Chewable Acetaminophen Childrens 160 mg Tablet, Chewable, 24-count
by Cardinal Health 110, LLC. DBA Leader · 1 BOTTLE, PLASTIC in 1 CARTON (70000-0309-1) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
NDC 70000-0309-01
🏷️ FDA NDC (as labeled)
70000-0309-1
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
70000-0309-1
Product NDC
70000-0309
11-digit billing NDC
70000030901
NCPDP billing unit
EA — each (per item)
RxCUI
313820
UNII
362O9ITL9D
UPC
0096295132243
Application #
M013
SPL Set ID
8a18565c-b84e-43f8-8e96-e1dbcc39f08b
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2005-01-28
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
ACETAMINOPHEN
GPI-14
64200010000515
GPI class
Acetaminophen
GCN Seq No
004493
GCN
16970
HICL code
001866
Ingredient (HICL)
Acetaminophen
HIC1 code
H
Therapeutic class — broad (HIC1)
Nervous System (Except Autonomic)
HIC2 code
H3
Therapeutic class — intermediate (HIC2)
Analgesics
HIC3 code
H3E
Therapeutic class — specific (HIC3)
Analgesic/Antipyretics,Non-Salicylate
AHFS code
28:08.16.00
AHFS class
Non-Opioid Analgesics
FDB label name
CHILD ACETAMINOPHEN 160 MG
FDB brand name
Children's Acetaminophen
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0309-1 — 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 → 70000-0309-01. 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
LabelerCardinal Health 110, LLC. DBA Leader
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2005
Product typeHuman Otc Drug
Portfolio163 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
Label name CHILD ACETAMINOPHEN 160 MG Ingredient Acetaminophen
📖 What it is MedlinePlus · NLM
Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
- What is acetaminophen actually used for?
- That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
- How much is too much? I'm worried about taking it too often.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acetaminophen — tap one for details:
1
Nutrient depletion considerations
Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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.
💬 Questions about Acetaminophen?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
purple
ShapeRound
Imprint44;449
Size16 mm
ScoringScored — splits in 2
FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.116 | $2.79 / 24 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3468 | $8.32 / 24 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 3% over the last 24 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| childrens mapap 160 mg 00904-6645-24 | Major | 6 tablets | $0.116 | — | Availability likely | — |
| Pain Relief Childrens 160 mg 46122-0424-62 | Amerisource | 6 tablets | $0.116 | — | Availability likely | — |
| Chewable Acetaminophen Childrens 160 mgthis 70000-0309-01 | Cardinal | 24 tablets | $0.116 | — | Availability likely | — |
| Chewable Acetaminophen Childrens 160 mg 70000-0310-01 | Cardinal | 24 tablets | $0.116 | — | Availability likely | — |
| Childrens Chewables 160 mg 70677-1127-01 | Strategic | 6 tablets | $0.116 | — | Availability likely | — |
| Childrens Pain and Fever Relief 160 mg 83324-0071-24 | Chain | 24 tablets | $0.116 | — | Availability likely | — |
| Pain and Fever Childrens 160 mg 00363-9440-08 | Walgreen | 6 tablets | — | — | FDA listed | — |
| Acetaminophen 160 mg 00363-9605-07 | WALGREEN | 24 tablets | — | — | FDA listed | — |
| Children Pain and Fever Reliver 160 mg 11673-0240-24 | Target | 6 tablets | — | — | FDA listed | — |
| Children Pain and Fever Reliever 160 mg 11673-0241-24 | Target | 6 tablets | — | — | FDA listed | — |
| pain relief childrens 160 mg 11822-4450-08 | Rite | 24 tablets | — | — | FDA listed | — |
| pain relief childrens 160 mg 11822-9440-08 | Rite | 24 tablets | — | — | FDA listed | — |
| Childrens Pain Relief 160 mg 21130-0223-76 | Better | 6 tablets | — | — | FDA listed | — |
| childrens Pain and Fever 160 mg 36800-0449-08 | Topco | 24 tablets | — | — | FDA listed | — |
| Childrens Pain and Fever 160 mg 36800-0450-08 | Topco | 24 tablets | — | — | FDA listed | — |
| Childrens Pain Reliever 160 mg 37808-0499-08 | H | 6 tablets | — | — | FDA listed | — |
| Pain Reliever Childrens 160 mg 37808-0945-08 | H | 6 tablets | — | — | FDA listed | — |
| childrens acetaminophen 160 mg 41163-0045-08 | United | 6 tablets | — | — | FDA listed | — |
| childrens acetaminophen 160 mg 41163-0494-08 | United | 6 tablets | — | — | FDA listed | — |
| Kroger Children Pain plus Fever chewables 160 mg 41226-0061-24 | KROGER | 6 tablets | — | — | FDA listed | — |
