2110 product · 10 package
Package marketed since
Jan 12, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0000000000000
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-2110-10
Product NDC 0280-2110
11-digit billing NDC 00280211010
NCPDP billing unit EA — each (per item)
RxCUI 198467, 387090
UNII R16CO5Y76E
UPC 0000000000000
Application # M013
SPL Set ID 0c6ae05f-7634-34d1-e054-00144ff88e88
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 2015-01-11
Route ORAL
Dosage form TABLET, COATED
Substance ASPIRIN

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

GPI-14 64100010000605
GPI class Bayer Aspirin
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 BAYER ASPIRIN EC 325 MG TABLET
FDB brand name Aspirin Ec
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 004381
  • GCN: 16720
  • GPI-14 (Medi-Span): 64100010000605
  • HICL (First Databank): 001820
  • AHFS class code: 20:12.18.00
  • RxCUI (RxNorm): 198467
Why two NDCs? The FDA registers this code as 0280-2110-10 — a 4-4-2 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 labeler segment → 00280-2110-10. 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.

Clinical

Label name BAYER ASPIRIN EC 325 MG TABLET Ingredient Aspirin
📗 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.

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
00280-2110-10 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2015-01-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aspirin 325 mg 00536-1054-05 Rugby 500 tablets $0.011 — Discontinued —
Aspirin 325 mg 63868-0352-03 CHAIN 300 tablets $0.011 — Discontinued —
Aspirin 325 mg 46122-0691-78 Amerisource 100 tablets $0.017 — Availability likely —
Aspirin 325 mg 70677-1189-01 Strategic 100 tablets $0.017 — Availability likely —
Aspirin 325 mg 70000-0253-02 Cardinal 100 tablets $0.017 — Availability likely —
Aspirin 325 mg 83324-0066-01 Chain 100 tablets $0.017 — Availability likely —
McKesson Aspirin 325 mg 68599-1311-03 McKesson 2 tablets $0.017 — Availability likely —
Aspirin 325 mg 83324-0205-01 CHAIN 100 tablets $0.017 — Availability likely —
Enteric Aspirin 325 mg 63868-0898-10 CHAIN 100 tablets $0.019 — Discontinued —
Buffered Aspirin 325 mg 70000-0147-01 Cardinal 130 tablets $0.021 — Availability likely —
Tri-Buffered Aspirin 325 mg 00904-2015-59 Major 100 tablets $0.021 — Discontinued —
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 mgthis 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/3251 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 — — Discontinued —
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 —
Aspirin 325 mg 17714-0010-01 Advance 100 tablets — — FDA listed —
Geritrex Aspirin 325 mg 54162-0940-90 Geritrex 1000 tablets — — FDA listed —
Aspirin 325 mg 54738-0541-01 Richmond 100 tablets — — FDA listed —
Aspirin 325 mg 49483-0011-00 TIME 100000 tablets — — FDA listed —
Aspirin 325 mg 50090-6195-08 A-S 100 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 50269-0006-06 JC 12 tablets — — FDA listed —
Circle K Aspirin 325 325 mg 66715-5504-04 Lil 100 tablets — — FDA listed —
Lil Drug Store Aspirin 325 325 mg 66715-6840-06 Lil 100 tablets — — FDA listed —
Tri-Buffered Aspirin 325 mg 71205-0517-30 Proficient 30 tablets — — FDA listed —
Medique at Home Aspirin 325 mg 85766-0125-01 Sportpharm 2 tablets — — FDA listed —
Aspirin 325 mg 21130-0957-14 Better 500 tablets — — Discontinued —
Aspirin Regular Strength 325 mg 41250-0118-11 Meijer 100 tablets — — Discontinued —
Aspirin 325 mg 53185-0249-12 Athlete's 100 tablets — — FDA listed —
Drug Mart Effervescent Pain Relief 325 mg 53943-0431-36 Discount 2 tablets — — FDA listed —
Dollar General Effervescent Pain Reliever 325 mg 55910-0040-36 Dolgencorp, 2 tablets — — FDA listed —
Publix Fast Relief Effervescent - Original Flavor 325 mg 56062-0358-36 PUBLIX 2 tablets — — FDA listed —
Aspirin 325 mg 63941-0118-19 VALU 300 tablets — — FDA listed —
Best Choice Effervescent Pain Reliever 36 325 mg 63941-0241-12 VALU 2 tablets — — FDA listed —
Aspirin 325 mg 69396-0173-01 Trifecta 1000 tablets — — FDA listed —
Aspirin 325 mg 77333-0050-20 Gendose 1 tablet — — FDA listed —
Aspirin 325 mg 79481-1570-01 Meijer 100 tablets — — FDA listed —
HEB Effervescent Pain Relief 325 mg 37808-0861-36 H. 2 tablets — — FDA listed —
Aspirin 325 mg 37835-0577-01 Bi-Mart 100 tablets — — FDA listed —
Aspirin 325 mg 37835-0738-02 Bi-Mart 100 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 41520-0157-78 FOODHOLD 100 tablets — — FDA listed —
Medi-First Aspirin 325 mg 47682-0617-13 Unifirst 2 tablets — — FDA listed —
Aspirin 325 mg 55910-0249-29 DOLGENCORP, 150 tablets — — FDA listed —
aspirin 325 mg 56062-0118-11 PUBLIX 100 tablets — — FDA listed —
Aspirin NSAID 325 mg 63941-0157-12 Valu 100 tablets — — FDA listed —
BAYER Aspirin Original, CVP HEALTH 325 mg 66715-6526-02 Lil' 4 tablets — — FDA listed —
Aspirin 325 mg 68998-0018-11 Marc 100 tablets — — FDA listed —
