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Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet, 18-count — NDC 70000-0622-1 (Billing 70000-0622-01)

by LEADER/ Cardinal Health 110, Inc. · 18 TABLET in 1 BOTTLE

This is a package of 18 tablets of Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet from LEADER/ Cardinal Health 110, Inc., marketed since Jul 2023 and currently FDA-listed; retail pharmacies pay about $0.1071 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 70000-0622-01
🏷️ FDA NDC (as labeled) 70000-0622-1 billing pads the package segment with a zero
This package
Contains18-count Cost per ea$0.1071 NADAC Per package$1.93 / 18 tablets Pack sizes2 compare ↓
Main listing for product 70000-0622 · Also comes in: 36 tablets 70000-0622-2
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0622-1
Product NDC 70000-0622
11-digit billing NDC 70000062201
NCPDP billing unit EA — each (per item)
RxCUI 2387532
UNII 362O9ITL9D, WK2XYI10QM
Application # ANDA216592
SPL Set ID f1d69088-4d52-cbb5-e053-2995a90a3ec8
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-15
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; IBUPROFEN

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

GCN Seq No 080857
GCN 47839
HICL code 012981
Ingredient (HICL) Ibuprofen/Acetaminophen
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2Y
Therapeutic class — specific (HIC3) Nsaid Analgesic And Non-Salicylate Analgesic Comb
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name DUAL ACTION PAIN 250-125 MG
FDB brand name Dual Action Pain Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 080857
  • GCN: 47839
  • HICL (First Databank): 012981
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 2387532
Why two NDCs? The FDA registers this code as 70000-0622-1 — a 5-4-1 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 package segment → 70000-0622-01. 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.

Clinical

Label name DUAL ACTION PAIN 250-125 MG Ingredient Ibuprofen/Acetaminophen
📗 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 →

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 eaPer package
Retail pharmacies payNADAC · weekly $0.107 $1.93 / 18 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.107 $0.084
▲ Up 16% over the last 10 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
70000-0622-01 You're viewing this Main listing 18 TABLET in 1 BOTTLE $0.1071 / ea $1.93 2023-07-15 — Active
70000-0622-02 70000-0622-2 36 TABLET in 1 BOTTLE — — 2023-07-15 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 18-count package — 18 tablet in 1 bottle.
How does this package differ from NDC 70000-0622-02?
Both are Acetaminophen and Ibuprofen 250 mg; 125 mg Tablet — the drug itself is identical. This page's package is the 18-count one, while NDC 70000-0622-02 is the 36 tablets package.
What NDC number is used to bill for this package of Acetaminophen and Ibuprofen 250 mg; 125 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
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 00536-1376-36 RUGBY 36 tablets $0.084 — Availability likely save 21%
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 mgthis 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 mg 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 —
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
Jul 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.

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

LabelerLEADER/ Cardinal Health 110, Inc.
Application holderGRANULES PHARMACEUTICALS INC
FDA applicationANDA216592 (ANDA)
Labeler code70000
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio38 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 📄 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 27 words ▾

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

⏱️ Dosage and Administration 49 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 ~1 min read ▾

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.

🆘 Overdosage 40 words ▾

Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 28 words ▾

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

🧪 Active Ingredient 15 words ▾

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

🧪 Inactive Ingredients 35 words ▾

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

🎯 Purpose 5 words ▾

Purposes Pain reliever Pain reliever

📄 Do Not Use 51 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 64 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 40 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 14 words ▾

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

📄 Stop Use and Ask a Doctor If 94 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 12 words ▾

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

📄 Questions or Comments 13 words ▾

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

📄 Package Label / Principal Display Panel 2 words ▾

36ct 18ct

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 — 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) ✓ Available
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 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 LEADER/ Cardinal Health 110, 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 36 tablets (70000-0622-02). 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?
LEADER/ Cardinal Health 110, 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.
← 70000-0618-01 · Cardinal 70000-0623-01 · Cardinal →
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.