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Arthritis Pain Acetaminophen 650 mg Tablet, Extended Release, 200-count — NDC 68196-0034-02 package photo

Arthritis Pain Acetaminophen 650 mg Tablet, Extended Release, 200-count

by SAM'S WEST INC · 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (68196-034-02)
NDC 68196-0034-02
🏷️ FDA NDC (as labeled) 68196-034-02 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 68196-034-02
Product NDC 68196-034
11-digit billing NDC 68196003402
RxCUI 1148399
UNII 362O9ITL9D
Application # ANDA215486
SPL Set ID 3928090d-b45e-6948-e063-6394a90a47dd
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-20
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance ACETAMINOPHEN
Why two NDCs? The FDA registers this code as 68196-034-02 — 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 → 68196-0034-02. 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.

🏭 Manufacturer & labeler

LabelerSAM'S WEST INC
Application holderMARKSANS PHARMA LTD
FDA applicationANDA215486 (ANDA)
Labeler code68196
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio58 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 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
  • Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
  • What is acetaminophen actually used for?
  • That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
  • How much is too much? I'm worried about taking it too often.
📖 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.

💊 What it looks like

Color white
ShapeCapsule
Imprint71
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statescarnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
major acetaminophen 650 mg 00904-6883-65 Major 400 tablets $0.063 — Availability likely —
Acetaminophen 650 mg 00904-7314-27 MAJOR 400 tablets $0.063 — Availability likely —
8hr arthritis pain relief 650 mg 00904-7561-60 Major 100 tablets $0.063 — Availability likely —
8 Hour Arthritis Pain 650 mg 46122-0629-71 AMERISOURCE 50 tablets $0.063 — Availability likely —
8 Hour Pain Relief 650 mg 46122-0630-78 AMERISOURCE 100 tablets $0.063 — Availability likely —
Acetaminophen 650 mg 49483-0699-01 TIME 100 tablets $0.063 — Availability likely —
Acetaminophen 650 mg 60687-0924-21 American 30 tablets $0.063 — Availability likely —
Acetaminophen 650 mg 68001-0495-00 BluePoint 100 tablets $0.063 — Availability likely —
8HR Arthritis Pain Relief 650 mg 70000-0733-01 LEADER/ 100 tablets $0.063 — Availability likely —
8HR Muscle Aches and Pain Relief 650 mg 70000-0734-01 LEADER/ 100 tablets $0.063 — Availability likely —
Acetaminophen 650 mg 70010-0160-01 Granules 100 tablets $0.063 — Availability likely —
8 Hour Pain Relief 650 mg 70677-1123-01 STRATEGIC 100 tablets $0.063 — Availability likely —
8 Hour Pain Relief 650 mg 83324-0082-50 CHAIN 50 tablets $0.063 — Availability likely —
good sense pain relief arthritis pain 650 mg 00113-0544-62 L. 24 tablets $0.069 — Discontinued —
Good Sense Pain Relief 650 mg 00113-0044-71 L. 50 tablets — — Discontinued —
Midol Long Lasting Relief 650 mg 00280-8090-20 Bayer 20 tablets — — FDA listed —
Acetaminophen 650 mg 00363-0340-08 Walgreen 80 tablets — — FDA listed —
arthritis pain reliever 650 mg 00363-0544-62 Walgreen 24 tablets — — Discontinued —
Acetaminophen 650 mg 00363-0892-04 Walgreens 20 tablets — — FDA listed —
Acetaminophen 650 mg 00363-9604-07 WALGREEN 24 tablets — — FDA listed —
Arthritis Pain Reliever 650 mg 00363-9781-01 WALGREENS 100 tablets — — FDA listed —
Acetaminophen 650 mg 00363-9992-10 WALGREENS 100 tablets — — FDA listed —
Acetaminophen 650 mg 00363-9993-15 WALGREENS 150 tablets — — FDA listed —
Acetaminophen 650 mg 00615-8624-39 NCS 30 tablets — — FDA listed —
Arthritis Pain Acetaminophen 650 mg 11673-0673-01 TARGET 100 tablets — — FDA listed —
