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Migraine Relief ACETAMINOPHEN, ASPIRIN and CAFFEINE 250 mg; 250 mg; 65 mg Tablet, 100-count — NDC 81522-0205-03 package photo

Migraine Relief ACETAMINOPHEN, ASPIRIN and CAFFEINE 250 mg; 250 mg; 65 mg Tablet, 100-count

by FSA STORE INC. · 1 BOTTLE, PLASTIC in 1 CARTON (81522-205-03) / 100 TABLET in 1 BOTTLE, PLASTIC
NDC 81522-0205-03
🏷️ FDA NDC (as labeled) 81522-205-03 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Sep 17, 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

⚠️
Other active recalls for Acetaminophen, Aspirin And Caffeine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jul 11, 2024 — Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. (Aurobindo Pharma USA Inc) · FDA recall D-0641-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81522-205-03
Product NDC 81522-205
11-digit billing NDC 81522020503
RxCUI 308297
UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E
UPC 0099581912031
Application # ANDA214039
SPL Set ID ec6b7017-cf12-09a7-e053-2995a90a2db9
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor; Central Nervous System Stimulant; Methylxanthine
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation; Central Nervous System Stimulation
Chemical class Anti-Inflammatory Agents, Non-Steroidal; Xanthines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-11
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Why two NDCs? The FDA registers this code as 81522-205-03 — 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 → 81522-0205-03. 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

LabelerFSA STORE INC.
Application holderGRANULES INDIA LTD
FDA applicationANDA214039 (ANDA)
Labeler code81522
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio41 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

📗 Our plain-language guide HelloPharmacist
  • The migraine-labeled products — like Excedrin Migraine and Amazon Basic Care Migraine Relief — are specifically approved to treat migraine and are generally taken as one dose (2 ta...
  • What's the difference between the migraine version and the regular headache version?
  • Be careful — many OTC cold, sinus, and pain products already contain acetaminophen. Stacking them with this product can quickly push you over the safe daily limit and raise your ri...
  • Can I take this with other pain relievers or cold medicines?
📖 Read our full Acetaminophen / Aspirin / Caffeine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 white
ShapeCapsule
ImprintI1
Size17 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 5Y0974F5PW
    Hydroxypropyl cellulose is a plant-derived thickener and binder made by chemically treating cellulose. In medicines, it helps hold tablets together, thickens liquids, and can form a protective coating on capsules.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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.

