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Acetaminophen 160 mg/5mL Solution — NDC 00121-0657-00 package photo

Acetaminophen 160 mg/5mL Solution

by PAI Holdings, LLC dba PAI Pharma · 10 TRAY in 1 CASE (0121-0657-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0657-05)
NDC 00121-0657-00
🏷️ FDA NDC (as labeled) 0121-0657-00 billing pads the labeler segment with a zero
This package
Contains5 mL in 1 cup, unit-dose Medicaid pays$0.6584 / unit · 12 mo Per package$329.20 / 500 ml · Medicaid Pack sizes3 compare ↓
Also comes in: 10 cups 00121-0657-11 10 cups 00121-0657-21
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 →

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

FDA NDC (as labeled) 0121-0657-00
Product NDC 0121-0657
11-digit billing NDC 00121065700
NCPDP billing unit ML — per mL (volume)
RxCUI 307675
UNII 362O9ITL9D
Application # M013
SPL Set ID 6ec12573-03d6-40c1-9945-d345b401e062
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-08-01
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN
GPI-14 64200010002010
GPI class Acetaminophen
GCN Seq No 065756
GCN 27798
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 ACETAMINOPHEN 160 MG/5 ML CUP
FDB brand name Acetaminophen
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0121-0657-00 — a 4-4-2 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 labeler segment → 00121-0657-00. 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

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedAug 2007
Product typeHuman Otc Drug
Portfolio142 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 ACETAMINOPHEN 160 MG/5 ML CUP 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.
📖 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.

💊 What it looks like

Color red
FlavorCherry
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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 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.

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

The official label also statesCitric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.6584 $329.20 / 500 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
Children Acetaminophen Oral Solution 160 mg/5mL 00904-7014-16 MAJOR 473 ml $0.011 — Availability likely —
Liquid Acetaminophen 160 mg/5mL 54859-0809-16 LLORENS 473 ml $0.011 — Availability likely —
Acetaminophen 160 mg/5mL 57237-0304-12 Rising 118 ml $0.024 — Availability likely —
M-Pap 160 mg/5mL 58657-0524-04 Method 120 ml $0.024 — Availability likely —
Acetaminophen 160 mg/5mL 69367-0323-04 Westminster 118 ml $0.024 — Availability likely —
Children Acetaminophen 160 mg/5mL 82568-0008-04 AARNA 1 bottle $0.024 — Availability likely —
M-Pap 160 mg/5mL 58657-0525-04 Method 120 ml $0.040 — FDA listed —
Acetaminophen 160 mg/5mLthis 00121-0657-00 PAI 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 00121-1047-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-1314-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00121-1971-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-2094-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00121-3141-00 PAI 10 cups — — FDA listed —
Ed Apap 160 mg/5mL 00485-0057-08 EDWARDS 236 ml — — FDA listed —
Acetaminophen 160 mg/5mL 00904-7319-70 Major 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00904-7320-71 Major 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00904-7321-76 Major 10 cups — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0025-01 ATLANTIC 50 cups — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0045-01 ATLANTIC 48 syringes — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0046-01 ATLANTIC 120 syringes — — FDA listed —
MAX relief junior Grape 160 mg/5mL 17856-1122-01 ATLANTIC 50 cups — — FDA listed —
Bactimicina Childrens Pain and Fever 160 mg/5mL 24286-1550-04 DLC 1 bottle — — FDA listed —
Acetaminophen Solution 160 mg/5mL 39328-0031-50 Patrin 10 cups — — FDA listed —
Acetaminophen Solution 325 mg/10.15mL 39328-0032-50 Patrin 10 cups — — FDA listed —
Acetaminophen Solution 650 mg/20.3mL 39328-0034-50 Patrin 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 50090-6059-00 A-S 118 ml — — FDA listed —
Acetaminophen 160 mg/5mL 52343-0555-12 Acetris 118 ml — — FDA listed —
DR. SANA PAIN AND FEVER FOR Children 160 mg/5mL 53113-0516-06 GADAL 1 bottle — — FDA listed —
Acetaminophen 650 mg/20.3mL 55154-9449-05 Cardinal 5 cups — — FDA listed —
GeriCare Liquid Pain Relief 160 mg/5mL 57896-0160-16 Geri-Care 473 ml — — FDA listed —
Acetaminophen 650 mg/20.3mL 60687-0740-37 American 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 60687-0751-56 American 10 cups — — FDA listed —
Little Remedies Infant Fever/Pain Reliever 160 mg/5mL 63029-0610-01 Medtech 1 bottle — — FDA listed —
M-Pap 160 mg/5mL 63629-1157-01 Bryant 120 ml — — FDA listed —
M-Pap 160 mg/5mL 63629-1158-01 Bryant 473 ml — — FDA listed —
Acetaminophen 160 mg/5mL 71205-0730-04 Proficient 118 ml — — FDA listed —
M-Pap 160 mg/5mL 71335-2755-01 Bryant 118 ml — — FDA listed —
M-Pap 160 mg/5mL 72162-1673-02 Bryant 120 ml — — FDA listed —
M-Pap 160 mg/5mL 72162-2404-02 Bryant 473 ml — — FDA listed —
Dr Kids Pain and Fever 160 mg/5mL 73282-2522-01 CalmCo 30 vials — — FDA listed —
Acetaminophen Oral Solution 160 mg/5mL 73564-0816-16 Aldama 1 bottle — — Discontinued —
Childrens Acetaminophen Oral Liquid Grape Flavor 160 mg/5mL 82568-0009-04 AARNA 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 83720-0500-04 Oncor 118 ml — — FDA listed —
Children Acetaminophen Oral Solution 160 mg/5mL 83939-0010-01 VERITYRX. 1 ml — — FDA listed —
M-Pap 160 mg/5mL 83939-0011-01 VERITYRX, 5 ml — — FDA listed —
Childrens Tukol Acetaminophen Fever Reducer Pain Reducer 160 mg/5mL 50066-0525-24 Genomma 118 ml — — FDA listed —
Little Remedies Childrens Fever Pain Reliever 160 mg/5mL 63029-0603-02 Medtech 1 bottle — — FDA listed —
Mejoralito Children 160 mg/5mL 69729-0825-04 OPMX 1 bottle — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 68998-0525-24 Marc 118 ml — — FDA listed —
Revasol Acetaminophen Suspension 160 mg/5mL 84379-0311-16 Rnv 474 ml — — FDA listed —
MAX relief junior 160 mg/5mL 71399-0021-04 Akron 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0084-09 Genexa 1 bottle — — FDA listed —
Neo-Lubrina Children 160 mg/5mL 69729-0827-04 OPMX 1 bottle — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0089-09 Genexa 2 bottles — — FDA listed —
Kids Pain and Fever 160 mg/5mL 69676-0041-03 Genexa 5 ml — — FDA listed —
Childrens Pain and Fever 160 mg/5mL 53943-0526-24 Discount 118 ml — — FDA listed —
Dr. Cocoa for Children Pain and Fever 160 mg/5mL 62372-0200-04 Infirst 1 bottle — — FDA listed —
Revasol Acetaminophen Suspension Dye Free 160 mg/5mL 84379-0357-16 Rnv 474 ml — — FDA listed —
Desenfriol-Ito Plus 160 mg/5mL 69729-0815-04 OPMX 1 bottle — — 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

