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Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN, and CAFFEINE 250 mg; 250 mg; 65 mg Capsule, Coated — NDC 73598-1372-1 (Billing 73598-1372-01)

by JHK Inc dba American Safety & First Aid · 25 DOSE PACK in 1 BOX / 2 CAPSULE, COATED in 1 DOSE PACK

This is a package of Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN, and CAFFEINE 250 mg; 250 mg; 65 mg Capsule, Coated from JHK Inc dba American Safety & First Aid, marketed since Feb 2000 and currently FDA-listed. It is this product's only package size.

NDC 73598-1372-01
🏷️ FDA NDC (as labeled) 73598-1372-1 billing pads the package segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73598-1372-1
Product NDC 73598-1372
11-digit billing NDC 73598137201
UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Application # M013
SPL Set ID 87c5ad71-0448-4e0f-acee-bf9a1d38675e
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 2000-02-02
Route ORAL
Dosage form CAPSULE, COATED
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Why two NDCs? The FDA registers this code as 73598-1372-1 — a 5-4-1 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 package segment → 73598-1372-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter coated capsule containing three active ingredients commonly combined in pain and headache products. Acetaminophen and aspirin are pain relievers and fever reducers that work through different mechanisms. Caffeine is a stimulant typically included in these formulas to enhance pain relief and combat drowsiness. Products of this type are marketed as an OTC monograph drug, meaning they follow established FDA guidelines for this category rather than being individually reviewed.

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.
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
73598-1372-01 You're viewing this Main listing 25 DOSE PACK in 1 BOX / 2 CAPSULE, COATED in 1 DOSE PACK 2000-02-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extra Strength Pain Reliever 250 mg/1; 250 mg/1; 65 mgthis 73598-1372-01 JHK 2 capsules — — 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

🏛️
2000
On the market since
Feb 2000
📍
2026
Currently FDA-listed
26 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

LabelerJHK Inc dba American Safety & First Aid
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code73598
First marketedFeb 2000
Product typeHuman Otc Drug
Portfolio17 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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

Use temporarily relieves fever and minor aches and pains associated with: headache colds muscular aches menstrual discomfort toothaches minor arthritis pain

⏱️ Dosage and Administration 33 words ▾

Directions Adults 2 tablets, with water every 6 hours while symptoms persist; not to exceed 8 tablets in 24 hours or as directed by a doctor. Children under 12 years: consult a doctor.

⚠️ Warnings ~2 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 Liver Warning This product contains acetaminophen.

Severe liver damage may occur if you take: more than 8 tablets 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 a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (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 dosage 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 are allergic to aspirin with any other pain reliever/fever reducer if you have ever had an allergic reaction to any other pain reliever/fever reducer for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor with any other product containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask doctor before use if stomach bleeding warning applies to you you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease you are taking diuretic you have a history of stomach problems, such as heartburn Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of blood) diabetes gout arthritis When using this product do not exceed recommended dose.

Stop use and ask doctor if 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 ringing in the ears or loss of hearing occurs pain or fever persists or gets worse New symptoms occur Redness or swelling is present If pregnant or breastfeeding , ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 28 words ▾

Other Information do not use if packet is opened or torn store at room temperature 68º-77ºF (20º-25ºC) avoid excessive heat and humidity each caplet contains: Magnesium 0.58 mg

🧪 Active Ingredient 28 words ▾

Active ingredient (In Each Caplets) Purpose Acetaminophen 250 mg pain reliever/fever reducer Aspirin 250 mg (NSAID) Nonsteroidal Anti-Inflammatory Drug pain reliever/fever reducer Caffeine 65 mg pain reliever aid

🧪 Inactive Ingredients 19 words ▾

Inactive ingredient Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc

🎯 Purpose 28 words ▾

Active ingredient (In Each Caplets) Purpose Acetaminophen 250 mg pain reliever/fever reducer Aspirin 250 mg (NSAID) Nonsteroidal Anti-Inflammatory Drug pain reliever/fever reducer Caffeine 65 mg pain reliever aid

📄 Do Not Use 73 words ▾

Do not use if you are allergic to aspirin with any other pain reliever/fever reducer if you have ever had an allergic reaction to any other pain reliever/fever reducer for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor with any other product 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 40 words ▾

Ask doctor before use if stomach bleeding warning applies to you you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease you are taking diuretic you have a history of stomach problems, such as heartburn

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of blood) diabetes gout arthritis

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dose.

📄 Stop Use and Ask a Doctor If 57 words ▾

Stop use and ask doctor if 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 ringing in the ears or loss of hearing occurs pain or fever persists or gets worse New symptoms occur Redness or swelling is present

🤰 If Pregnant or Breast-Feeding 48 words ▾

If pregnant or breastfeeding , ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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 43 words ▾

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

📄 Questions or Comments 15 words ▾

Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST Manufactured for American Safety & First Aid Osceola, IN 46561

📄 Package Label / Principal Display Panel 97 words ▾

PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box This product is not manufactured or distributed by Novartis Owner of the registered trademark Excedrin ® . Product #1372 Extra Strength Pain Reliever Pain Reliever/Fever Reducer Active ingredient: Acetaminophen, Aspirin Caffeine Temporary relief from pain, fever, and inflammation Soothes muscle aches and minor arthritis pain These quality comfort caplets are formulated and packaged for use in the workplace and meet ANSI Z308. 1-2021 standards.

They are sealed in tamper-evident packets for safety and convenience. 50 Caplets • 2 Caplets Per Packet PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box

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

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 — Not published for this NDC No photo available yet for this listing.
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 JHK Inc dba American Safety & First Aid. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
JHK Inc dba American Safety & First Aid 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.
← 73598-1342-01 · JHK 73598-1392-01 · JHK →
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.