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

The official label also statescarnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extra Pain Relief 250 mg/1; 250 mg/1; 65 mg 49483-0370-00 TIME 20000 tablets $0.064 — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 63868-0485-01 CHAIN 100 tablets $0.064 — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 00113-0374-62 L. 24 tablets $0.065 — Availability likely —
Pain Reliever Plus 250 mg/1; 65 mg/1; 250 mg 00536-1326-01 Rugby 100 tablets $0.065 — Availability likely —
good neighbor pharmacy migraine relief 250 mg/1; 250 mg/1; 65 mg 24385-0365-71 Amerisource 50 tablets $0.065 — Availability likely —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 46122-0690-78 Amerisource 100 tablets $0.065 — Availability likely —
Acetaminophen, Aspirin and Caffeine 250 mg/1; 250 mg/1; 65 mg 57237-0348-01 Rising 100 tablets $0.065 — Availability likely —
Acetaminophen, Aspirin, Caffeine 250 mg/1; 250 mg/1; 65 mg 70000-0066-01 LEADER/ 100 tablets $0.065 — Availability likely —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 70000-0146-01 Cardinal 24 tablets $0.065 — Availability likely —
Leader Migraine Relief 250 mg/1; 250 mg/1; 65 mg 70000-0247-01 Cardinal 24 tablets $0.065 — Availability likely —
leader migraine relief 250 mg/1; 250 mg/1; 65 mg 70000-0611-01 Cardinal 80 tablets $0.065 — Availability likely —
foster and thrive migraine relief 250 mg/1; 250 mg/1; 65 mg 70677-1133-01 Strategic 50 tablets $0.065 — Availability likely —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 83324-0063-24 Chain 24 tablets $0.067 — Discontinued —
Migraine Relief 250 mg/1; 250 mg/1; 65 mg 83324-0099-24 CHAIN 24 tablets $0.067 — Availability likely —
Excedrin Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 00067-2000-02 Haleon 2 tablets — — FDA listed —
Excedrin Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 00067-2001-01 Haleon 2 tablets — — FDA listed —
Excedrin Extra Strength Headache 250 mg/1; 250 mg/1; 65 mg 00067-2002-01 Haleon 24 tablets — — FDA listed —
Excedrin Extra Strength Headache 250 mg/1; 250 mg/1; 65 mg 00067-2003-01 Haleon 100 tablets — — FDA listed —
Excedrin Extra Strength Geltabs 250 mg/1; 250 mg/1; 65 mg 00067-2021-20 Haleon 20 tablets — — FDA listed —
Excedrin Migraine Geltabs 250 mg/1; 250 mg/1; 65 mg 00067-2035-20 Haleon 20 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 00067-2039-02 Haleon 2 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 00067-2040-01 Haleon 2 tablets — — FDA listed —
Excedrin Migraine Relief 250 mg/1; 250 mg/1; 65 mg 00067-2042-01 Haleon 24 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 00067-8201-03 Haleon 300 tablets — — FDA listed —
Excedrin Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 00067-8202-03 Haleon 300 tablets — — FDA listed —
Excedrin Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 00067-8203-02 Haleon 100 tablets — — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 00113-1619-27 L. 80 tablets — — FDA listed —
good sense headache relief 250 mg/1; 250 mg/1; 65 mg 00113-1855-27 L. 80 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 00363-0374-62 Walgreen 24 tablets — — Discontinued —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 00363-0586-20 Walgreens 20 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 00363-0770-01 WALGREENS 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 00363-0865-25 Walgreens 250 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 00363-1150-25 Walgreens 250 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 00363-1235-60 Walgreen 20 tablets — — FDA listed —
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg 250 mg/1; 250 mg/1; 65 mg 00363-1320-12 WALGREENS 120 tablets — — FDA listed —
Walgreens Headache Relief Extra Strength 65 mg/1; 250 mg/1; 250 mg 00363-6693-12 Walgreens 120 tablets — — FDA listed —
Headache Relief 250 mg/1; 65 mg/1; 250 mg 00363-7012-01 WALGREENS 100 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 00363-7214-25 WALGREENS 250 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 00363-8992-10 WALGREENS 100 tablets — — FDA listed —
