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CHILDRENS ACETAMINOPHEN 160 mg/5mL Suspension, 60 mL

by AARNA USA INC. · 60 mL in 1 BOTTLE (82568-0010-2)
NDC 82568-0010-02
🏷️ FDA NDC (as labeled) 82568-0010-2 billing pads the package segment with a zero
This package
Contains60 mL Pack sizes4 compare ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 82568-0010-2
Product NDC 82568-0010
11-digit billing NDC 82568001002
RxCUI 307668
UNII 362O9ITL9D
Application # M013
SPL Set ID 38070d15-2678-4e59-e063-6294a90ab690
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-20
Route ORAL
Dosage form SUSPENSION
Substance ACETAMINOPHEN
GPI-14 64200010001840
Why two NDCs? The FDA registers this code as 82568-0010-2 — 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 → 82568-0010-02. 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

LabelerAARNA USA INC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code82568
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio19 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

📖 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.
📖 Read our full Acetaminophen guide →
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

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAnhydrous Citric Acid, D&C Red #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.

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 DailyMedingredient 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 mLPer 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: 118 ml 236 ml 473 ml
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
Pain Reliever Childrens 160 mg/5mL 62011-0460-01 Strategic 1 bottle $0.019 FDA listed
Pain and Fever Childrens 160 mg/5mL 62011-0461-01 Strategic 1 bottle $0.019 FDA listed
leader childrens pain and fever 160 mg/5mL 70000-0496-01 Cardinal 1 bottle $0.019 FDA listed
Childrens Pain Relief 160 mg/5mL 63868-0174-18 QUALITY 118 ml $0.021 FDA listed
Pain Relief Childrens 160 mg/5mL 63868-0175-26 QUALITY 1 bottle $0.021 FDA listed
good sense childrens pain and fever 160 mg/5mL 00113-0020-26 L. 1 bottle $0.021 Availability likely
Good Sense Childrens Pain and Fever 160 mg/5mL 00113-0212-26 L. 1 bottle $0.021 Availability likely
good sense childrens pain and fever 160 mg/5mL 00113-0608-26 L. 1 bottle $0.021 Availability likely
Good Sense Pain and Fever 160 mg/5mL 00113-8959-26 L. 1 bottle $0.021 Availability likely
Rugby Childrens Acetaminophen 160 mg/5mL 00536-1321-97 Rugby 1 bottle $0.021 Availability likely
childrens acetaminophen 160 mg/5mL 00904-7445-20 Major 1 bottle $0.021 Availability likely
Childrens Acetaminophen 160 mg/5mL 45802-0201-26 Padagis 1 bottle $0.021 Availability likely
Good Neighbor Pharmacy Childrens Pain and Fever 160 mg/5mL 46122-0209-26 Amerisource 1 bottle $0.021 Availability likely
Good Neighbor Pharmacy childrens pain and fever 160 mg/5mL 46122-0211-26 Amerisource 1 bottle $0.021 Availability likely
good neighbor pharmacy pain and fever childrens 160 mg/5mL 46122-0322-26 Amerisource 1 bottle $0.021 Availability likely
leader childrens pain and fever 160 mg/5mL 70000-0028-01 Cardinal 1 bottle $0.021 Availability likely
leader childrens pain and fever 160 mg/5mL 70000-0481-01 Cardinal 1 bottle $0.021 Availability likely
foster and thrive childrens pain and fever 160 mg/5mL 70677-1142-01 Strategic 1 bottle $0.021 Availability likely
foster and thrive childrens pain and fever 160 mg/5mL 70677-1143-01 Strategic 1 bottle $0.021 Availability likely
Childrens Acetaminophen 160 mg/5mL 72888-0459-01 Advagen 1 bottle $0.021 Availability likely
Childrens Acetaminophen 160 mg/5mL 82568-0011-04 AARNA 1 bottle $0.021 Availability likely
