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Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet, Film Coated, 500-count — NDC 50844-0598-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet, Film Coated, 500-count — NDC 50844-598-14 (Billing 50844-0598-14)

by L.N.K. International, Inc. · 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 500 tablets of Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet, Film Coated from L.N.K. International, Inc., marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 50844-0598-14
🏷️ FDA NDC (as labeled) 50844-598-14 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Main listing for product 50844-598 · Also comes in: 8 tablets 50844-598-19
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 50844-598-14 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50844 labeler · 598 product · 14 package
Package marketed since
Sep 10, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5084459814 1
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Acetaminophen, Ibuprofen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0347-2025
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) 50844-598-14
Product NDC 50844-598
11-digit billing NDC 50844059814
Application # ANDA220126
SPL Set ID 339a32d8-e407-4c8d-8c19-8858d0e3959e
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; IBUPROFEN
Why two NDCs? The FDA registers this code as 50844-598-14 — 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 → 50844-0598-14. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

2
Nutrient depletion considerations

Acetaminophen, Ibuprofen may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Ibuprofen 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 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.
Try another pack size: 8 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50844-0598-14 You're viewing this Main listing 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2026-09-10 — Active
50844-0598-19 50844-598-19 1 BOTTLE, PLASTIC in 1 CARTON / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2026-09-10 — Active

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 50844-0598-19?
Both are Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 50844-0598-19 is the 8 tablets package.
What NDC number is used to bill for this package of Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet, Film Coated?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense dual action 250 mg/1; 125 mg 00113-5300-16 L 144 tablets $0.107 — Availability likely —
foster and thrive dual action 250 mg/1; 125 mg 70677-1274-01 Strategic 36 tablets $0.107 — Availability likely —
Leader Dual Action Pain Reliever 250 mg/1; 125 mg 70000-0737-01 Cardinal 18 tablets $0.107 — Availability likely —
Dual Action 250 mg/1; 125 mg 41226-0716-49 KROGER 144 tablets — — FDA listed —
Dual Action Pain Relief 250 mg/1; 125 mg 49483-0716-49 TIME 144 tablets — — FDA listed —
DG health dual pain reliever 250 mg/1; 125 mg 55910-0441-16 Dolgencorp 144 tablets — — FDA listed —
topcare dual action 250 mg/1; 125 mg 76162-0501-16 Topco 144 tablets — — FDA listed —
dual pain reliever 250 mg/1; 125 mg 79481-0503-00 Meijer, 36 tablets — — FDA listed —
equate pain reliever 250 mg/1; 125 mg 79903-0148-36 WALMART 36 tablets — — FDA listed —
dg health dual back pain reliever 250 mg/1; 125 mg 55910-0508-23 Dolgencorp 72 tablets — — FDA listed —
Good Sense Dual Action Back Pain 250 mg/1; 125 mg 00113-5299-16 L. 144 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 72288-0542-01 Amazon.com 216 tablets — — FDA listed —
dual action 250 mg/1; 125 mg 56062-0530-23 Publix 72 tablets — — FDA listed —
dual pain reliever 250 mg/1; 125 mg 00363-5220-01 Walgreen 216 tablets — — FDA listed —
Dual Back Pain Reliever 250 mg/1; 125 mg 00363-6199-23 Walgreen 72 tablets — — FDA listed —
Topcare Dual Action Back Pain 250 mg/1; 125 mg 76162-0520-23 Topco 72 tablets — — FDA listed —
equate dual back pain reliever 250 mg/1; 125 mg 79903-0326-72 WALMART 72 tablets — — FDA listed —
good sense dual action 250 mg/1; 125 mg 85766-0044-36 Sportpharm 36 tablets — — FDA listed —
acetaminophen and ibuprofen 250 mg/1; 125 mg 30142-0720-23 Kroger 72 tablets — — FDA listed —
Period Pills by Biikay 250 mg/1; 125 mg 85576-0101-36 Kai 36 tablets — — FDA listed —
Basic Care Dual Action 250 mg/1; 125 mg 72288-0530-01 Amazon.com 216 tablets — — FDA listed —
equate dual pain reliever 250 mg/1; 125 mg 79903-0243-36 WALMART 36 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 21130-0716-08 BETTER 18 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 42507-0540-72 HyVee 72 tablets — — FDA listed —
equaline dual action pain reliever 250 mg/1; 125 mg 41163-0103-68 United 36 tablets — — FDA listed —
Careone Dual Action 250 mg/1; 125 mg 72476-0231-23 Retail 72 tablets — — FDA listed —
dual action 250 mg/1; 125 mg 11822-5777-00 Rite 36 tablets — — FDA listed —
Pain Reliever 250 mg/1; 125 mg 69842-0675-23 CVS 72 tablets — — FDA listed —
Dual Action Back Pain Reliever 250 mg/1; 125 mg 79481-0152-00 Meijer, 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mgthis 50844-0598-14 L.N.K. 500 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 yellow
ShapeOval
Imprint44;798
Size15 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.
  • 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.

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

The official label also statescarnauba wax, corn starch, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerL.N.K. International, Inc.
Application holderLNK INTERNATIONAL INC
FDA applicationANDA220126 (ANDA)
Labeler code50844
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio64 products on file

More NDCs from L.N.K. International, Inc. labeler code 50844

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis

⏱️ Dosage and Administration 47 words ▾

Directions do not take more than directed adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor do not take more than 6 caplets in 24 hours, unless directed by a doctor

⚠️ Warnings ~3 min read ▾

Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 6 caplets in 24 hours, which is the maximum daily amount for this product 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away.

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 have ever had an allergic reaction to acetaminophen or any other pain reliever right before or after heart surgery Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 25 words ▾

Other information read all warnings and directions before use. store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) use by expiration date on package

🧪 Active Ingredient 15 words ▾

Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

🎯 Purpose 5 words ▾

Purposes Pain reliever Pain reliever

📄 Do Not Use 48 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 have ever had an allergic reaction to acetaminophen or any other pain reliever right before or after heart surgery

📄 Ask a Doctor Before Use If 58 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 37 words ▾

Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug

📄 When Using This Product 13 words ▾

When using this product take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 80 words ▾

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days redness or swelling is present in the painful area any new symptoms appear

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 43 words ▾

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

📄 Questions or Comments 10 words ▾

Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

📄 Package Label / Principal Display Panel 51 words ▾

Principal display panel QUALITY +PLUS NDC 50844- 598 -14 † Compare to active ingredients in Advil® Dual Action with Acetaminophen 8 HOUR RELIEF ACETAMINOPHEN and IBUPROFEN (NSAID) TABLETS 250 mg/125 mg PAIN RELIEVER 500 Caplets** **CAPSULE-SHAPED TABLETS ACTUAL SIZE CONTAINS 2 MEDICINES Acetaminophen + Ibuprofen Quality Plus 44-798 Quality Plus 44-798

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by L.N.K. International, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 8 tablets (50844-0598-19). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
L.N.K. International, 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.
← 50844-0572-02 · L.N.K. 50844-0600-32 · L.N.K. →
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.