Acetaminophen Aspirin Caffeine 250 mg/1; 65 mg/1; 250 mg 00363-9680-10 WALGREEN 100 tablets — — Discontinued —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 11673-0070-01 TARGET 100 tablets — — FDA listed —
Up and Up Migraine Relief 250 mg/1; 250 mg/1; 65 mg 11673-0374-78 Target 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 11673-0686-20 TARGET 20 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 11822-0374-01 Rite 100 tablets — — FDA listed —
Pain Reliever Extra Strength 250 mg/1; 250 mg/1; 65 mg 11822-1590-02 Rite 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 11822-3343-06 Rite 200 tablets — — FDA listed —
Extra Strength Pain Relief 250 mg/1; 250 mg/1; 65 mg 21130-0037-01 BETTER 100 tablets — — FDA listed —
Acetaminophen Aspirin And Caffeine 250 mg/1; 250 mg/1; 65 mg 21130-0074-07 Better 24 tablets — — FDA listed —
Signature Care Migraine Relief 250 mg/1; 250 mg/1; 65 mg 21130-0569-62 Safeway 24 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 21130-0586-20 Safeway, 20 tablets — — FDA listed —
Acetaminophen, Aspirin and Caffeine 250 mg/1; 250 mg/1; 65 mg 21130-0681-05 Safeway, 50 tablets — — FDA listed —
Sedalmex Forte 250 mg/1; 250 mg/1; 65 mg 27854-0303-01 Belmora 40 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 29485-6486-02 Lil' 50 tablets — — FDA listed —
Extra Strenght Headache Relief 250 mg/1; 65 mg/1; 250 mg 29485-6538-06 Lil' 6 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 30142-0586-20 The 20 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 30142-0625-10 The 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 30142-0865-24 The 24 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 30142-0896-62 Kroger 24 tablets — — FDA listed —
Topcare Migraine Relief 250 mg/1; 250 mg/1; 65 mg 36800-0533-62 Topco 24 tablets — — FDA listed —
topcare migraine relief 250 mg/1; 250 mg/1; 65 mg 36800-0934-60 Topco 20 tablets — — FDA listed —
migraine formula 250 mg/1; 250 mg/1; 65 mg 37808-0374-78 H 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 37808-0586-20 H 20 tablets — — FDA listed —
Acetaminophen, Aspirin, and Caffeine 250 mg/1; 250 mg/1; 65 mg 37835-0531-01 Bi-Mart 100 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 41163-0334-08 United 24 tablets — — FDA listed —
Equaline migraine formula 250 mg/1; 250 mg/1; 65 mg 41163-0374-71 United 50 tablets — — FDA listed —
Headache Relief 65 mg/1; 250 mg/1; 250 mg 41226-0370-01 Kroger 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 41250-0334-08 Meijer 24 tablets — — Discontinued —
migraine formula 250 mg/1; 250 mg/1; 65 mg 41250-0374-71 Meijer 50 tablets — — FDA listed —
Care One migraine relief 250 mg/1; 250 mg/1; 65 mg 41520-0374-62 American 24 tablets — — FDA listed —
Vanquish Extra Strength 250 mg/1; 250 mg/1; 65 mg 42364-2208-01 DSE 100 tablets — — FDA listed —
migraine formula 250 mg/1; 250 mg/1; 65 mg 42507-0374-62 HyVee 24 tablets — — FDA listed —
Xpect Pain Away Extra Strength 250 mg/1; 250 mg/1; 65 mg 42961-0234-02 Cintas 100 tablets — — Discontinued —
Medique Pain Off 65 mg/1; 250 mg/1; 250 mg 47682-0238-13 Unifirst 2 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 49035-0433-06 Wal-Mart 100 tablets — — Discontinued —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 49035-0786-80 EQUATE 80 tablets — — FDA listed —
BioElectro Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 50066-0630-24 Genomma 24 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 50090-6093-00 A-S 576 tablets — — FDA listed —
Excedrin Extra Strength Headache 250 mg/1; 250 mg/1; 65 mg 50269-0158-01 JC 2 tablets — — FDA listed —
Exaprin Plus 250 mg/1; 250 mg/1; 65 mg 50332-0144-04 HART 2 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 50844-0258-08 L.N.K. 24 tablets — — FDA listed —
Arthriten Inflammatory Pain Formula 250 mg/1; 65 mg/1; 250 mg 52389-0237-28 Kobayashi 28 tablets — — FDA listed —
Migraine Relief 250 mg/1; 250 mg/1; 65 mg 53943-0305-03 DISCOUNT 100 tablets — — FDA listed —
Extraprin 250 mg/1; 250 mg/1; 65 mg 54257-0858-02 Magno-Humphries, 100 tablets — — FDA listed —