Pain Relief 160 mg/5mL 83324-0034-04 QUALITY 1 bottle $0.021 Availability likely
Pain Reliever 160 mg/5mL 83324-0161-04 QUALITY 1 bottle $0.021 Availability likely
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry 160 mg/5mL 83474-0001-04 Puro 1 bottle $0.021 Availability likely
Children Acetaminophen 160 mg/5mL 82568-0008-04 AARNA 1 bottle $0.024 Availability likely
good neighbor pharmacy infants pain and fever 160 mg/5mL 46122-0764-34 Amerisource 1 bottle $0.039 Availability likely
Good Neighbor Pharmacy Infants Pain and Fever 160 mg/5mL 46122-0765-34 Amerisource 1 bottle $0.039 Availability likely
foster and thrive infants pain and fever 160 mg/5mL 70677-1253-01 Strategic 1 bottle $0.039 Availability likely
rugby infants acetaminophen 160 mg/5mL 00536-1426-77 Rugby 1 bottle $0.058 Availability likely
leader infants pain and fever 160 mg/5mL 70000-0674-01 Cardinal 1 bottle $0.058 Availability likely
Infants Pain Reliever 160 mg/5mL 70677-0117-01 Strategic 1 bottle $0.062 FDA listed
Good Sense pain and fever 160 mg/5mL 00113-0161-10 L. 1 bottle $0.084 Availability likely
good sense pain and fever infants 160 mg/5mL 00113-0946-10 L. 1 bottle $0.084 Availability likely
Acetaminophen 160 mg/5mL 00121-0941-00 PAI 10 cups FDA listed
Dye Free Childrens Acetaminophen 160 mg/5mL 00121-0966-00 PAI 10 cups FDA listed
Childrens Acetaminophen 160 mg/5mL 00121-1781-00 PAI 10 cups FDA listed
Acetaminophen 325 mg/10.15mL 00121-1882-00 PAI 10 cups FDA listed
Acetaminophen 650 mg/20.3mL 00121-2823-94 PAI 10 cups FDA listed
childrens pain and fever 160 mg/5mL 00363-0212-26 Walgreen 1 bottle FDA listed
Dye Free Pain and Fever Childrens 160 mg/5mL 00363-0283-04 Walgreens 1 bottle FDA listed
Dye Free Pain and Fever Childrens 160 mg/5mL 00363-0285-04 Walgreens 1 bottle FDA listed
Childrens Pain and Fever Cherry flavor 160 mg/5mL 00363-0322-24 Walgreen 1 bottle FDA listed
Childrens Pain and Fever, Grape flavor 160 mg/5mL 00363-0323-24 Walgreen 1 bottle FDA listed
childrens pain and fever 160 mg/5mL 00363-1239-26 Walgreen 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 00363-1630-94 Walgreen 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 00363-6002-02 WALGREEN 1 bottle FDA listed
Dye FreeInfants Pain and Fever 160 mg/5mL 00363-6020-02 WALGREEN 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 00363-6555-04 WALGREENS 1 bottle FDA listed
WalgreenChildrens Pain Fever 160 mg/5mL 00363-6950-04 WALGREENS 1 bottle FDA listed
Walgreen Childrens Pain plus Fever 160 mg/5mL 00363-6958-08 WALGREENS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 00363-7014-05 WALGREENS 1 bottle FDA listed
Dye Free Infants Pain and Fever 160 mg/5mL 00363-7015-04 WALGREENS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 00363-8079-36 Walgreen 1 bottle FDA listed
Childrens Acetaminophen 160 mg/5mL 00904-7278-70 Major 10 cups FDA listed
Up and Up childrens acetaminophen 160 mg/5mL 11673-0105-26 Target 1 bottle FDA listed
Up and Up Childrens acetaminophen 160 mg/5mL 11673-0130-26 Target 1 bottle FDA listed
up and up acetaminophen infants 160 mg/5mL 11673-0133-16 Target 1 bottle FDA listed
up and up infants acetaminophen 160 mg/5mL 11673-0266-16 Target 1 bottle FDA listed
childrens fever reducer and pain reliever 160 mg/5mL 11822-0107-01 Rite 1 bottle FDA listed
infants fever reducer and pain reliever 160 mg/5mL 11822-0590-01 Rite 1 bottle FDA listed
childrens fever reducer and pain reliever 160 mg/5mL 11822-0595-04 Rite 1 bottle FDA listed
infants fever reducer and pain reliever 160 mg/5mL 11822-0766-01 Rite 1 bottle FDA listed
