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8 Hour Pain Relief Acetaminophen 650 mg Tablet, Extended Release, 100-count — NDC 46122-0630-78 package photo

8 Hour Pain Relief Acetaminophen 650 mg Tablet, Extended Release, 100-count

by AMERISOURCE BERGEN · 1 BOTTLE, PLASTIC in 1 CARTON (46122-630-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
NDC 46122-0630-78
🏷️ FDA NDC (as labeled) 46122-630-78 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0631 NADAC Per package$6.31 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1634/unit — full pricing hub ↓
Also comes in: 50 tablets 46122-0630-71
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) 46122-630-78
Product NDC 46122-630
11-digit billing NDC 46122063078
NCPDP billing unit EA — each (per item)
RxCUI 1148399
UNII 362O9ITL9D
UPC 0087701432484
Application # ANDA211544
SPL Set ID 9ab903aa-7170-460b-9527-e3df223f5f55
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-13
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance ACETAMINOPHEN
GPI-14 64200010000420
GPI class GNP 8 Hour Pain Relief
GCN Seq No 022123
GCN 16910
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 GNP 8 HOUR PAIN RELIEF 650 MG
FDB brand name 8 Hour Pain Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-630-78 — 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 → 46122-0630-78. 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

LabelerAMERISOURCE BERGEN
Application holderGRANULES INDIA LTD
FDA applicationANDA211544 (ANDA)
Labeler code46122
First marketedJan 2020
Product typeHuman Otc Drug
Portfolio206 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GNP 8 HOUR PAIN RELIEF 650 MG 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
  • 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
ImprintG650
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 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 8136Y38GY5
    A plant-derived thickening agent made from cellulose. It increases the thickness and consistency of liquid medicines, helping them coat surfaces and flow smoothly.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also stateshydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

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 eaPer package
Retail pharmacies payNADAC · weekly $0.063 $6.31 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1634 $16.34 / 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 2022 Aug 2022 Jan 2026 Sep 2026 $0.071 $0.062
▼ Down 1% over the last 24 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.

🔁 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 mgthis 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 +10%
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 mg 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 —
Medline 650 mg 53329-0221-09 Medline 50 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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 years 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.

🗺️ 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 46122-0630-78, 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 2025 – Q1 2026 · 5 quarters 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
6.1K
Units reimbursed last 4 qtrs
486.7K
Gross reimbursed last 4 qtrs
$79.5K
Avg / prescription
$12.97
Avg / unit
$0.1634
Latest quarter Q1 2026
1.8KRx
Medicaid pays / ea
$0.1634
gross reimbursed
vs
NADAC / ea
$0.0631
acquisition cost
=
Spread
+$0.1003
+159% 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 ⓘ
76% FFS 24% MCO
Fee-for-service · 4,633 Rx Managed care · 1,498 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,970 units · 141 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 38,055 units · 663 per 100k residents MN Wisconsin: 6,145 units · 104 per 100k residents WI Michigan: 32,996 units · 329 per 100k residents MI New York: 189,280 units · 967 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,360 units · 55.8 per 100k residents 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: 14,835 units · 126 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 9,098 units · 97.9 per 100k residents NJ Massachusetts: 6,060 units · 86.6 per 100k residents MA California: 146,153 units · 375 per 100k residents CA Utah: no data reported UT Colorado: 180 units · 3.1 per 100k residents CO Nebraska: 7,210 units · 365 per 100k residents NE Missouri: no data reported MO Kentucky: 16,004 units · 354 per 100k residents KY West Virginia: 1,043 units · 58.9 per 100k residents WV Virginia: 11,720 units · 134 per 100k residents 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: 3,570 units · 249 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.1967
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 New York 967 /100k
2 Minnesota 663 /100k
3 California 375 /100k
4 Nebraska 365 /100k
5 Kentucky 354 /100k
6 Michigan 329 /100k
7 Hawaii 249 /100k
8 Maine 141 /100k
National units — by quarter
💵 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 page46122-0630-78 6,131 Rx · $79,522
50 tablets46122-0630-71 1,105 Rx · $15,607
Drug total (last 4 qtrs): 7,236 Rx · 557,840 units · $95,129 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 (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 8 Hour Pain Relief (this brand).

Top reported reactions

Fatigue20,901
Pain18,469
Nausea18,167
Headache17,127
Toxicity To Various Agents15,843
Dyspnoea15,012
Pyrexia14,579

Age at onset

Neonate562
Infant376
Child2,615
Adolescent2,132
Adult26,646
Elderly17,765

Reporter sex

253,624 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization114,315
Life-threatening21,902
Disabling12,025
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,614 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
46122-0630-78 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (46122-630-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC $0.0631 / ea $6.31 2020-01-13 Active
46122-0630-71 1 BOTTLE, PLASTIC in 1 PACKAGE (46122-630-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC $0.0631 / ea $3.15 2024-08-27 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0631 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 85% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 46122-0630-78?
NDC 46122-0630-78 is a 100-count package — 1 bottle, plastic in 1 carton / 100 tablet, extended release in 1 bottle, plastic.
What is the difference between NDC 46122-0630-78 and NDC 46122-0630-71?
Both are 8 Hour Pain Relief Acetaminophen 650 mg Tablet, Extended Release — the drug itself is identical. NDC 46122-0630-78 is the 100-count package, while NDC 46122-0630-71 is the 50 tablets package.
What NDC number is used to bill for this package of 8 Hour Pain Relief Acetaminophen 650 mg Tablet, Extended Release?
Bill NDC 46122-0630-78 — the 11-digit billing format is 46122063078. 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.

📄 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
🎯 Indications and Usage 28 words ▾

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

⏱️ Dosage and Administration 70 words ▾

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years do not use

⚠️ 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.

📦 Storage and Handling 14 words ▾

Other information store between 20-25°C (68-77°F) retain carton for complete product information and warnings

🧪 Active Ingredient 8 words ▾

Active ingredient (in each caplet) Acetaminophen 650 mg

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

🎯 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 ↗
← 46122-0629-71 · AMERISOURCE 46122-0632-62 · Amerisource →
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.