Headache Formula Extra Strength 250 mg/1; 250 mg/1; 65 mg 55301-0334-12 ARMY 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 55319-0511-10 Family 100 tablets — — FDA listed —
Acetaminophen, Aspirin and Caffeine 250 mg/1; 65 mg/1; 250 mg 55319-0680-10 FAMILY 100 tablets — — FDA listed —
Migraine Relief 250 mg/1; 250 mg/1; 65 mg 55319-0970-10 Family 100 tablets — — FDA listed —
Dolex Forte 250 mg/1; 250 mg/1; 65 mg 55758-0509-24 Pharmadel 24 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 55910-0345-08 DOLGENCORP, 24 tablets — — FDA listed —
DG Health migraine relief 250 mg/1; 250 mg/1; 65 mg 55910-0374-62 Dolgencorp, 24 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 55910-0440-01 Dollar 100 tablets — — FDA listed —
dg health migraine relief 250 mg/1; 250 mg/1; 65 mg 55910-0448-27 Dolgencorp 80 tablets — — FDA listed —
dg health headache relief 250 mg/1; 250 mg/1; 65 mg 55910-0639-27 Dolgencorp 80 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 55910-0686-20 Dolgencorp, 20 tablets — — FDA listed —
Publix Super Markets Inc 250 mg/1; 250 mg/1; 65 mg 56062-0305-02 PUBLIX 50 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 56062-0934-12 Publix 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 57243-0159-08 Salado 24 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 57243-0334-08 Salado 24 tablets — — FDA listed —
Migraine Relief 250 mg/1; 250 mg/1; 65 mg 57344-0205-01 AAA 24 tablets — — FDA listed —
Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 57896-0216-01 Geri-Care 100 tablets — — FDA listed —
Acetaminophen Aspirin And Caffeine 250 mg/1; 250 mg/1; 65 mg 58602-0817-02 Aurohealth 8 tablets — — FDA listed —
Acetaminophen Aspirin And Caffeine 250 mg/1; 250 mg/1; 65 mg 58602-0882-21 Aurohealth 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 59726-0011-50 P 50 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 59779-0334-06 CVS 200 tablets — — Discontinued —
migraine relief 250 mg/1; 250 mg/1; 65 mg 59779-0374-62 CVS 24 tablets — — FDA listed —
Acetaminophen, Aspirin and Caffeine 250 mg/1; 250 mg/1; 65 mg 62207-0680-47 Granules 500 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 63941-0159-12 Valu 100 tablets — — FDA listed —
Headache, Circle K 250 mg/1; 250 mg/1; 65 mg 66715-5438-03 Lil' 18 tablets — — FDA listed —
Extra Strength Headache, Circle K 250 mg/1; 65 mg/1; 250 mg 66715-5506-04 Lil' 50 tablets — — FDA listed —
Headache Relief, Extra Strength 24/7 Life by 7-Eleven 250 mg/1; 250 mg/1; 65 mg 66715-5641-04 Lil' 24 tablets — — FDA listed —
Extra Strength Headache, Caseys 4good 65 mg/1; 250 mg/1; 250 mg 66715-6338-03 Lil' 6 tablets — — FDA listed —
Excedrin Extra Strength, TRAVEL BASIX 250 mg/1; 250 mg/1; 65 mg 66715-6410-02 Lil 2 tablets — — FDA listed —
Extra Strength Headache, Lil Drug Store 250 mg/1; 250 mg/1; 65 mg 66715-6438-06 Lil' 50 tablets — — FDA listed —
Excedrin Migraine, TRAVEL BASIX 250 mg/1; 250 mg/1; 65 mg 66715-6449-03 Lil' 2 tablets — — FDA listed —
Excedrin Extra Strength, CVP HEALTH 250 mg/1; 250 mg/1; 65 mg 66715-6510-02 Lil 2 tablets — — FDA listed —
Excedrin Migraine, CVP HEALTH 250 mg/1; 250 mg/1; 65 mg 66715-6549-02 Lil' 2 tablets — — FDA listed —
Extra Strength Headache 250 mg/1; 65 mg/1; 250 mg 66715-6922-04 Lil' 50 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 66715-9749-03 Lil' 2 tablets — — FDA listed —
Excedrin Extra Strength 250 mg/1; 250 mg/1; 65 mg 66715-9810-02 Lil 2 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 67091-0112-10 WinCo 100 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 67414-0239-02 Jones 2 tablets — — FDA listed —
Excedrin Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 67751-0119-01 Navajo 2 tablets — — FDA listed —
Handy Solutions Headache Pain Relief 65 mg/1; 250 mg/1; 250 mg 67751-0215-01 Navajo 2 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 67751-0243-02 Navajo 2 tablets — — FDA listed —
Acetaminophen, Aspirin, Caffeine 250 mg/1; 65 mg/1; 250 mg 68071-3914-01 NuCare 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 69168-0285-24 Allegiant 24 tablets — — Discontinued —