childrens fever reducer and pain reliever 160 mg/5mL 11822-0959-01 Rite 1 bottle FDA listed
MAX relief junior Grape 160 mg/5mL 17856-1123-01 ATLANTIC 72 cups FDA listed
signature care infants pain relief 160 mg/5mL 21130-0178-16 Safeway 1 bottle FDA listed
signature care childrens pain relief 160 mg/5mL 21130-0243-26 Safeway 1 bottle FDA listed
Dye Free Pain Reliever Childrens 160 mg/5mL 21130-0285-04 Safeway, 1 bottle FDA listed
better living brands childrens fever and pain reliver 160 mg/5mL 21130-0746-04 BETTER 1 bottle FDA listed
Childrens Pain Relief Dye free 160 mg/5mL 21130-0910-05 BETTER 1 bottle FDA listed
pain and fever 160 mg/5mL 30142-0590-16 Kroger 1 bottle FDA listed
infants pain and fever 160 mg/5mL 30142-0766-16 Kroger 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 30142-0818-26 Kroger 1 bottle FDA listed
Topcare pain and fever 160 mg/5mL 36800-0161-10 Topco 1 bottle FDA listed
topcare childrens pain and fever 160 mg/5mL 36800-0202-26 Topco 1 bottle FDA listed
topcare infants pain and fever 160 mg/5mL 36800-0590-16 Topco 1 bottle FDA listed
topcare infants pain and fever 160 mg/5mL 36800-0766-16 Topco 1 bottle FDA listed
topcare infants pain and fever 160 mg/5mL 36800-0946-10 Topco 1 bottle FDA listed
pain relief 160 mg/5mL 37808-0130-26 H 1 bottle FDA listed
Pain and Fever 160 mg/5mL 37808-0161-16 H 1 bottle FDA listed
Pain Relief Childrens Dye Free 160 mg/5mL 37808-0285-04 H 1 bottle FDA listed
Childrens Pain Relief 160 mg/5mL 37808-0482-04 H 1 bottle FDA listed
equaline childrens acetaminophen 160 mg/5mL 41163-0473-26 United 1 bottle FDA listed
Childrens Pain and Fever Dye Free 160 mg/5mL 41226-0779-05 KROGER 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 41226-0910-04 Kroger 1 bottle FDA listed
Pain and Fever 160 mg/5mL 41250-0161-16 Meijer 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 41250-0554-26 Meijer 1 bottle FDA listed
pain and fever 160 mg/5mL 41250-0590-16 Meijer 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 41250-0631-26 Meijer 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 41250-0650-26 Meijer 1 bottle FDA listed
pain and fever 160 mg/5mL 41250-0766-16 Meijer 1 bottle FDA listed
pain and fever 160 mg/5mL 41250-0946-10 Meijer 1 bottle Discontinued
childrens pain and fever 160 mg/5mL 41250-0959-26 Meijer 1 bottle FDA listed
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0023-26 American 1 bottle FDA listed
CareOne Infants Acetaminophen 160 mg/5mL 41520-0363-10 American 1 bottle Discontinued
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0615-26 American 1 bottle FDA listed
careone childrens acetaminophen 160 mg/5mL 41520-0624-26 American 1 bottle FDA listed
CareOne Infants Acetaminophen 160 mg/5mL 41520-0709-10 American 1 bottle FDA listed
CareOne Childrens Acetaminophen 160 mg/5mL 41520-0800-26 American 1 bottle FDA listed
Childrens Pain And Fever 160 mg/5mL 42507-0148-26 HyVee 1 bottle FDA listed
childrens pain and fever 160 mg/5mL 42507-0804-26 HyVee 1 bottle FDA listed
good neighbor pharmacy childrens pain and fever 160 mg/5mL 46122-0210-25 Amerisource 1 bottle Discontinued
equate pain and fever childrens 160 mg/5mL 49035-0042-26 Wal-Mart 1 bottle FDA listed
Equate Childrens Pain and Fever 160 mg/5mL 49035-0313-26 Wal-Mart 1 bottle FDA listed
Parents Choice Infants Pain and Fever 160 mg/5mL 49035-0766-16 Wal-Mart 1 bottle FDA listed
equate pain and fever infants 160 mg/5mL 49035-0946-10 Wal-Mart 1 bottle Discontinued
equate childrens pain and fever 160 mg/5mL 49035-0959-26 Wal-Mart 1 bottle Discontinued
Pain and Fever Childrens 160 mg/5mL 49580-0282-02 P 118 ml FDA listed
Dye Free Pain Reliever Childrens 160 mg/5mL 49580-0685-04 P 1 bottle FDA listed
