Home › NDC Lookup › Ingredients › Acetaminophen Aspirin And Caffeine › 69168-0285-37
Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated, 16-count — NDC 69168-0285-37 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated, 16-count — NDC 69168-285-37 (Billing 69168-0285-37)

by Allegiant Health · 1 BOTTLE in 1 CARTON / 16 TABLET, FILM COATED in 1 BOTTLE

This is a package of 16 tablets of Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated from Allegiant Health, marketed since Feb 2010 and currently FDA-listed.

NDC 69168-0285-37
🏷️ FDA NDC (as labeled) 69168-285-37 billing pads the product segment with a zero
This package
Contains16-count Pack sizes3 compare ↓
Product page 69168-0285-24 Also comes in: 20 tablets 69168-285-26 24 tablets 69168-285-24
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69168-285-37
Product NDC 69168-285
11-digit billing NDC 69168028537
RxCUI 308297
UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Application # M013
SPL Set ID 6197eff5-0351-42ef-bb3f-cbc26e6d0d14
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 2010-02-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Quick answers
  • RxCUI (RxNorm): 308297
Why two NDCs? The FDA registers this code as 69168-285-37 — 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 → 69168-0285-37. 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

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Migraine-labeled versions treat migraine. Headache and extra strength versions temporarily relieve minor aches and pains from things like headache, a col...
  • Take it by mouth with a full glass of water. Follow the directions on your product, because migraine versions and extra strength versions have different daily limits. Never take mo...
  • The caffeine can make you feel nervous, irritable or unable to sleep, and sometimes your heartbeat may feel fast. Cutting back on coffee and other caffeine while you use it can hel...
  • Stop and get help right away for a skin rash or blisters, hives, facial swelling or wheezing. Also stop for vomiting blood, black or bloody stools, stomach pain that won’t go away,...
📖 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.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 tablets 24 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69168-0285-24 69168-285-24 Main listing 1 BOTTLE in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE 2010-02-15 — Discontinued by firm
69168-0285-37 You're viewing this 1 BOTTLE in 1 CARTON / 16 TABLET, FILM COATED in 1 BOTTLE 2022-09-08 — Active
69168-0285-26 69168-285-26 1 BOTTLE in 1 CARTON / 20 TABLET, FILM COATED in 1 BOTTLE 2020-03-06 — Active

Pack size FAQ

What quantity is in this package?
This is a 16-count package — 1 bottle in 1 carton / 16 tablet, film coated in 1 bottle.
How does this package differ from NDC 69168-0285-26?
Both are Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 16-count one, while NDC 69168-0285-26 is the 20 tablets package.
What NDC number is used to bill for this package of Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 mgthis 69168-0285-37 Allegiant 16 tablets — — FDA listed —
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 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: 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

🏛️
2010
On the market since
Feb 2010
📍
2026
Currently FDA-listed
16 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.

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

LabelerAllegiant Health
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69168
First marketedFeb 2010
Product typeHuman Otc Drug
Portfolio113 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses temporary relief of minor aches and pains associated with ■ headache ■ common cold ■ sinusitis ■ toothache ■ muscular aches ■ arthritis ■ premenstrual and menstrual cramps

⏱️ Dosage and Administration 45 words ▾

Directions Do not exceed recommended dosage. Drink a full glass of water with each dose. Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. Children under 12 years: 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: 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 adult takes more than 8 tablets in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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 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 heart beat.

📦 Storage and Handling 33 words ▾

Other information store at 20º-25ºC (68º-77ºF) keep carton for full product information do not use if imprinted safety seal under cap is broken or missing you may report serious side effects to 1-888-952-0050

🧪 Active Ingredient 19 words ▾

Active ingredient (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg * nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients corn starch, cros- carmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

🎯 Purpose 8 words ▾

Purpose Pain reliever Pain reliever Pain reliever aid

📄 Do Not Use 44 words ▾

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 45 words ▾

Ask doctor before use if 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

📄 Ask a Doctor or Pharmacist Before Use If 48 words ▾

Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition

📄 Stop Use and Ask a Doctor If 77 words ▾

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away you feel faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts ringing in ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days painful area is red or swollen new symptoms occur

🤰 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 42 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immeaditely. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Package Label / Principal Display Panel 6 words ▾

Package/Label Principal Display Panel Headache Headache

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 Headache Relief Extra Strength (this brand).

Top reported reactions

Nausea14
Completed Suicide12
Headache12
Pruritus10
Dyspnoea9
Feeling Abnormal8
Hypertension8

Age at onset

Child1
Adult12
Elderly4

Reporter sex

155 reports
Male · 28%
Female · 71%
Unknown · 1%

Serious outcomes

Death29
Life-threatening5
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 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 Allegiant Health. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 20 tablets (69168-0285-26), 24 tablets (69168-0285-24). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Allegiant Health 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.
← 69168-0277-93 · Allegiant 69168-0288-36 · Allegiant →
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.