8HR Pain Relief 650 mg 11673-0928-01 TARGET 100 tablets — — FDA listed —
Acetaminophen 650 mg 11822-5019-02 RITE 100 tablets — — FDA listed —
Acetaminophen 650 mg 11822-5091-04 RITE 100 tablets — — FDA listed —
Arthritis Pain 650 mg 21130-0097-01 BETTER 100 tablets — — FDA listed —
Acetaminophen 650 mg 21130-0108-07 Better 24 tablets — — FDA listed —
Acetaminophen Extended-Release Tablets, 650 mg 25000-0071-02 MARKSANS 24 tablets — — FDA listed —
Acetaminophen Extended-Release Tablets, 650 mg 25000-0108-02 MARKSANS 24 tablets — — FDA listed —
Acetaminophen 650 mg 30142-0157-07 KROGER 24 tablets — — FDA listed —
Topcare 8 Hour Pain Relief 650 mg 36800-0369-78 Topco 100 tablets — — FDA listed —
topcare 8 hr arthritis pain relief 650 mg 36800-0455-62 Topco 24 tablets — — Discontinued —
Arthritis Pain Relief 650 mg 36800-0632-01 TOPCO 24 tablets — — FDA listed —
topcare 8 hr arthritis pain relief 650 mg 36800-0779-47 Topco 150 tablets — — FDA listed —
Heb 650 mg 37808-0120-02 HEB 50 tablets — — FDA listed —
Pain Relief 8 HR 650 mg 37808-0747-71 H 50 tablets — — FDA listed —
Acetaminophen 650 mg 37835-0512-01 Bi-Mart 100 tablets — — FDA listed —
eight hour pain relief 650 mg 41163-0203-02 United 50 tablets — — FDA listed —
Arthritis Pain Relief 650 mg 41226-0699-01 KROGER 100 tablets — — FDA listed —
8 Hour Pain Relief 650 mg 41226-0704-01 KROGER 100 tablets — — FDA listed —
arthritis pain relief 650 mg 41250-0658-03 Meijer 100 tablets — — FDA listed —
Pain Relief 650 mg 41250-0802-62 Meijer 24 tablets — — FDA listed —
arthritis pain relief 650 mg 41250-0966-47 Meijer 150 tablets — — FDA listed —
CareOne 8 Hour Pain Relief 650 mg 41520-0127-71 American 50 tablets — — Discontinued —
Care One arthritis pain relief 650 mg 41520-0544-71 American 50 tablets — — FDA listed —
Arthritis Pain 650 mg 42507-0205-01 HYVEE 24 tablets — — FDA listed —
Pain Relief 650 mg 42507-0303-03 HYVEE 100 tablets — — FDA listed —
Good Neighbor Pharmacy Menstrual Pain Relief 650 mg 46122-0836-70 Amerisource 20 tablets — — FDA listed —
Acetaminophen 650 mg 49035-0181-21 WAL-MART 225 tablets — — FDA listed —
Equate 8HR Arthritis Pain Relief 650 mg 49035-0741-62 Wal-Mart 24 tablets — — FDA listed —
Muscle Aches and Pains Acetaminophen extended release 650 mg 49483-0704-05 TIME 50 tablets — — FDA listed —
Tylenol 8HR 650 mg 50580-0309-01 Kenvue 24 tablets — — FDA listed —
Tylenol 8 Hr Arthritis Pain 650 mg 50580-0575-01 Kenvue 24 tablets — — FDA listed —
Tylenol 8 Hr Muscle Aches And Pain 650 mg 50580-0576-01 Kenvue 24 tablets — — FDA listed —
Tylenol 8 HR Arthritis Pain 650 mg 50580-0783-10 Kenvue 100 tablets — — FDA listed —
8 Hr Muscle Aches And Pain 650 mg 51316-0354-42 CVS 24 tablets — — FDA listed —
8 hr arthritis pain 650 mg 51316-0504-79 CVS 400 tablets — — FDA listed —
8HR Arthritis Pain Relief 650 mg 51316-0969-01 CVS 100 tablets — — FDA listed —
Acetaminophen 650 mg 53329-0643-29 Medline 50 tablets — — FDA listed —
Arthritis Pain 650 mg 53943-0200-02 DISCOUNT 50 tablets — — FDA listed —
Acetaminophen Extended-Release 650 mg 54257-0573-03 Magno-Humphries, 200 tablets — — FDA listed —
Acetaminophen 650 mg 55319-0185-10 FAMILY 100 tablets — — FDA listed —
DG Health 8 Hour Pain Relief 650 mg 55910-0749-71 Dolgencorp 50 tablets — — FDA listed —
dg health 8 hr arthritis pain relief 650 mg 55910-0828-62 Dolgencorp 24 tablets — — FDA listed —
8 hr Arthritis Pain Relief 650 mg 55910-0892-05 DOLGENCORP, 50 tablets — — FDA listed —
8 hr Pain Relief 650 mg 55910-0895-05 DOLGENCORP, 50 tablets — — FDA listed —
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg 55959-0179-03 BENARD 30 tablets — — FDA listed —
arthritis pain relief 650 mg 56062-0544-62 Publix 24 tablets — — FDA listed —
Arthritis Pain 650 mg 57344-0200-02 AAA 50 tablets — — FDA listed —