Extra Strength Aspirin 325 mg 69517-0002-05 HealthLife 500 tablets — — Discontinued —
Aspirin Packs 325 mg 70385-2006-02 Sina 2 tablets — — FDA listed —
Aspirin 325 mg 71679-0302-00 Health 28500 tablets — — FDA listed —
Aspirin 325 mg 82804-0237-04 Proficient 4 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 85237-1828-01 Select 1 tablet — — FDA listed —
Signature Select Effervescent Pain Relief 325 mg 21130-0295-36 Safeway 2 tablets — — FDA listed —
TopCare Effervescent Pain Relief 325 mg 36800-0789-36 TOPCO 2 tablets — — FDA listed —
Bufferin Regular Strength Pain Relief 325 mg 50066-0610-13 Genomma 130 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 50269-0005-06 JC 24 tablets — — FDA listed —
Bayer 325 mg 66715-9726-02 Lil' 4 tablets — — FDA listed —
Aspirin 325 mg 68788-8256-01 Preferred 100 tablets — — FDA listed —
Thompson Aspirin 325 mg 73408-0618-33 Thompson 2 tablets — — FDA listed —
Aspirin 325 mg 82804-0167-60 Proficient 60 tablets — — FDA listed —
Extra Strength Aspirin 325 mg 83586-0115-01 HHH 100 tablets — — FDA listed —
Physicians Care Aspirin 325 mg 00924-0105-00 Acme 2 tablets — — FDA listed —
Aspirin 325 mg 37808-0157-12 H 100 tablets — — Discontinued —
Regular Strength Aspirin 325 mg 41226-0011-32 Kroger 300 tablets — — FDA listed —
ASPIRIN 325 mg 42507-0018-11 HYVEE 100 tablets — — FDA listed —
Aspirin 325 mg 50804-0157-12 Geiss, 100 tablets — — FDA listed —
Aspirin 325 mg 58228-0071-01 PROSTAT 20000 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 72476-0018-11 RETAIL 100 tablets — — FDA listed —
Pain Relief Aspirin 325 mg 11822-0157-02 Rite 100 tablets — — FDA listed —
Aspirin 325 mg 41163-0157-12 United 100 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 47682-0456-47 Unifirst 2 tablets — — FDA listed —
Aspirin 325 mg 50844-0157-12 L.N.K. 100 tablets — — FDA listed —
Aspirin 325 mg 63941-0249-12 Valu 100 tablets — — Discontinued —
Winco Foods Effervescent Pain Relief 325 mg 67091-0448-36 Winco 2 tablets — — FDA listed —
ULINE Aspirin 325 mg 69790-0616-33 ULINE 2 tablets — — FDA listed —
Aspirin 325 mg 72036-0018-11 HARRIS 100 tablets — — FDA listed —
Aspirin 325 mg 85111-0901-10 RMT 1000 tablets — — FDA listed —
Aspirin 325 mg 50332-0139-03 HART 50 tablets — — FDA listed —
Coated Aspirin 325 mg 50844-0254-12 L.N.K. 100 tablets — — FDA listed —
Aspirin 325 mg 53943-0157-12 Discount 100 tablets — — FDA listed —
Family Wellness Pain Reliever 325 mg 55319-0870-36 FAMILY 2 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 00280-2000-01 Bayer 300 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 00924-6020-02 Acme 100 tablets — — FDA listed —
Aspirin 325 mg 36800-0157-12 Topco 100 tablets — — FDA listed —
Medique at Home Aspirin 325 mg 47682-0533-33 Unifirst 2 tablets — — FDA listed —
Aspirin 325 mg 49035-0157-06 Wal-Mart 200 tablets — — Discontinued —
CVS Effervescent Pain Reliever 325 mg 51316-0359-36 CVS 2 tablets — — FDA listed —
Aspirin 325 mg 55301-0157-12 ARMY 100 tablets — — FDA listed —
Rapidol Aspirin 325 mg 55758-0363-60 Pharmadel 60 tablets — — FDA listed —
Aspirin 325 mg 60760-0930-24 St. 24 tablets — — Discontinued —
BAYER Aspirin Original, TRAVEL BASIX 325 mg 66715-6426-02 Lil' 4 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 67751-0129-01 Navajo 2 tablets — — FDA listed —
Meijer Effervescent Pain Relief 325 mg 79481-0073-06 Meijer 2 tablets — — FDA listed —
Quality Choice Effervescent Pain Relief 325 mg 83324-0018-36 CHAIN 2 tablets — — FDA listed —
Medi-First Plus Aspirin 325 mg 47682-0618-33 Unifirst 2 tablets — — FDA listed —
Unishield Aspirin 325 mg 49314-1163-03 Unishield 2 tablets — — FDA listed —
Aspirin 325 mg 57243-0157-12 Salado 100 tablets — — FDA listed —
Direct Safety Aspirin 325 mg 61245-0616-13 Direct 2 tablets — — FDA listed —
Aspirin Regular Strength 325 mg 00363-0157-14 Walgreen 500 tablets — — FDA listed —
Bayer Genuine Aspirin 325 mg 70264-0013-01 R 100 tablets — — FDA listed —
Aspirin 50 CT 325 mg 73598-1112-01 JHK 50 tablets — — FDA listed —
Regular strength aspirin 325 mg 11673-0188-53 TARGET 500 tablets — — FDA listed —
Equaline Effervescent Pain Reliever 325 mg 41163-0741-36 UNITED 2 tablets — — FDA listed —
Good Sense Effervescent Pain Relief 325 mg 50804-0422-36 Perrigo 2 tablets — — FDA listed —
Aspirin 325 mg 57344-0018-11 AAA 100 tablets — — FDA listed —
Aspirin 325 mg 57896-0901-01 Geri-Care 100 tablets — — FDA listed —
Travel Savvy Aspirin 325 mg 59961-0616-15 Bellegrove 2 tablets — — FDA listed —
Aspirin 325 mg 72789-0574-25 PD-Rx 25 tablets — — FDA listed —
Aspirin 325 mg 21130-0758-53 BETTER 500 tablets — — FDA listed —
Medique Products Aspirin 325 mg 47682-0616-13 Unifirst 2 tablets — — FDA listed —
Aspirn 325 mg 51662-1583-01 HF 2 tablets — — FDA listed —
Market Basket Effervescent Pain Relief 325 mg 53942-0883-36 DEMOULAS 2 tablets — — FDA listed —
Aspirin 325 mg 69396-0158-01 Trifecta 100 tablets — — FDA listed —
Aspirin 325 mg 69732-0008-01 Hi-Tech 200 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