🏛️
2007
On the market since
Aug 2007
📍
2026
Currently FDA-listed
19 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 00121-0657-00, 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 – Q4 2025 · 4 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
3.2K
Units reimbursed last 4 qtrs
200.7K
Gross reimbursed last 4 qtrs
$132.2K
Avg / prescription
$41.56
Avg / unit
$0.6584
Latest quarter Q4 2025
529Rx
Fee-for-service vs managed care ⓘ
16% FFS 84% MCO
Fee-for-service · 494 Rx Managed care · 2,686 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 214 units · 18.9 per 100k residents MT North Dakota: no data reported ND Minnesota: 16,376 units · 285 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,948 units · 49.3 per 100k residents MI New York: 24,465 units · 125 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 2,455 units · 19.6 per 100k residents IL Indiana: no data reported IN Ohio: 15,120 units · 128 per 100k residents OH Pennsylvania: 41,524 units · 320 per 100k residents PA New Jersey: 65,949 units · 710 per 100k residents NJ Massachusetts: 1,503 units · 21.5 per 100k residents MA California: 1,140 units · 2.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,268 units · 28.0 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 15,101 units · 244 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 8,781 units · 118 per 100k residents AZ New Mexico: 1,895 units · 89.6 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.9710
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
🏆 Top states by units · per 100k residents
1 New Jersey 710 /100k
2 Pennsylvania 320 /100k
3 Minnesota 285 /100k
4 Maryland 244 /100k
5 Ohio 128 /100k
6 New York 125 /100k
7 Arizona 118 /100k
8 New Mexico 89.6 /100k
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 cups this page00121-0657-00 3,180 Rx · $132,177
10 cups00121-0657-11 No Medicaid data
10 cups00121-0657-21 No Medicaid data
Drug total (last 4 qtrs): 3,180 Rx · 200,739 units · $132,177 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen — 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 Acetaminophen — the ingredient across all brands.

Top reported reactions

Pain49,512
Fatigue45,791
Nausea41,932
Overdose40,941
Drug Dependence39,209
Headache38,738
Death36,479

Age at onset

Neonate2,511
Infant1,510
Child4,320
Adolescent3,245
Adult56,522
Elderly41,990

Reporter sex

679,604 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization199,486
Death102,045
Life-threatening29,552
Disabling25,685
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 54,527 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
00121-0657-00 You're viewing this 10 TRAY in 1 CASE (0121-0657-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0657-05) 2007-08-01 Active
00121-0657-11 10 TRAY in 1 CASE (0121-0657-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE 2007-08-01 Active
00121-0657-21 10 TRAY in 1 CASE (0121-0657-21) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE 2007-08-01 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00121-0657-00?
NDC 00121-0657-00 is listed by the FDA — 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose.
What NDC number is used to bill for this package of Acetaminophen 160 mg/5mL Solution?
Bill NDC 00121-0657-00 — the 11-digit billing format is 00121065700. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — 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) ✓ Available
“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 0121-0657-00, 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: 00121-0657-00, written without dashes as 00121065700. 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 00121-0657-00, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC dba PAI Pharma; the middle segment (0657) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 PAI Holdings, LLC dba PAI Pharma. 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 2 other package presentations of this same product, including 10 cups (00121-0657-11), 10 cups (00121-0657-21). 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?
PAI Holdings, LLC dba PAI Pharma is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

⏱️ Dosage and Administration 121 words ▾

Directions do not take more than directed (see overdose warning ) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 2 to under 4 years of age 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 2 years of age consult a doctor

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients of this product Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.

Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

📦 Storage and Handling 132 words ▾

Other information ■ Each 5 mL contains: sodium 2 mg ■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] ■ keep tightly closed ■ protect from light ■ a red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0657-05: 5 mL unit dose cup NDC 0121-0657-00: Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1314-11: 10.15 mL unit dose cup NDC 0121-1314-00: Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1971-21: 20.3 mL unit dose cup NDC 0121-1971-00: Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 5 mL teaspoonful) ACETAMINOPHEN 160 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-0654-02 · PAI 00121-0658-16 · PAI →
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.