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Acetaminophen 650 mg Tablet, 400-count — NDC 00904-7314-27 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen 650 mg Tablet, 400-count — NDC 0904-7314-27 (Billing 00904-7314-27)

by MAJOR PHARMACEUTICALS · 400 TABLET in 1 BOTTLE

This is a package of 400 tablets of Acetaminophen 650 mg Tablet from MAJOR PHARMACEUTICALS, marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.0631 per tablet (NADAC).

NDC 00904-7314-27
🏷️ FDA NDC (as labeled) 0904-7314-27 billing pads the labeler segment with a zero
This package
Contains400-count Cost per ea$0.0631 NADAC Per package$25.24 / 400 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1567/unit — full pricing hub ↓
Product page 00904-7314-60 Also comes in: 100 tablets 0904-7314-60
OTC Generic 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) 0904-7314-27
Product NDC 0904-7314
11-digit billing NDC 00904731427
NCPDP billing unit EA — each (per item)
RxCUI 1148399
UNII 362O9ITL9D
Application # ANDA211544
SPL Set ID efd0a432-abbb-1f88-e053-2995a90a8ce5
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-03
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN

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

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 ACETAMINOPHEN ER 650 MG CAPLET
FDB brand name Acetaminophen Er
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 022123
  • GCN: 16910
  • HICL (First Databank): 001866
  • AHFS class code: 28:08.16.00
  • RxCUI (RxNorm): 1148399
Why two NDCs? The FDA registers this code as 0904-7314-27 — a 4-4-2 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 labeler segment → 00904-7314-27. 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 ER 650 MG CAPLET Ingredient Acetaminophen
📗 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 $0.063 $25.24 / 400 tablets
Medicaid paysCMS SDUD · 12 mo $0.1567 $62.68 / 400 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
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.071 $0.063
▼ Down 11% over the last 13 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
00904-7314-27 You're viewing this 400 TABLET in 1 BOTTLE $0.0631 / ea $25.22 2023-03-03 — Active
00904-7314-60 0904-7314-60 Main listing 100 TABLET in 1 BOTTLE $0.0631 / ea $6.31 2023-03-03 — Active

You're viewing the largest of 2 pack sizes for this product.

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 56% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 400-count package — 400 tablet in 1 bottle.
How does this package differ from NDC 00904-7314-60?
Both are Acetaminophen 650 mg Tablet — the drug itself is identical. This page's package is the 400-count one, while NDC 00904-7314-60 is the 100 tablets package.
What NDC number is used to bill for this package of Acetaminophen 650 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
major acetaminophen 650 mg 00904-6883-65 Major 400 tablets $0.063 — Availability likely —
Acetaminophen 650 mgthis 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 +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 — — Discontinued —
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 —
NOTTS - Muscle Aches and Pain 650 mg 82706-0008-01 VIVUNT 24 tablets — — FDA listed —
Acetaminophen 650 mg 68196-0935-20 SAM'S 200 tablets — — FDA listed —
ATAMEL Forte 650 mg 69729-0800-24 OPMX 12 tablets — — FDA listed —
Acetaminophen 650mg 650 mg 81877-0850-30 Forreal 30 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color white
ShapeOval
ImprintG;650
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerMAJOR PHARMACEUTICALS
Application holderGRANULES INDIA LTD
FDA applicationANDA211544 (ANDA)
Labeler code00904
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio630 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 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 65 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 78 words ▾

Liver 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.

🆘 Overdosage 40 words ▾

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 19 words ▾

Other information ■ store between 20-25°C (68-77°F) ■ do not use if foil inner seal is broken or missing

🧪 Active Ingredient 9 words ▾

Active ingredient (in each caplet) Acetaminophen USP, 650 mg

🧪 Inactive Ingredients 19 words ▾

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

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

📄 Do Not Use 44 words ▾

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 10 words ▾

Ask a doctor before use if you have liver disease

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 Stop Use and Ask a Doctor If 45 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children Keep out of reach of children

📄 Questions or Comments 13 words ▾

Questions or comments? contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

📄 Package Label / Principal Display Panel 5 words ▾

PDP APAP 650mg 400ct 100ct

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 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
79.8K
Units reimbursed last 4 qtrs
6.4M
Gross reimbursed last 4 qtrs
$996.8K
Avg / prescription
$12.49
Avg / unit
$0.1567
Latest quarter Q1 2026
18.1KRx
Medicaid pays / ea
$0.1567
gross reimbursed
vs
NADAC / ea
$0.0631
acquisition cost
=
Spread
+$0.0936
+148% 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 ⓘ
74% FFS 26% MCO
Fee-for-service · 59,102 Rx Managed care · 20,714 Rx
State Medicaid map
Alaska: no data reported AK Maine: 14,287 units · 1,024 per 100k residents ME Washington: 64,724 units · 829 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 1,284 units · 164 per 100k residents ND Minnesota: 226,547 units · 3,949 per 100k residents MN Wisconsin: 209,257 units · 3,541 per 100k residents WI Michigan: 280,182 units · 2,791 per 100k residents MI New York: 3,090,506 units · 15,791 per 100k residents NY Vermont: 12,828 units · 1,983 per 100k residents VT New Hampshire: 14,661 units · 1,046 per 100k residents NH Oregon: 13,423 units · 317 per 100k residents OR Nevada: 34,393 units · 1,077 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 11,519 units · 168 per 100k residents IN Ohio: 85,424 units · 725 per 100k residents OH Pennsylvania: 369,007 units · 2,847 per 100k residents PA New Jersey: 198,284 units · 2,134 per 100k residents NJ Massachusetts: 72,906 units · 1,041 per 100k residents MA California: 1,080,976 units · 2,774 per 100k residents CA Utah: 10,802 units · 316 per 100k residents UT Colorado: 5,227 units · 88.9 per 100k residents CO Nebraska: 30,722 units · 1,553 per 100k residents NE Missouri: no data reported MO Kentucky: 78,794 units · 1,741 per 100k residents KY West Virginia: no data reported WV Virginia: 29,321 units · 336 per 100k residents VA Maryland: 14,933 units · 242 per 100k residents MD Connecticut: no data reported CT Rhode Island: 49,870 units · 4,554 per 100k residents RI Arizona: 37,000 units · 498 per 100k residents AZ New Mexico: no data reported NM Kansas: 32,857 units · 1,118 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 16,420 units · 306 per 100k residents SC Delaware: 3,856 units · 374 per 100k residents 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.: 41,614 units · 6,129 per 100k residents DC Hawaii: no data reported HI Texas: 227,661 units · 746 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
88.915,791
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 15,791 /100k
2 D.C. 6,129 /100k
3 Rhode Island 4,554 /100k
4 Minnesota 3,949 /100k
5 Wisconsin 3,541 /100k
6 Pennsylvania 2,847 /100k
7 Michigan 2,791 /100k
8 California 2,774 /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.
400 tablets this page00904-7314-27 79,816 Rx · $996,788
100 tablets00904-7314-60 61,879 Rx · $679,635
Drug total (last 4 qtrs): 141,695 Rx · 10,919,589 units · $1,676,422 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.
← 00904-7313-10 · Major 00904-7315-61 · Major →
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.