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Childrens Pain and Fever Acetaminophen 160 mg Tablet, Chewable, 24-count — NDC 36800-450-08 (Billing 36800-0450-08)

by Topco Associates, LLC · 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

This is a package of 24 tablets of Childrens Pain and Fever Acetaminophen 160 mg Tablet, Chewable from Topco Associates, LLC, marketed since Feb 2019 and currently FDA-listed. It is this product's only package size.

NDC 36800-0450-08
🏷️ FDA NDC (as labeled) 36800-450-08 billing pads the product segment with a zero
OTC 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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-450-08
Product NDC 36800-450
11-digit billing NDC 36800045008
RxCUI 313820
UNII 362O9ITL9D
UPC 0036800456693
Application # M013
SPL Set ID 87af092c-99e6-475d-81af-b9fd8fc337d7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-15
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 313820
Why two NDCs? The FDA registers this code as 36800-450-08 — 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 → 36800-0450-08. 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

📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
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.

🧪 Full 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.

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.
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
36800-0450-08 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2019-02-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mg 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 mgthis 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 — — Discontinued —
childrens pain reliever 160 mg 63941-0944-08 Valu 6 tablets — — Discontinued —
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

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 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.

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

LabelerTopco Associates, LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedFeb 2019
Product typeHuman Otc Drug
Portfolio59 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 📦 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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Uses temporarily relieves minor aches and pains due to: headache sore throat the common cold toothache flu temporarily reduces fever

⏱️ Dosage and Administration 107 words ▾

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 ~1 min read ▾

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 23 words ▾

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 9 words ▾

Active ingredient (in each chewable tablet) Acetaminophen 160 mg

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

📄 Do Not Use 27 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.

📄 Ask a Doctor Before Use If 11 words ▾

Ask a doctor before use if your child has liver disease.

📄 Ask a Doctor or Pharmacist Before Use If 17 words ▾

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

📄 Stop Use and Ask a Doctor If 34 words ▾

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 43 words ▾

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

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 114 words ▾

Principal display panel +TopCare® health NDC 36800-450-08 † COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S TYLENOL® CHEWABLES children's Pain & Fever ACETAMINOPHEN 160 mg, CHEWABLE TABLETS PAIN RELIEVER • FEVER REDUCER • Ibuprofen Free • Aspirin Free Chew or crush tablets completely before swallowing. BUBBLE GUM FLAVOR 24 CHEWABLE TABLETS For Ages 2 to 11 Years actual size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING QUALITY GUARANTEED † This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children’s Tylenol® Chewables.

50844 REV0424C45008 DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO LNKA1024 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com TopCare 44-450 TopCare 44-450

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

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.

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 Topco Associates, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates, 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.
← 36800-0449-08 · Topco 36800-0451-59 · TOPCO →
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.