8HR Muscle Aches and Pain 650 mg 57344-0201-03 AAA 100 tablets — — FDA listed —
Acetaminophen 650 mg 57896-0268-01 GERI-CARE 100 tablets — — FDA listed —
Acetaminophen 650 mg 58602-0730-07 Aurohealth 24 tablets — — FDA listed —
Acetaminophen 650 mg 58602-0848-21 Aurohealth 100 tablets — — Discontinued —
Acetaminophen 650 mg 58602-0873-07 Aurohealth 24 tablets — — FDA listed —
Arthritis Pain 650 mg 61504-0200-03 AMERIFOODS 100 tablets — — FDA listed —
Acetaminophen 650 mg 62207-0183-34 Granules 5 tablets — — FDA listed —
Acetaminophen 650 mg 62207-0188-49 Granules 1000 tablets — — FDA listed —
Acetaminophen 650 mg 62207-0892-49 Granules 1000 tablets — — FDA listed —
Acetaminophen 650 mg 63868-0660-01 CHAIN 100 tablets — — FDA listed —
8 Hour Pain Relief 650 mg 63868-0679-50 CHAIN 50 tablets — — FDA listed —
8 Hour Arthritis Pain 650 mg 63941-0300-02 VALU 50 tablets — — FDA listed —
8 Hour Pain Relief 650 mg 63941-0401-02 VALU 50 tablets — — FDA listed —
Arthritis Pain Relief 650 mg 67091-0401-02 WINCO 50 tablets — — FDA listed —
Arthritis Pain Relief 650 mg 68016-0303-01 CHAIN 100 tablets — — FDA listed —
Arthritis Pain 650 mgthis 68196-0034-02 SAM'S 200 tablets — — FDA listed —
Members Mark Arthritis Pain 650 mg 68196-0611-82 Sam's 200 tablets — — FDA listed —
8 Hour Arthritis Pain 650 mg 68998-0401-03 MARC 100 tablets — — FDA listed —
Pain Relief 650 mg 69168-0461-03 Allegiant 250 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0037-35 CVS 225 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0297-10 CVS 100 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0322-10 CVS 100 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0635-07 CVS 24 tablets — — FDA listed —
Acetaminophen 650 mg 69842-0930-80 CVS 80 tablets — — FDA listed —
Acetaminophen 650 mg 69848-0015-10 Granules 100 tablets — — FDA listed —
Acetaminophen 650 mg 70000-0626-01 LEADER/ 100 tablets — — FDA listed —
Acetaminophen 650 mg 70000-0627-01 LEADER/ 50 tablets — — FDA listed —
Leader 8HR Arthritis Pain Relief 650 mg 70000-0736-01 Cardinal 225 tablets — — FDA listed —
Acetaminophen 650 mg 71335-1340-01 Bryant 30 tablets — — FDA listed —
good sense pain relief arthritis pain 650 mg 71335-2545-01 Bryant 30 tablets — — FDA listed —
Acetaminophen 650 mg 71335-9746-01 Bryant 30 tablets — — FDA listed —
8HR Arthritis Pain 650 mg 72036-0200-04 HARRIS 100 tablets — — FDA listed —
basic care acetaminophen 650 mg 72288-0544-79 Amazon.com 400 tablets — — FDA listed —
basic care acetaminophen 650 mg 72288-0634-78 Amazon.com 100 tablets — — FDA listed —
Amazon Basic Care Acetaminophen 650 mg 72288-0698-10 Amazon.com 100 tablets — — FDA listed —
Acetaminophen 650 mg 72476-0185-05 RETAIL 50 tablets — — FDA listed —
Acetaminophen 650 mg 72476-0186-05 RETAIL 50 tablets — — FDA listed —
good sense pain relief arthritis pain 650 mg 76420-0590-01 ASCLEMED 100 tablets — — FDA listed —
Acetaminophen 650 mg 76420-0914-01 Asclemed 100 tablets — — FDA listed —
Acetaminophen 650 mg 79481-0183-02 MEIJER 225 tablets — — FDA listed —
Acetaminophen 650 mg 79481-0184-01 MEIJER, 100 tablets — — FDA listed —
Acetaminophen 650 mg 79903-0132-25 WALMART 325 tablets — — FDA listed —
Acetaminophen 650 mg 79903-0137-24 WAL-MART 24 tablets — — FDA listed —
equate 8hr arthritis pain relief 650 mg 79903-0345-33 WALMART 325 tablets — — FDA listed —
Equate Menstrual Pain Relief 650 mg 79903-0420-20 WALMART 20 tablets — — FDA listed —
8HR Arthritis Pain 650 mg 81522-0200-03 FSA 100 tablets — — FDA listed —
8HR Muscle Aches and Pain 650 mg 81522-0201-03 FSA 100 tablets — — FDA listed —
8 Hour Arthritis Pain 650 mg 83324-0083-01 CHAIN 100 tablets — — FDA listed —
Arthritis Pain 650 mg 85828-0200-01 Grocery 24 tablets — — FDA listed —
8 HR Arthritis Pain 650 mg 75907-0430-01 Dr. 100 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

