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EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE 250 mg; 250 mg; 65 mg Tablet, Film Coated, 60-count — NDC 82804-0163-60 package photo

EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE 250 mg; 250 mg; 65 mg Tablet, Film Coated, 60-count

by Proficient Rx LP · 60 TABLET, FILM COATED in 1 BOTTLE (82804-163-60)
NDC 82804-0163-60
🏷️ FDA NDC (as labeled) 82804-163-60 billing pads the product segment with a zero
OTC 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) 82804-163-60
Product NDC 82804-163
11-digit billing NDC 82804016360
NCPDP billing unit EA — each (per item)
RxCUI 308297
UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E
UPC 0382804163601
Application # M013
SPL Set ID bf365bfc-35cc-47f9-a50b-ff2b38d7316b
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 OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-02-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
GCN Seq No 040186
GCN 10414
HICL code 001807
Ingredient (HICL) Aspirin/Acetaminophen/Caffeine
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 PAIN RELIEVR 250-250-65MG CPLT
FDB brand name Pain Reliever
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 82804-163-60 — 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 → 82804-0163-60. 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

LabelerProficient Rx LP
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code82804
First marketedFeb 2020
Product typeHuman Otc Drug
Portfolio1,723 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 PAIN RELIEVR 250-250-65MG CPLT Ingredient Aspirin/Acetaminophen/Caffeine
📗 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
Imprint44;334
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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statescorn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, 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 mg 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 mgthis 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: 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Extra Strength Pain Reliever (this brand).

Top reported reactions

Fatigue20,906
Pain18,476
Nausea18,183
Headache17,141
Toxicity To Various Agents15,847
Dyspnoea15,024
Pyrexia14,585

Reporter sex

253,819 reports

Serious outcomes

Death49,998
Disabling12,032
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 27,931 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
82804-0163-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE (82804-163-60) 2024-10-31 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

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 82804-163-60, 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: 82804-0163-60, written without dashes as 82804016360. 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 82804-0163-60, the first segment (82804) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0163) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP 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 1 words ▾

USES

⏱️ Dosage and Administration 47 words ▾

Directions • do not use more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • children under 12: ask a doctor

⚠️ Warnings ~1 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: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: • rash • skin reddening • blisters If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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 • 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) • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed 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.

🧪 Active Ingredient 17 words ▾

Active ingredients (in each caplet) ACETAMINOPHEN 250 MG ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug) CAFFEINE 65 MG

🧪 Inactive Ingredients 21 words ▾

INACTIVE INGREDIENTS corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

🎯 Purpose 7 words ▾

Purposes PAIN RELIEVER - PAIN RELIEVER AID

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82804-0162-30 · Proficient 82804-0164-90 · Proficient →
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.