Pain Relief 160 mg/5mL 49580-0821-04 P 1 bottle FDA listed
Pain Reliever 160 mg/5mL 49580-2880-04 P 1 bottle FDA listed
Childrens Tukol Acetaminophen Fever Reducer Pain Reducer 160 mg/5mL 50066-0525-24 Genomma 118 ml FDA listed
good sense childrens pain and fever 160 mg/5mL 50090-7254-00 A-S 1 bottle FDA listed
Childrens Tylenol 160 mg/5mL 50580-0139-04 Kenvue 1 bottle FDA listed
Infants TYLENOL 160 mg/5mL 50580-0154-02 Kenvue 1 bottle FDA listed
Childrens TYLENOL 160 mg/5mL 50580-0170-01 Kenvue 1 bottle FDA listed
TYLENOL For Children Plus Adults 160 mg/5mL 50580-0177-08 Kenvue 1 bottle FDA listed
TYLENOL Extra Strength 960 mg/30mL 50580-0187-08 Kenvue 1 bottle FDA listed
Infants TYLENOL 160 mg/5mL 50580-0325-01 Kenvue 1 bottle FDA listed
Childrens TYLENOL 160 mg/5mL 50580-0424-01 Kenvue 1 bottle FDA listed
Infants TYLENOL 160 mg/5mL 50580-0433-01 Kenvue 1 bottle FDA listed
Childrens TYLENOL 160 mg/5mL 50580-0509-01 Kenvue 1 bottle FDA listed
Childrens TYLENOL 160 mg/5mL 50580-0579-02 Kenvue 1 bottle FDA listed
Infants TYLENOL 160 mg/5mL 50580-0599-01 Kenvue 1 bottle FDA listed
Childrens TYLENOL 160 mg/5mL 50580-0612-01 Kenvue 1 bottle FDA listed
Childrens TYLENOL 160 mg/5mL 50580-0614-01 Kenvue 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 51316-0097-19 CVS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 51316-0098-19 CVS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 51316-0099-19 CVS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 51316-0282-04 CVS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 51316-0324-04 CVS 1 bottle FDA listed
Childrens Pain plus Fever Relief 160 mg/5mL 51316-0569-04 CVS 1 bottle FDA listed
infants pain and fever 160 mg/5mL 51316-0606-16 CVS 1 bottle FDA listed
Dye Free Infants Pain and Fever 160 mg/5mL 51316-0643-04 CVS 1 bottle FDA listed
CVS Childrens Pain plus Fever Relief 160 mg/5mL 51316-0695-04 CVS 1 bottle FDA listed
FeverAll 160 mg/5mL 51672-5319-08 Sun 1 bottle FDA listed
Pediacare Childrens Grape 160 mg/5mL 52412-0901-04 RANDOB 1 bottle FDA listed
Pediacare Childrens Acetaminophen Grape 160 mg/5mL 52412-0906-01 RANDOB 1 bottle FDA listed
Fast Acting Pedia Crae 160 mg/5mL 52412-0912-01 Randob 1 bottle FDA listed
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRY 160 mg/5mL 53942-0525-24 DeMoulas 1 bottle FDA listed
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPE 160 mg/5mL 53942-0526-24 DeMoulas 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 53943-0526-24 Discount 118 ml FDA listed
Llorens Care Children Acetaminophen 160 mg/5mL 54859-0850-04 Llorens 118 ml FDA listed
Childrens Acetaminophen 160 mg/5mL 55154-5787-05 Cardinal 5 cups FDA listed
Childrens Pain Relief 160 mg/5mL 55319-0060-36 Family 1 bottle FDA listed
Dye Free Infants Pain and Fever 160 mg/5mL 55319-0206-02 FAMILY 1 bottle FDA listed
Pain Reliever 160 mg/5mL 55319-0558-08 Family 1 bottle FDA listed
Pain Reliever 160 mg/5mL 55319-0559-04 Family 1 bottle FDA listed
Family Wellness Childrens Pain Reliever 574 160 mg/5mL 55319-0930-03 Family 1 bottle FDA listed
Dolex Children Pain and Fever 160 mg/5mL 55758-0026-04 Pharmadel 1 bottle FDA listed
dg health childrens pain and fever 160 mg/5mL 55910-0010-26 Dolgencorp 1 bottle FDA listed
DG Health Childrens Pain and Fever 160 mg/5mL 55910-0251-26 Dolgencorp, 1 bottle FDA listed
Pain Relief Childrens 160 mg/5mL 55910-0282-08 Dolgencorp, 1 bottle FDA listed
dg health childrens pain and fever 160 mg/5mL 55910-0738-26 Dolgencorp 1 bottle FDA listed
childrens pain relief 160 mg/5mL 56062-0130-26 Publix 1 bottle FDA listed
pain relief 160 mg/5mL 56062-0590-16 Publix 1 bottle FDA listed
