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Acetaminophen 325 mg Tablet, 100-count — NDC 82568-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen 325 mg Tablet, 100-count — NDC 82568-0001-1 (Billing 82568-0001-01)

by AARNA USA INC. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Acetaminophen 325 mg Tablet from AARNA USA INC., marketed since May 2025 and currently FDA-listed; retail pharmacies pay about $0.0233 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 82568-0001-01
🏷️ FDA NDC (as labeled) 82568-0001-1 billing pads the package segment with a zero
This package
Contains100-count Cost per ea$0.0233 NADAC Per package$2.33 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2033/unit — full pricing hub ↓
Main listing for product 82568-0001 · Also comes in: 100 tablets 82568-0001-3 1000 tablets 82568-0001-2
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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 (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
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) 82568-0001-1
Product NDC 82568-0001
11-digit billing NDC 82568000101
NCPDP billing unit EA — each (per item)
RxCUI 313782
UNII 362O9ITL9D
UPC 0382568000112
Application # M013
SPL Set ID 33f0e822-28af-9bb2-e063-6294a90a5175
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-15
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN

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

GPI-14 64200010000310
GCN Seq No 004489
GCN 16964
HICL code 001866
Ingredient (HICL) Acetaminophen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3E
Therapeutic class — specific (HIC3) Analgesic/Antipyretics,Non-Salicylate
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name ACETAMINOPHEN 325 MG TABLET
FDB brand name Acetaminophen
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 004489
  • GCN: 16964
  • GPI-14 (Medi-Span): 64200010000310
  • HICL (First Databank): 001866
  • AHFS class code: 28:08.16.00
  • RxCUI (RxNorm): 313782
Why two NDCs? The FDA registers this code as 82568-0001-1 — 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 → 82568-0001-01. 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.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ACETAMINOPHEN 325 MG TABLET Ingredient Acetaminophen
📖 What it is MedlinePlus · NLM

