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KORTRIBION Pain Reliever Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated — NDC 69729-793-24 (Billing 69729-0793-24)

by OPMX LLC · 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of KORTRIBION Pain Reliever Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated from OPMX LLC, marketed since Feb 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69729-0793-24
🏷️ FDA NDC (as labeled) 69729-793-24 billing pads the product segment with a zero
This package
Contains12 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Main listing for product 69729-793 · Also comes in: 4 tablets 69729-793-80
OTC 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 69729-793-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69729 labeler · 793 product · 24 package
Package marketed since
Feb 14, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6972979324 3
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69729-793-24
Product NDC 69729-793
11-digit billing NDC 69729079324
Application # M013
SPL Set ID 5c3fa9d9-74d1-9c75-e063-6294a90a5dd0
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; CAFFEINE
Why two NDCs? The FDA registers this code as 69729-793-24 — 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 → 69729-0793-24. 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

🧪 What is this product?

Kortribion Pain Reliever is an over-the-counter film-coated tablet taken by mouth. It contains acetaminophen, typically used to relieve minor aches, pains, and fever, and caffeine, a stimulant commonly added to pain relievers to increase alertness and enhance their effects. This combination product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual product approval.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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: 4 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
69729-0793-24 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK 2025-02-14 — Active
69729-0793-80 69729-793-80 20 POUCH in 1 CARTON / 4 TABLET, FILM COATED in 1 POUCH 2025-02-14 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 12 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of KORTRIBION Pain Reliever Acetaminophen, Caffeine 500 mg; 65 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
Tension Headache 500 mg/1; 65 mg 70000-0159-01 Cardinal 24 tablets $0.062 — Availability likely —
Excedrin Tension Headache 500 mg/1; 65 mg 00067-8139-01 Haleon 24 tablets — — FDA listed —
PANADOL Extra 500 mg/1; 65 mg 00135-0620-01 Haleon 24 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 00363-0572-31 Walgreen 80 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 00363-7213-10 WALGREENS 100 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 11673-0839-01 TARGET 100 tablets — — FDA listed —
Tension Headache Aspirin-Free 500 mg/1; 65 mg 11822-0428-02 Rite 100 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 49483-0373-01 TIME 100 tablets — — FDA listed —
DoloDent Toothache For adults 65 mg/1; 500 mg 55758-0435-24 Pharmadel 24 tablets — — FDA listed —
Tension Headache Aspirin Free 500 mg/1; 65 mg 59779-0824-06 CVS 200 tablets — — FDA listed —
DRX CHOICE Tension Headache 500 mg/1; 65 mg 68163-0506-15 Raritan 15 tablets — — FDA listed —
Sed-Max 500 mg/1; 65 mg 69197-0029-20 Command 20 tablets — — FDA listed —
Cafizetamol Forte 500 mg/1; 65 mg 69729-0147-40 OPMX 40 tablets — — FDA listed —
Migrafein FORTE 500 mg/1; 65 mg 69729-0148-40 OPMX 40 tablets — — FDA listed —
Neo-Lubrina Fuerte 500 mg/1; 65 mg 69729-0149-24 OPMX 12 tablets — — FDA listed —
Mejoral 500 mg/1; 65 mg 69729-0154-24 OPMX 12 tablets — — FDA listed —
KORTRIBION Pain Reliever 500 mg/1; 65 mgthis 69729-0793-24 OPMX 12 tablets — — FDA listed —
Doloneuro-Tropas 500 mg/1; 65 mg 69729-0795-80 OPMX 4 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 69732-0007-01 Hi-Tech 100 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 72090-0004-02 Pioneer 200 tablets — — FDA listed —
Tension Headache Pain Relieving Aid 500 mg/1; 65 mg 79903-0373-01 WAL-MART 100 tablets — — FDA listed —
NOTTS - Tension Headache 500 mg/1; 65 mg 82706-0010-01 VIVUNT 24 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 84324-0002-01 NUVICARE 100 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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

LabelerOPMX LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69729
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio87 products on file

More NDCs from OPMX LLC labeler code 69729

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

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 Acetaminophen, Caffeine — the ingredient across all brands.

Top reported reactions

Headache742
Pain627
Nausea581
Fatigue535
Fall391
Migraine359
Constipation354

Age at onset

Neonate2
Infant3
Child10
Adolescent29
Adult516
Elderly290

Reporter sex

9,017 reports
Male · 20%
Female · 80%
Unknown · 0%

Serious outcomes

Hospitalization1,382
Death249
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 506 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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 OPMX LLC. 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 4 tablets (69729-0793-80). 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?
OPMX LLC 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.
← 69729-0791-14 · OPMX 69729-0794-02 · OPMX →
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.