Infants Pain Relief 160 mg/5mL 56062-0766-16 Publix 1 bottle FDA listed
infants pain relief 160 mg/5mL 56062-0946-10 Publix 1 bottle FDA listed
INFANTS Pain and Fever 160 mg/5mL 58602-0168-11 Aurohealth 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 58602-0169-11 Aurohealth 1 bottle FDA listed
INFANTS Pain and Fever 160 mg/5mL 58602-0172-11 Aurohealth 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 58602-0173-11 Aurohealth 1 bottle FDA listed
infants pain fever 160 mg/5mL 59640-0590-16 H 1 bottle FDA listed
infants pain fever 160 mg/5mL 59640-0766-16 H 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 59779-0126-26 CVS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 59779-0308-26 CVS 1 bottle FDA listed
infants pain and fever 160 mg/5mL 59779-0590-16 CVS 1 bottle FDA listed
Pain and Fever Childrens 160 mg/5mL 59779-0785-08 CVS 1 bottle FDA listed
Childrens Acetaminophen Oral Suspension 160 mg/5mL 60687-0762-17 American 10 cups FDA listed
Dr. Cocoa for Children Pain and Fever 160 mg/5mL 62372-0200-04 Infirst 1 bottle FDA listed
Little Remedies Childrens Fever Pain Reliever 160 mg/5mL 63029-0603-02 Medtech 1 bottle FDA listed
Acetaminophen 160 mg/5mL 63868-0677-60 CHAIN 60 ml FDA listed
Acetaminophen 160 mg/5mL 63868-0678-60 CHAIN 60 ml FDA listed
Childrens Pain and Fever 160 mg/5mL 63941-0282-04 Best 1 bottle FDA listed
Lil Drug Store Childrens Pain and Fever 160 mg/5mL 66715-6956-04 Lil' 1 bottle FDA listed
Childrens Pain Relief Dye-Free 160 mg/5mL 67091-0119-18 WinCo 1 bottle FDA listed
good sense childrens pain and fever 160 mg/5mL 68071-3869-04 NuCare 1 bottle FDA listed
Acetaminophen 160 mg/5mL 68071-4860-04 NuCare 118 ml FDA listed
Acetaminophen 160 mg/5mL 68094-0030-62 Precision 10 cups FDA listed
Acetaminophen 160 mg/5mL 68094-0038-58 Precision 10 syringes FDA listed
Acetaminophen 160 mg/5mL 68094-0042-58 Precision 10 syringes FDA listed
Dye Free Childrens Acetaminophen 160 mg/5mL 68094-0061-61 Precision 10 cups FDA listed
Acetaminophen 160 mg/5mL 68094-0130-58 Precision 10 syringes FDA listed
Acetaminophen 160 mg/5mL 68094-0231-61 Precision 10 cups FDA listed
Acetaminophen 160 mg/5mL 68094-0330-61 Precision 10 cups FDA listed
ADWE Childrens Pain Fever 160 mg/5mL 68163-0695-04 RARITAN 1 bottle FDA listed
Childrens Pain Reliever 160 mg/5mL 68391-0288-12 BJWC 3 bottles FDA listed
Childrens Acetaminophen 160 mg/5mL 68788-8397-01 Preferred 1 bottle FDA listed
Good Sense Childrens Pain and Fever 160 mg/5mL 68788-8407-01 Preferred 1 bottle FDA listed
good sense childrens pain and fever 160 mg/5mL 68788-8477-01 Preferred 1 bottle FDA listed
Good Sense Pain and Fever 160 mg/5mL 68788-8646-01 Preferred 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 68998-0525-24 Marc 118 ml FDA listed
Childrens Pain Relief 160 mg/5mL 69168-0455-53 Allegiant 1 bottle FDA listed
Kids Pain and Fever 160 mg/5mL 69676-0041-03 Genexa 5 ml FDA listed
Genexa Infants Pain and Fever 160 mg/5mL 69676-0042-09 Genexa 1 bottle FDA listed
Kids Pain and Fever 160 mg/5mL 69676-0084-09 Genexa 1 bottle FDA listed
Kids Pain and Fever 160 mg/5mL 69676-0089-09 Genexa 2 bottles FDA listed
Infants Pain and Fever Cherry Flavor 160 mg/5mL 69676-0097-09 Genexa 1 bottle FDA listed
Genexa Kids Pain and Fever 160 mg/5mL 69676-0099-09 Genexa 1 bottle FDA listed
Genexa Infants Pain and Fever 160 mg/5mL 69676-0100-09 Genexa 1 bottle FDA listed
Genexa Infants Pain and Fever 160 mg/5mL 69676-0121-09 Genexa 1 bottle FDA listed
Temperal-ito 160 mg/5mL 69729-0006-02 OPMX 1 bottle FDA listed
Acetaminophen 160 mg/5mL 69729-0028-02 OPMX 60 ml FDA listed
Temp X 160 mg/5mL 69729-0047-02 OPMX 60 ml FDA listed