Sedal3X 250 mg/1; 65 mg/1; 250 mg 69729-0055-40 OPMX 40 tablets — — FDA listed —
Artrifin 24 Caplets 250 mg/1; 65 mg/1; 250 mg 69729-0105-24 OPMX 24 tablets — — FDA listed —
Agrifen 250 mg/1; 65 mg/1; 250 mg 69729-0159-12 OPMX 12 tablets — — FDA listed —
Dolodol 65 mg/1; 250 mg/1; 250 mg 69729-0601-24 OPMX 24 tablets — — FDA listed —
Acetaminophen, Aspirin, Caffeine 65 mg/1; 250 mg/1; 250 mg 69842-0541-01 CVS 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 69842-0586-02 CVS 200 tablets — — FDA listed —
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg 250 mg/1; 250 mg/1; 65 mg 69842-0591-20 CVS 200 tablets — — FDA listed —
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg 250 mg/1; 250 mg/1; 65 mg 69842-0592-23 CVS 20 tablets — — FDA listed —
Acetaminophen Aspirin Caffeine 250 mg/1; 65 mg/1; 250 mg 69842-0680-10 CVS 100 tablets — — FDA listed —
Excedrin Extra Strength Headache 250 mg/1; 250 mg/1; 65 mg 70264-0045-01 R 2 tablets — — FDA listed —
EXTRA STRENGTH Headache Relief geltabs 250 mg/1; 250 mg/1; 65 mg 70692-0132-20 Strive 200 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 70692-0142-31 Strive 300 tablets — — FDA listed —
Acetaminophen, Aspirin and Caffeine 250 mg/1; 250 mg/1; 65 mg 71309-0079-03 Safrel 300 tablets — — FDA listed —
Pamprin Max Menstrual Pain Relief 250 mg/1; 250 mg/1; 65 mg 71687-3006-06 Focus 24 tablets — — FDA listed —
Migraine Relief 250 mg/1; 250 mg/1; 65 mg 72036-0305-03 HARRIS 100 tablets — — FDA listed —
GenCare Headache Relief 65 mg/1; 250 mg/1; 250 mg 72090-0007-02 Pioneer 300 tablets — — FDA listed —
GenCare Headache Relief 250 mg/1; 250 mg/1; 65 mg 72090-0033-01 Pioneer 300 tablets — — Discontinued —
basic care headache relief 250 mg/1; 250 mg/1; 65 mg 72288-0252-27 Amazon.com 80 tablets — — FDA listed —
basic care migraine relief 250 mg/1; 250 mg/1; 65 mg 72288-0295-27 Amazon.com 80 tablets — — FDA listed —
basic care migraine relief 250 mg/1; 250 mg/1; 65 mg 72288-0374-82 Amazon.com 200 tablets — — FDA listed —
Amazon Basic Care Migraine Relief 250 mg/1; 250 mg/1; 65 mg 72288-0376-20 Amazon.com 200 tablets — — FDA listed —
TopCare EXTRA STRENGTH Headache Relief 250 mg/1; 250 mg/1; 65 mg 76162-0142-01 Topco 100 tablets — — FDA listed —
Migraine Formula 250 mg/1; 250 mg/1; 65 mg 79481-0211-00 Meijer, 80 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 79903-0044-20 WAL-MART 200 tablets — — FDA listed —
Acetaminophen Aspirin And Caffeine 250 mg/1; 250 mg/1; 65 mg 79903-0216-10 WALMART 100 tablets — — FDA listed —
Headache Relief 250 mg/1; 65 mg/1; 250 mg 79903-0370-20 Walmart 200 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 80513-0362-15 Advanced 150 tablets — — FDA listed —
Migraine Relief 250 mg/1; 250 mg/1; 65 mgthis 81522-0205-03 FSA 100 tablets — — FDA listed —
ValuMeds Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 82725-1023-01 Cabinet 300 tablets — — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 82804-0002-30 Proficient 30 tablets — — FDA listed —
Acetaminophen, Aspirin, Caffeine 250 mg/1; 65 mg/1; 250 mg 82804-0008-30 Proficient 30 tablets — — FDA listed —
Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mg 82804-0163-60 Proficient 60 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 83324-0331-01 Chain 100 tablets — — FDA listed —
Nuvicare Headache Relief 65 mg/1; 250 mg/1; 250 mg 84324-0007-01 NUVICARE 100 tablets — — FDA listed —
Excedrin Extra Strength Headache 250 mg/1; 250 mg/1; 65 mg 85237-1868-01 Select 2 tablets — — FDA listed —
Excedrin Migraine 250 mg/1; 250 mg/1; 65 mg 85237-1871-01 Select 2 tablets — — FDA listed —
Medique Pain Off 65 mg/1; 250 mg/1; 250 mg 85766-0173-01 Sportpharm 2 tablets — — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 85766-0180-01 Sportpharm 100 tablets — — FDA listed —
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg 250 mg/1; 250 mg/1; 65 mg 85786-0105-90 Farmacias 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 85828-0285-93 Grocery 24 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 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 Migraine Relief (this brand).