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

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — 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.

🔬 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 Diclofenac sodium topical gel, 1% — the ingredient across all brands.

Top reported reactions

Pain7,446
Fatigue7,029
Rheumatoid Arthritis6,412
Rash6,133
Abdominal Discomfort6,038
Systemic Lupus Erythematosus5,897
Alopecia5,795

Reporter sex

35,580 reports

Serious outcomes

Disabling7,224
Death6,895
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,912 1,760
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68196-0034-02 You're viewing this 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (68196-034-02) 2025-08-20 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68196-034-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68196-0034-02, written without dashes as 68196003402. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68196-0034-02, the first segment (68196) is the labeler code FDA assigned to SAM'S WEST INC; the middle segment (0034) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SAM'S WEST INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SAM'S WEST INC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🤰 Pregnancy 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

⏱️ Dosage and Administration 59 words ▾

Directions Do not take more than directed. See overdose warning. adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split, or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days 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: 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.

🤰 Pregnancy 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📦 Storage and Handling 14 words ▾

Other information store between 20-25ºC (68-77ºF) The FDA approved dissolution methods differ from USP

🧪 Active Ingredient 8 words ▾

Active ingredient (in each caplet) Acetaminophen 650 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68196-0033-56 · SAM'S 68196-0045-03 · Sam's →
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.