| Children Pain and Fever Reliever 160 mg 41250-0244-24 | MEIJER | 6 tablets | — | — | FDA listed | — |
| Meijer Childrens Pain and Fever Reducer 160 mg 41250-0246-24 | MEIJER | 6 tablets | — | — | FDA listed | — |
| Pain and Fever Childrens 160 mg 49035-0455-08 | Wal-Mart | 6 tablets | — | — | FDA listed | — |
| Pain and Fever Childrens 160 mg 49035-0777-08 | Wal-Mart | 6 tablets | — | — | FDA listed | — |
| Childrens TYLENOL 160 mg 50580-0517-24 | Kenvue | 24 tablets | — | — | FDA listed | — |
| Childrens TYLENOL 160 mg 50580-0521-24 | Kenvue | 24 tablets | — | — | FDA listed | — |
| Childrens Tylenol 160 mg 50580-0522-24 | Kenvue | 24 tablets | — | — | FDA listed | — |
| Pain and Fever Childrens 160 mg 51316-0449-08 | CVS | 24 tablets | — | — | FDA listed | — |
| Pain and Fever Chewables Childrens 160 mg 51316-0450-08 | CVS | 24 tablets | — | — | FDA listed | — |
| Childrens Chewable Acetaminophen 160 mg 53943-0449-08 | Discount | 24 tablets | — | — | FDA listed | — |
| Childrens Pain Relief 160 mg 53943-0836-76 | DISCOUNT | 6 tablets | — | — | FDA listed | — |
| Childrens Pain Relief 160 mg 53943-0837-76 | DISCOUNT | 6 tablets | — | — | FDA listed | — |
| Childrens Acetaminophen 160 mg 55301-0450-08 | ARMY | 24 tablets | — | — | FDA listed | — |
| Pain and Fever Childrens 160 mg 55910-0948-08 | DOLGENCORP, | 6 tablets | — | — | FDA listed | — |
| Childrens Pain Relief 160 mg 58602-0765-76 | Aurohealth | 6 tablets | — | — | FDA listed | — |
| Childrens Pain Relief 160 mg 58602-0766-76 | Aurohealth | 6 tablets | — | — | FDA listed | — |
| Acetaminophen 160 mg 58602-0774-82 | Aurohealth | 48 tablets | — | — | FDA listed | — |
| Non-Aspirin childrens 160 mg 63868-0186-24 | CHAIN | 24 tablets | — | — | FDA listed | — |
| childrens pain reliever 160 mg 63941-0944-08 | Valu | 6 tablets | — | — | FDA listed | — |
| childrens acetaminophen 160 mg 67091-0311-24 | WinCo | 6 tablets | — | — | FDA listed | — |
| Children Pain Relief 160 mg 69168-0440-60 | Allegiant | 60 tablets | — | — | FDA listed | — |
| Mejoralito Children CHILDREN 160 mg 69729-0160-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| Resfriol-ito Children 160 mg 69729-0161-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| Childrens Pain Relief 160 mg 69842-0160-24 | CVS | 6 tablets | — | — | FDA listed | — |
| Pain Relief childrens 160 mg 69842-0449-95 | CVS | 24 tablets | — | — | FDA listed | — |
| Pain Relief childrens 160 mg 69842-0450-94 | CVS | 24 tablets | — | — | FDA listed | — |
| childrens mapap 160 mg 71205-0322-24 | Proficient | 24 tablets | — | — | FDA listed | — |
| Childrens Pain and Fever 160 mg 81522-0155-24 | FSA | 24 tablets | — | — | FDA listed | — |
| Childrens Acetaminophen 160 mg 57896-0155-24 | Geri-Care | 24 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
🏛️
2005
On the market since
Jan 2005
📍
2026
Currently FDA-listed
21 years 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0309-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
160
Units reimbursed last 4 qtrs
5.5K
Gross reimbursed last 4 qtrs
$1.9K
Avg / prescription
$12.02
Avg / unit
$0.3468
Latest quarter Q1 2026
69Rx
Medicaid pays / ea
$0.3468
gross reimbursed
vs
NADAC / ea
$0.1164
acquisition cost
=
Spread
+$0.2304
+198% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 118 Rx Managed care · 42 Rx
State Medicaid map
Units reimbursed · per 100k residents
2.134.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 Chewable Acetaminophen Childrens (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70000-0309-01 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (70000-0309-1) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2005-01-28 | Active |
📄 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 ▾
Uses temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise, use age. chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (chewable tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets 48-59 6-8 2 tablets 60-71 9-10 2 1/2 tablets 72-95 11 3 tablets *or as directed by a doctor
⚠️ Warnings ▾
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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.
Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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 ▾
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number
🧪 Active Ingredient ▾
Active ingredient (in each chewable tablet) Acetaminophen 160 mg
🧪 Inactive Ingredients ▾
Inactive ingredients citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
🎯 Purpose ▾
Purpose Pain reliever/fever reducer
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.