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ADVIL DUAL ACTION WITH ACETAMINOPHEN Ibuprofen, 125 mg; 250 mg Tablet, Film Coated, 2-count — NDC 67751-0211-01 package photo

ADVIL DUAL ACTION WITH ACETAMINOPHEN Ibuprofen, 125 mg; 250 mg Tablet, Film Coated, 2-count

by Navajo Manufacturing Company Inc. · 1 POUCH in 1 CARTON (67751-211-01) / 2 TABLET, FILM COATED in 1 POUCH
NDC 67751-0211-01
🏷️ FDA NDC (as labeled) 67751-211-01 billing pads the product segment with a zero
This package
Contains2-count Pack sizes2 compare ↓
Also comes in: 2 tablets 67751-0211-02
OTC Brand On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 67751-211-01
Product NDC 67751-211
11-digit billing NDC 67751021101
RxCUI 2387532
UNII WK2XYI10QM, 362O9ITL9D
Application # NDA211733
SPL Set ID bd0d7812-4e42-b533-e053-2995a90ae1f9
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-21
Route ORAL
Dosage form TABLET, FILM COATED
Substance IBUPROFEN; ACETAMINOPHEN
Why two NDCs? The FDA registers this code as 67751-211-01 — 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 → 67751-0211-01. 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

LabelerNavajo Manufacturing Company Inc.
Application holderHALEON US HOLDINGS LLC
FDA applicationNDA211733 (NDA)
Labeler code67751
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio60 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

📗 Our plain-language guide HelloPharmacist
  • Great question — it's intentional. Acetaminophen and ibuprofen work through completely different pathways in the body, so together they can give you broader, more effective pain re...
  • Why does this combine two pain relievers? Is that safe?
  • It depends on what you're taking. The ibuprofen in this product can interact with blood thinners like warfarin, blood pressure medicines like ACE inhibitors or ARBs, diuretics, dig...
  • Can I take this with my other medications?
📖 Read our full Acetaminophen / Ibuprofen guide →
2
Nutrient depletion considerations

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

🧪 Full Ibuprofen, 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 yellow
ShapeOval
ImprintAdvil;II
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 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 R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • 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 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 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 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.

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

The official label also statesInactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, 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.