Top reported reactions

Pain15,072
Fatigue14,479
Nausea13,516
Headache12,099
Arthralgia10,927
Dyspnoea10,540
Vomiting9,979

Age at onset

Neonate574
Infant287
Child1,272
Adolescent1,335
Adult21,472
Elderly7,053

Reporter sex

198,435 reports
Male · 35%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization70,582
Life-threatening13,207
Disabling9,156
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 15,251 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 Marketing startStatus
81522-0205-03 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (81522-205-03) / 100 TABLET in 1 BOTTLE, PLASTIC 2023-01-11 Active

🧭 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

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 81522-205-03, 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: 81522-0205-03, written without dashes as 81522020503. 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 81522-0205-03, the first segment (81522) is the labeler code FDA assigned to FSA STORE INC.; the middle segment (0205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 FSA STORE INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FSA STORE 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 4 words ▾

Use ■ treats migraine

⏱️ Dosage and Administration 52 words ▾

Directions ■ do not use more than directed ■ adults: take 2 caplets with a glass of water ■ if symptoms persist or worsen, ask your doctor ■ do not take more than 2 caplets in 24 hours, unless directed by a doctor ■ under 18 years of age: ask a doctor

⚠️ Warnings ~3 min read ▾

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 Acetaminophen may cause severe skin reactions.

Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Allergy alert Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 2 caplets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product 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 Medication overuse headache warning Headaches may worsen if this product is used for 10 or more days per month. Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee.

Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. Do not use ■ if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if ■ you have never had migraines diagnosed by a health professional ■ you have a headache that is different from your usual migraines ■ you have the worst headache of your life ■ you have fever and stiff neck ■ you have headaches beginning after or caused by head injury, exertion, coughing or bending ■ you experienced your first headache after the age of 50 ■ you have daily headaches ■ you have a migraine so severe as to require bed rest ■ you have liver disease ■ 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 ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have vomiting with your migraine headache Ask a doctor or pharmacist before use if you are ■ taking a prescription drug for: ■ diabetes ■ gout ■ arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug ■ taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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 ■ your migraine is not relieved or worsens after first dose ■ new or unexpected symptoms occur ■ ringing in the ears or loss of hearing occurs If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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. In case of overd…

📦 Storage and Handling 34 words ▾

Other information ■ store at controlled room temperature 20º to 25ºC (68º to 77ºF) ■ close cap tightly after use ■ read all product information before using. ■ keep this box for important information

🧪 Active Ingredient 23 words ▾

Active ingredient(s) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug Purpose Pain reliever Pain reliever Pain reliver aid

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide

🎯 Purpose 8 words ▾

Purpose Pain reliever Pain reliever Pain reliver aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81522-0204-02 · FSA 81522-0220-01 · FSA →
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.