🏛️
2015
On the market since
Jan 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.

What it looks like

Color yellow
ShapeOval
ImprintBAYER;325
Size15 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerBayer HealthCare LLC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedJan 2015
Product typeHuman Otc Drug
Portfolio240 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 49 words ▾

Uses for the temporary relief of minor aches and pains or as recommended by your doctor. 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 Bayer Safety Coated 325 mg Aspirin

⏱️ Dosage and Administration 45 words ▾

Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 caplets every 4 hours not to exceed 12 caplets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

⚠️ Warnings 147 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 asthma (wheezing) shock 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 caplet) Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients lack iron oxide, brown iron oxide, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer type C, polysorbate 80, powdered cellulose, propylene glycol, shellac, sodium lauryl sulfate, triacetin, triethyl citrate

🎯 Purpose 3 words ▾

Purpose Pain reliever

📄 Do Not Use 31 words ▾

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients

📄 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 18 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis

📄 Stop Use and Ask a Doctor If 77 words ▾

Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health 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.

📄 Other Information 13 words ▾

Other information save carton for full directions and warnings store at room temperature

📄 Questions or Comments 9 words ▾

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

📄 Package Label / Principal Display Panel 1 words ▾

BayerAspirinRegimen325

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

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 Aspirin — the ingredient across all brands.

Top reported reactions

Fatigue34,124
Nausea28,891
Dyspnoea28,763
Diarrhoea28,188
Dizziness24,021
Headache21,809
Asthenia19,887

Age at onset

Neonate883
Infant286
Child706
Adolescent352
Adult31,940
Elderly56,134

Reporter sex

560,673 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization212,360
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 35,972 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) — 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 "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 Bayer HealthCare LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer HealthCare LLC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.