Mejoralito 160 mg/5mL 69729-0068-02 OPMX 60 ml FDA listed
Neo-Lubrina 160 mg/5mL 69729-0118-04 OPMX 1 bottle FDA listed
Desenfriol-Ito Plus 160 mg/5mL 69729-0815-04 OPMX 1 bottle FDA listed
Mejoralito Children 160 mg/5mL 69729-0825-04 OPMX 1 bottle FDA listed
Neo-Lubrina Children 160 mg/5mL 69729-0827-04 OPMX 1 bottle FDA listed
childrens pain and fever 160 mg/5mL 69842-0959-26 CVS 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 70677-1286-01 Strategic 473 ml FDA listed
Childrens Acetaminophen 160 mg/5mL 71205-0263-04 Proficient 1 bottle FDA listed
Good Sense Childrens Pain and Fever 160 mg/5mL 71205-0601-04 Proficient 1 bottle FDA listed
Childrens Acetaminophen 160 mg/5mL 71335-2722-01 Bryant 1 bottle FDA listed
MAX relief junior 160 mg/5mL 71399-0020-04 Akron 1 bottle FDA listed
MAX relief junior 160 mg/5mL 71399-0021-04 Akron 1 bottle FDA listed
MAX relief junior Grape 160 mg/5mL 71399-0022-04 Akron 1 bottle FDA listed
MAX relief junior 160 mg/5mL 71399-0038-04 Akron 1 bottle FDA listed
MAX relief junior Grape 160 mg/5mL 71399-0048-02 Akron 1 bottle FDA listed
Mommys Bliss Childrens Pain and Fever 160 mg/5mL 71444-0793-01 Mom 118 ml FDA listed
Mommys Bliss Infants Pain and Fever 160 mg/5mL 71444-0893-01 Mom 59 ml FDA listed
Childrens Acetaminophen 160 mg/5mL 72162-2279-02 Bryant 1 bottle FDA listed
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0105-26 Amazon.com 1 bottle FDA listed
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0130-26 Amazon.com 1 bottle FDA listed
basic care childrens pain and fever 160 mg/5mL 72288-0175-26 Amazon.com 1 bottle FDA listed
basic care infants pain and fever 160 mg/5mL 72288-0590-16 Amazon.com 1 bottle FDA listed
basic care infants pain and fever 160 mg/5mL 72288-0766-16 Amazon.com 1 bottle FDA listed
basic care infants pain and fever 160 mg/5mL 72288-0946-16 Amazon.com 1 bottle FDA listed
Basic Care Childrens Pain and Fever 160 mg/5mL 72288-0959-26 Amazon.com 1 bottle FDA listed
Careone Infants Acetaminophen 160 mg/5mL 72476-0766-16 Retail 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 76162-0079-36 TOPCO 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 76281-0525-24 AptaPharma 1 bottle FDA listed
Childrens Pain and Fever 160 mg/5mL 76281-0526-24 AptaPharma 1 bottle FDA listed
Pain Reliever 160 mg/5mL 79903-0172-04 WALMART 1 bottle FDA listed
equate infants pain and fever 160 mg/5mL 79903-0225-02 WALMART 1 bottle FDA listed
Pain Relief Fever Reducer children 160 mg/5mL 80272-0002-04 Ellywell, 1 bottle FDA listed
CHILDRENS Acetaminophen 160 mg/5mL 81033-0026-01 Kesin 100 cups FDA listed
Childrens Acetaminophen Dye Free Grape 160 mg/5mL 81522-0285-04 FSA 1 bottle FDA listed
KOSHER MEDS Childrens Pain and Fever 160 mg/5mL 82179-0002-04 Mollec 1 bottle FDA listed
Childrens Acetaminophen 160 mg/5mLthis 82568-0010-02 AARNA 60 ml FDA listed
Infants Pain and Fever 160 mg/5mL 82673-0096-02 KinderFarms, 1 bottle FDA listed
Pain and Fever Childrens 160 mg/5mL 82673-0097-04 KinderFarms, 1 bottle FDA listed
Infants Pain and Fever 160 mg/5mL 82673-0098-02 KinderFarms, 1 bottle FDA listed
Kids Pain and Fever 160 mg/5mL 82673-0104-04 KinderFarms, 1 bottle FDA listed
Revasol Acetaminophen Suspension 160 mg/5mL 84379-0311-16 Rnv 474 ml FDA listed
Revasol Acetaminophen Suspension Dye Free 160 mg/5mL 84379-0357-16 Rnv 474 ml FDA listed
Childrens Acetaminophen 160 mg/5mL 85828-0922-05 Grocery 1 bottle FDA listed
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL 160 mg/5mL 87078-0121-52 MEDWISE 12 pouches FDA listed
OneSsip Acetaminophen 160 mg/5mL 87078-0131-52 MEDWISE 12 pouches FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