💲 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: 2 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 00536-1376-36 RUGBY 36 tablets $0.084 — Availability likely —
good sense dual action 250 mg/1; 125 mg 00113-5300-16 L 144 tablets $0.107 — Availability likely —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 46122-0742-68 AMERISOURCE 36 tablets $0.107 — Availability likely —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 46122-0818-61 AMERISOURCE 80 tablets $0.107 — Availability likely —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 70000-0622-01 LEADER/ 18 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 —
foster and thrive dual action 250 mg/1; 125 mg 70677-1274-01 Strategic 36 tablets $0.107 — Availability likely —
dual action pain reliever 125 mg/1; 250 mg 83324-0149-36 CHAIN 36 tablets $0.107 — Availability likely —
Good Sense Dual Action Back Pain 250 mg/1; 125 mg 00113-5299-16 L. 144 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 00363-4081-78 WALGREEN 80 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 —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 00363-9131-16 WALGREENS 216 tablets — — FDA listed —
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain 125 mg/1; 250 mg 00573-0145-02 Haleon 2 tablets — — FDA listed —
Advil Dual Action With Acetaminophen 125 mg/1; 250 mg 00573-0147-18 Haleon 18 tablets — — FDA listed —
Dual Action Pain Relief 125 mg/1; 250 mg 11673-0924-75 TARGET 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen (NSAID) 125 mg/1; 250 mg 11822-1131-04 RITE 144 tablets — — FDA listed —
dual action 250 mg/1; 125 mg 11822-5777-00 Rite 36 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 21130-0716-08 BETTER 18 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 250 mg/1; 125 mg 25000-0080-07 MARKSANS 90 tablets — — FDA listed —
acetaminophen and ibuprofen 250 mg/1; 125 mg 30142-0720-23 Kroger 72 tablets — — FDA listed —
equaline dual action pain reliever 250 mg/1; 125 mg 41163-0103-68 United 36 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 41226-0716-49 KROGER 144 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 42507-0540-72 HyVee 72 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 125 mg/1; 250 mg 43598-0052-05 Dr. 500 tablets — — FDA listed —
Dual Action Pain Relief 250 mg/1; 125 mg 49483-0716-49 TIME 144 tablets — — FDA listed —
Motrin Dual Action With Tylenol 125 mg/1; 250 mg 50580-0208-02 Kenvue 20 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 51316-0131-36 CVS 36 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 51316-0132-72 CVS 72 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 250 mg/1; 125 mg 51672-4258-01 Sun 216 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 53943-0034-76 DISCOUNT 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 55319-0139-36 Family 36 tablets — — FDA listed —
DG health dual pain reliever 250 mg/1; 125 mg 55910-0441-16 Dolgencorp 144 tablets — — FDA listed —
dg health dual back pain reliever 250 mg/1; 125 mg 55910-0508-23 Dolgencorp 72 tablets — — FDA listed —
dual action 250 mg/1; 125 mg 56062-0530-23 Publix 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 58602-0893-01 Aurohealth 24 tablets — — FDA listed —
Acetaminophen and Ibuprofen Back Pain 250 mg/1; 125 mg 58602-0895-01 Aurohealth 24 tablets — — FDA listed —
Advil Dual Action with Acetaminophen, Travel BASIX 125 mg/1; 250 mg 66715-6401-02 Lil' 2 tablets — — FDA listed —
Advil Dual Action with Acetaminophen 125 mg/1; 250 mg 66715-9601-03 Lil' 2 tablets — — FDA listed —
Advil Dual Action With Acetaminophen 125 mg/1; 250 mgthis 67751-0211-01 Navajo 2 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 69452-0394-64 Bionpharma 216 tablets — — FDA listed —
dual action pain reliever 125 mg/1; 250 mg 69452-0446-23 Bionpharma 144 tablets — — FDA listed —
dual action pain reliever 125 mg/1; 250 mg 69452-0447-22 Bionpharma 120 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 69452-0469-22 BIONPHARMA 120 tablets — — FDA listed —
Pain Reliever 250 mg/1; 125 mg 69842-0675-23 CVS 72 tablets — — FDA listed —
Aacetaminophen and Ibuprofen 250 mg/1; 125 mg 69848-0588-72 GRANULES 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 70010-0131-26 Granules 18 tablets — — FDA listed —
Acetaminophen and Ibuprofen Back Pain 250 mg/1; 125 mg 70010-0213-26 Granules 18 tablets — — FDA listed —
Acetaminophen 250 mg/1; 125 mg 70038-0131-36 RAONBIO 36 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 250 mg/1; 125 mg 70264-0040-12 R 2 tablets — — FDA listed —
Basic Care Dual Action 250 mg/1; 125 mg 72288-0530-01 Amazon.com 216 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 72288-0542-01 Amazon.com 216 tablets — — FDA listed —
Acetaminophen and Ibuprofen (NSAID) 125 mg/1; 250 mg 72476-0131-72 RETAIL 72 tablets — — FDA listed —
Careone Dual Action 250 mg/1; 125 mg 72476-0231-23 Retail 72 tablets — — FDA listed —
Acetaminophen, Ibuprofen 125 mg/1; 250 mg 72657-0157-05 GLENMARK 500 tablets — — FDA listed —
Dual Action 125 mg/1; 250 mg 75907-0158-14 Dr. 144 tablets — — FDA listed —
topcare dual action 250 mg/1; 125 mg 76162-0501-16 Topco 144 tablets — — FDA listed —
Topcare Dual Action Back Pain 250 mg/1; 125 mg 76162-0520-23 Topco 72 tablets — — FDA listed —
Dual Action Back Pain Reliever 250 mg/1; 125 mg 79481-0152-00 Meijer, 72 tablets — — FDA listed —
dual pain reliever 250 mg/1; 125 mg 79481-0503-00 Meijer, 36 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 79481-6501-07 Meijer 80 tablets — — FDA listed —
equate pain reliever 250 mg/1; 125 mg 79903-0148-36 WALMART 36 tablets — — FDA listed —
equate dual pain reliever 250 mg/1; 125 mg 79903-0243-36 WALMART 36 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 79903-0244-44 WAL-MART 144 tablets — — FDA listed —
equate dual back pain reliever 250 mg/1; 125 mg 79903-0326-72 WALMART 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen (NSAID) 125 mg/1; 250 mg 79903-0931-44 Wal-Mart 144 tablets — — FDA listed —
dual action pain reliever 125 mg/1; 250 mg 83324-0178-44 CHAIN 144 tablets — — FDA listed —
Period Pills by Biikay 250 mg/1; 125 mg 85576-0101-36 Kai 36 tablets — — FDA listed —
good sense dual action 250 mg/1; 125 mg 85766-0044-36 Sportpharm 36 tablets — — FDA listed —
Advil Dual Action With Acetaminophen 125 mg/1; 250 mg 85237-1886-01 Select 2 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
First FDA approval
Feb 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 28, 2020 RLD RS ⏳ ~14.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11918693 — drug product
2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 11918693 ↗ Drug product — Jul 9, 2041
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🔬 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 Ibuprofen, Acetaminophen — the ingredient across all brands.

Top reported reactions

Drug Effective For Unapproved Indication1,591
Drug Effect Less Than Expected147
Therapeutic Product Effect Incomplete135
Therapeutic Response Unexpected90
Drug Ineffective For Unapproved Indication87
Abdominal Discomfort46
Abdominal Pain Upper29

Age at onset

Adult30
Elderly7

Reporter sex

0 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization12
Life-threatening5
Death2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 400 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 Marketing startStatus
67751-0211-01 You're viewing this 1 POUCH in 1 CARTON (67751-211-01) / 2 TABLET, FILM COATED in 1 POUCH 2021-05-21 Active
67751-0211-02 2 POUCH in 1 CARTON (67751-211-02) / 2 TABLET, FILM COATED in 1 POUCH 2021-05-21 Active

Pack size FAQ

What quantity is in NDC 67751-0211-01?
NDC 67751-0211-01 is a 2-count package — 1 pouch in 1 carton / 2 tablet, film coated in 1 pouch.
What NDC number is used to bill for this package of ADVIL DUAL ACTION WITH ACETAMINOPHEN Ibuprofen, 125 mg; 250 mg Tablet, Film Coated?
Bill NDC 67751-0211-01 — the 11-digit billing format is 67751021101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 67751-211-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 67751-0211-01, written without dashes as 67751021101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 67751-0211-01, the first segment (67751) is the labeler code FDA assigned to Navajo Manufacturing Company Inc.; the middle segment (0211) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Navajo Manufacturing Company 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 2 tablets (67751-0211-02). 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?
Navajo Manufacturing Company Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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 45 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 ~2 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 during the last 3 months of 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.

📦 Storage and Handling 21 words ▾

Other information read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

🧪 Active Ingredient 21 words ▾

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

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide

🎯 Purpose 21 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67751-0202-01 · Navajo 67751-0214-01 · Navajo →
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.