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.023 $2.33 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2033 $20.33 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 Mar 2026 Jun 2026 Sep 2026 $0.026 $0.023
▼ Down 11% over the last 9 months.
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 Per unit Per pack Marketing startMarketing endStatus
82568-0001-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE $0.0233 / ea $2.33 2025-05-15 — Active
82568-0001-02 82568-0001-2 1000 TABLET in 1 BOTTLE $0.0233 / ea $23.33 2025-05-15 — Active
82568-0001-03 82568-0001-3 100 TABLET in 1 PACKAGE $0.0233 / ea $2.33 2025-05-15 — Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0233 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 82568-0001-03?
Both are Acetaminophen 325 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 82568-0001-03 is the 100 tablets package.
What NDC number is used to bill for this package of Acetaminophen 325 mg Tablet?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense pain relief 325 mg 00113-0403-78 L. 100 tablets $0.023 — Availability likely —
Rugby Regular Strength Acetaminophen 325 mg 00536-1327-01 RUGBY 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 00904-6773-61 Major 100 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 46122-0390-78 AmeriSource 100 tablets $0.023 — Availability likely —
Acetaminophen Regular Strength 325 mg 46122-0430-78 Amerisource 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 49483-0340-01 TIME 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 57237-0346-01 Rising 100 tablets $0.023 — Availability likely —
McKesson Acetaminophen 325 325 mg 68599-4679-09 McKesson 2 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 70677-1119-01 STRATEGIC 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mgthis 82568-0001-01 AARNA 100 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 83324-0076-01 CHAIN 100 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 63868-0082-10 Chain 100 tablets $0.025 — Discontinued +6%
Regular Strength Acetaminophen 325 mg 70000-0092-01 CARDINAL 100 tablets $0.026 — FDA listed +12%
Pain Reliever 325 mg 00363-9026-10 WALGREENS 100 tablets — — FDA listed —
Henry Schein Acetaminophen 325 mg 00404-0714-13 Henry 2 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8397-05 NCS 15 tablets — — Discontinued —
Acetaminophen 325 mg 00615-8398-67 NCS 60 tablets — — Discontinued —
Acetaminophen 325 mg 00615-8608-05 NCS 15 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8609-67 NCS 60 tablets — — FDA listed —
Acetaminophen 325mg 325 mg 10135-0828-01 Marlex 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 11822-0104-01 Rite 100 tablets — — FDA listed —
Pharbetol Regular strength 325 mg 16103-0353-07 Pharbest 60 tablets — — FDA listed —
Acetaminophen 325 mg 17714-0012-01 Advance 100 tablets — — FDA listed —
Pharbetol Regular strength 325 mg 17856-0353-01 ATLANTIC 100 tablets — — FDA listed —
Pain Relief 325 mg 21130-0043-01 BETTER 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 30142-0052-21 KROGER 100 tablets — — FDA listed —
Aurophen Regular Strength 325 mg 30142-0184-21 KROGER 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 36800-0900-02 TopCo 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 41163-0514-02 United 100 tablets — — FDA listed —
Regular Strength Acetaminophen 325 mg 41226-0340-01 KROGER 100 tablets — — FDA listed —
pain relief 325 mg 41250-0403-78 Meijer 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 41250-0501-02 Meijer 100 tablets — — Discontinued —
PAIN RELIEF Regular Strength 325 mg 41520-0606-02 AMERICAN 100 tablets — — FDA listed —
Pain Relief 325 mg 42507-0501-02 HYVEE 100 tablets — — FDA listed —
Medique APAP 325 mg 47682-0057-13 Unifirst 2 tablets — — FDA listed —
Medi-First Non-Aspirin 325 mg 47682-0058-13 Unifirst 2 tablets — — FDA listed —
Medi-First Plus Non-Aspirin 325 mg 47682-0059-33 Unifirst 2 tablets — — FDA listed —
Dover Aminofen 325 mg 47682-0060-13 Unifirst 2 tablets — — FDA listed —
Medique APAP 325 mg 47682-0145-13 Unifirst 2 tablets — — FDA listed —
Dover Aminophen 325 mg 47682-0303-13 Unifirst 2 tablets — — FDA listed —
Medique at Home APAP 325 mg 47682-0434-33 Unifirst 2 tablets — — FDA listed —
Medi-First Non-Aspirin 325 mg 47682-0803-13 Unifirst 2 tablets — — FDA listed —
MEDI FIRST PLUS Non-Aspirin 325 mg 47682-0903-33 Unifirst 2 tablets — — FDA listed —
Ringl 325 mg 49873-0082-01 Sato 30 tablets — — FDA listed —
Rugby Regular Strength Acetaminophen 325 mg 50090-5971-06 A-S 50 tablets — — FDA listed —
Cetafen 325 mg 50332-0148-01 HART 1000 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0458-10 Kenvue 1000 tablets — — Discontinued —
TYLENOL Regular Strength 325 mg 50580-0475-10 Kenvue 1000 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0495-01 Kenvue 100 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0496-60 Kenvue 100 tablets — — FDA listed —
MEDIQUE APAP acetaminophen 325 mg 51662-1273-02 HF 2 tablets — — FDA listed —
acetaminophen 325 mg 51662-1665-02 HF 2 tablets — — FDA listed —
CareALL Acetaminophen 325 mg 51824-0061-02 New 2400 tablets — — FDA listed —
CareALL Acetaminophen 325 mg 51824-0085-01 New 100 tablets — — FDA listed —
Duralgina 325 mg 53145-0013-71 Menper 30 tablets — — FDA listed —
Clear Choice Regular Strength Pain Reliever 325 mg 53185-0005-00 Athlete's 100 tablets — — FDA listed —
Medline 325 mg 53329-0194-30 Medline 100 tablets — — FDA listed —
Pain Relief 325 mg 53942-0101-02 Demoulas 100 tablets — — FDA listed —
Pain Relief 325 mg 53943-0201-02 DISCOUNT 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 54257-0720-02 Magno-Humphries, 100 tablets — — FDA listed —
Acetaminophen 325 mg 54738-0548-01 Richmond 100 tablets — — FDA listed —
Acetaminophen 325 mg 55154-7899-00 Cardinal 10 tablets — — FDA listed —
Acetaminophen Regular strength 325 mg 55289-0563-01 PD-Rx 100 tablets — — FDA listed —
dg health pain relief 325 mg 55910-0697-78 Dolgencorp, 100 tablets — — FDA listed —
Pain Relief 325 mg 57344-0301-06 AAA 500 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 57896-0102-01 Geri-Care 100 tablets — — FDA listed —
Acetaminophen 325 mg 58228-0061-01 Prostat 20000 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 58602-0748-40 Aurohealth 500 tablets — — FDA listed —
Aurophen Regular Strength 325 mg 58602-0754-07 Aurohealth 24 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 58602-0775-21 Aurohealth 100 tablets — — FDA listed —
Travel Savvy Non-Aspirin 325 mg 59961-0151-15 Bellegrove 2 tablets — — FDA listed —
Direct Safety Aspirin Free 325 mg 61245-0145-13 Conney 2 tablets — — FDA listed —
Regular Strength Pain Reliever 325 mg 62936-0102-01 INGLES 100 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 63941-0456-02 VALU 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 67091-0132-10 WinCo 100 tablets — — FDA listed —
Acetaminophen 325 mg 68071-3454-03 NuCare 30 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 68071-3565-00 NuCare 100 tablets — — FDA listed —
good sense pain relief 325 mg 68071-3883-02 NuCare 20 tablets — — FDA listed —
good sense pain relief 325 mg 68071-3917-06 NuCare 6 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 68071-4656-05 NuCare 50 tablets — — FDA listed —
DRX CHOICE Regular Strength 325 mg 68163-0065-60 Raritan 60 tablets — — FDA listed —
good sense pain relief 325 mg 68788-8821-01 Preferred 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 68998-0301-01 MARC 100 tablets — — FDA listed —
Acetaminophen 325mg RS 325 mg 69168-0010-30 Allegiant 30 tablets — — FDA listed —
Acetaminophen 325 Mg 69618-0010-01 Reliable 100 tablets — — FDA listed —
Acetaminophen 325 mg 69822-0692-10 Southern 325 tablets — — Discontinued —
Acetaminophen Regular Strength 325 mg 69842-0876-51 CVS 365 tablets — — FDA listed —
Acetaminophen 325 mg 69842-0968-01 CVS 100 tablets — — FDA listed —
Regular Strength Pain Reliever 325 mg 70677-1243-01 Strategic 120 tablets — — FDA listed —
MEDI-FIRST Non-Aspirin 325 mg 71205-0306-04 Proficient 4 tablets — — FDA listed —
Acetaminophen 325 Mg 71205-0456-00 Proficient 100 tablets — — FDA listed —
good sense pain relief 325 mg 71335-2574-01 Bryant 100 tablets — — FDA listed —
Acetaminophen 325 mg 71335-2747-00 Bryant 24 tablets — — FDA listed —
Acetaminophen 325 mg 71335-3130-00 Bryant 24 tablets — — FDA listed —
Acetaminophen 325 mg 71399-1025-01 Akron 100 tablets — — FDA listed —
Acetaminophen 325 mg 71610-0238-65 Aphena 100 tablets — — FDA listed —
Acetaminophen 325 mg 71679-0305-00 Health 47000 tablets — — FDA listed —
Acetaminophen 325 mg 72036-0100-02 HARRIS 100 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 72162-2252-01 Bryant 100 tablets — — FDA listed —
basic care acetaminophen 325 mg 72288-0403-78 Amazon.com 100 tablets — — FDA listed —
Amazon Basic Care Acetaminophen 325 mg 72288-0405-10 Amazon.com 100 tablets — — FDA listed —
Acetaminophen 325 mg 72789-0267-20 PD-Rx 20 tablets — — FDA listed —
Pharbetol 325 mg 73057-0353-08 Ulai 100 tablets — — FDA listed —
Aphen 325 mg 76420-0372-15 Asclemed 150 tablets — — FDA listed —
Pain Reliever 325 mg 79903-0130-99 WAL-MART 100 tablets — — FDA listed —
equate pain reliever 325 mg 79903-0299-10 WALMART 100 tablets — — FDA listed —
Dr Simi Pain Relief 325 mg 85786-0103-90 Farmacias 100 tablets — — FDA listed —
Acetaminophen 325 mg 85828-0102-02 Grocery 100 tablets — — FDA listed —
Acetaminophen 325 mg 69732-0002-01 Hi-Tech 30 tablets — — FDA listed —
Pain Relief Acetaminophen 325 mg 84324-0046-01 NUVICARE 300 tablets — — FDA listed —
Gencare- Pain Relief Acetaminophen 325 mg 72090-0069-01 Pioneer 1000 tablets — — FDA listed —
Medline 325 mg 53329-0199-09 Medline 100 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white
ShapeRound
ImprintA325
Size4 mm
ScoringScored — splits in 2
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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 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.