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

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 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 Childrens Acetaminophen (this brand).

Top reported reactions

Fatigue20,901
Pain18,470
Nausea18,168
Headache17,128
Toxicity To Various Agents15,843
Dyspnoea15,012
Pyrexia14,580

Reporter sex

0 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization114,318
Death49,979
Life-threatening21,902
Disabling12,025
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,614 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
82568-0010-02 You're viewing this 60 mL in 1 BOTTLE (82568-0010-2) 2025-06-20 Active
82568-0010-04 118 mL in 1 BOTTLE (82568-0010-4) 2025-06-20 Active
82568-0010-06 473 mL in 1 BOTTLE (82568-0010-6) 2025-06-20 Active
82568-0010-08 236 mL in 1 BOTTLE (82568-0010-8) 2025-06-20 Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 82568-0010-02?
NDC 82568-0010-02 contains 60 mL — 60 ml in 1 bottle.
What is the difference between NDC 82568-0010-02 and NDC 82568-0010-04?
Both are CHILDRENS ACETAMINOPHEN 160 mg/5mL Suspension — the drug itself is identical. NDC 82568-0010-02 is the 60 mL package, while NDC 82568-0010-04 is the 118 ml package.
What NDC number is used to bill for this package of CHILDRENS ACETAMINOPHEN 160 mg/5mL Suspension?
Bill NDC 82568-0010-02 — the 11-digit billing format is 82568001002. 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 — Not published for this NDC No photo available yet for this listing.
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 — 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 FDA registers it as 82568-0010-2, 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: 82568-0010-02, written without dashes as 82568001002. 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 82568-0010-02, the first segment (82568) is the labeler code FDA assigned to AARNA USA INC.; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 AARNA USA 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 3 other package presentations of this same product, including 118 ml (82568-0010-04), 236 ml (82568-0010-08), 473 ml (82568-0010-06). 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?
AARNA USA 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 28 words

Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)

⏱️ Dosage and Administration 156 words

Directions This product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL=milliliter find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lbs.) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 24 to 35 2 to 3 1 tsp or 5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 48 to 59 6 to 8 2 tsp or 10 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 72 to 95 11 3 tsp or 15 mL *or as directed by a doctor Attention: use only enclosed dosing cup designed for use with this product.

Do not use any other dosing device.

⚠️ Warnings ~1 min read

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more then 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: A cetaminophen 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, persist or 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. if your child is allergic to acetaminophen or anyof the inactive ingredients in this product.

Ask a doctor or pharmacist before use if the child has liver disease. Ask doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if pain gets worse or lasts for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present.

These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Keep out of Reach of children

📦 Storage and Handling 14 words

Other Information Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.

🧪 Active Ingredient 14 words

Active Ingredient Active ingredient (in each 5mL) Purpose Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

🧪 Inactive Ingredients 29 words

Inactive Ingredients Anhydrous Citric Acid, D&C Red #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.

🎯 Purpose 19 words

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

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.