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

The official label also statesInactive Ingredients: Gelatinized starch, magnesium stearate, povidone

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.

Manufacturer & labeler

LabelerAARNA USA INC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code82568
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio19 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 ⚠️ Warnings 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses To reduce fever and for the temporary relief of minor aches and pains due to: •headache •muscular aches •backache •minor pain of arthritis •the common cold •toothache •premenstrual and menstrual cramps. •Temporarily reduces fever.

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product 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.

Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if the user has ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if the user has has liver disease is a child with pain of arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if: pain gets worse or lasts more than 10 days (for adults) or 5 days (for children) fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present.

These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🆘 Overdosage 95 words ▾

do not take more than directed (see overdose warning ) adults & children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor child under 6 years ask a doctor

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Acetaminophen 325 mg

🧪 Inactive Ingredients 7 words ▾

Inactive Ingredients: Gelatinized starch, magnesium stearate, povidone

🎯 Purpose 4 words ▾

Purpose Pain Reliever/Fever Reducer

📄 Other Information 10 words ▾

Other information store at 20° to 25°C (68° to 77°F)

📄 Questions or Comments 32 words ▾

Questions or comments? call toll-free 1-877-225-6999. Manufactured for: AARNA USA INC. Leland, NC-28451 * This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

📄 Package Label / Principal Display Panel 1 words ▾

1

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2026 – Q1 2026 · 1 quarter of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
85
Units reimbursed last 4 qtrs
6K
Gross reimbursed last 4 qtrs
$1.2K
Avg / prescription
$14.26
Avg / unit
$0.2033
Latest quarter Q1 2026
85Rx
Medicaid pays / ea
$0.2033
gross reimbursed
vs
NADAC / ea
$0.0233
acquisition cost
=
Spread
+$0.1800
+773% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 85 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 5,961 units · 15.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
15.315.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 15.3 /100k
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page82568-0001-01 85 Rx · $1,212
1000 tablets82568-0001-02 No Medicaid data
100 tablets82568-0001-03 No Medicaid data
Drug total (last 4 qtrs): 85 Rx · 5,961 units · $1,212 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 82564-0000-01 · S 82568-0002-01 · AARNA →
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.