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Children Acetaminophen Oral Solution 160 mg/5mL Liquid, 473 mL — NDC 00904-7014-16 package photo

Children Acetaminophen Oral Solution 160 mg/5mL Liquid, 473 mL

by MAJOR PHARMACEUTICALS · 473 mL in 1 BOTTLE (0904-7014-16)
NDC 00904-7014-16
🏷️ FDA NDC (as labeled) 0904-7014-16 billing pads the labeler segment with a zero
This package
Contains473 mL Cost per mL$0.0108 NADAC Per package$5.11 / 473 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0343/unit — full pricing hub ↓
Also comes in: 118 ml 00904-7014-20
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) 0904-7014-16
Product NDC 0904-7014
11-digit billing NDC 00904701416
NCPDP billing unit ML — per mL (volume)
RxCUI 307675
UNII 362O9ITL9D
UPC 0309047014200
Application # M013
SPL Set ID cfca5147-f390-40bd-8f13-c5b3b8d1c5b0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-01
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN
GPI-14 64200010002010
GPI class Acetaminophen Childrens
GCN Seq No 004484
GCN 16932
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 CHLD ACETAMINOPHEN 160 MG/5 ML
FDB brand name Children's Acetaminophen
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0904-7014-16 — 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 → 00904-7014-16. 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

LabelerMAJOR PHARMACEUTICALS
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio629 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 CHLD ACETAMINOPHEN 160 MG/5 ML 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.

🧪 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 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 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.

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

The official label also statesInactive ingredients:  artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

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 $0.011 $5.11 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0343 $16.22 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.014 $0.008
▼ Down 3% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Children Acetaminophen Oral Solution 160 mg/5mLthis 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 +127%
M-Pap 160 mg/5mL 58657-0524-04 Method 120 ml $0.024 — Availability likely +127%
Acetaminophen 160 mg/5mL 69367-0323-04 Westminster 118 ml $0.024 — Availability likely +127%
Children Acetaminophen 160 mg/5mL 82568-0008-04 AARNA 1 bottle $0.024 — Availability likely +127%
M-Pap 160 mg/5mL 58657-0525-04 Method 120 ml $0.040 — FDA listed +272%
Acetaminophen 160 mg/5mL 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

🏛️
2019
On the market since
Oct 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.

🗺️ 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 00904-7014-16, 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
254.7K
Units reimbursed last 4 qtrs
55.5M
Gross reimbursed last 4 qtrs
$1.91M
Avg / prescription
$7.48
Avg / unit
$0.0343
Latest quarter Q4 2025
66.1KRx
Medicaid pays / mL
$0.0343
gross reimbursed
vs
NADAC / mL
$0.0108
acquisition cost
=
Spread
+$0.0235
+218% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
46% FFS 54% MCO
Fee-for-service · 116,143 Rx Managed care · 138,603 Rx
State Medicaid map
Alaska: no data reported AK Maine: 433,533 units · 31,078 per 100k residents ME Washington: 1,379,628 units · 17,660 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 35,593 units · 4,546 per 100k residents ND Minnesota: 1,757,000 units · 30,626 per 100k residents MN Wisconsin: 1,413,687 units · 23,920 per 100k residents WI Michigan: 5,559,260 units · 55,388 per 100k residents MI New York: 16,683,401 units · 85,246 per 100k residents NY Vermont: 42,929 units · 6,635 per 100k residents VT New Hampshire: 46,289 units · 3,302 per 100k residents NH Oregon: 357,286 units · 8,440 per 100k residents OR Nevada: 197,238 units · 6,175 per 100k residents NV Wyoming: 3,939 units · 674 per 100k residents WY South Dakota: no data reported SD Iowa: 218,575 units · 6,816 per 100k residents IA Illinois: 1,367,288 units · 10,896 per 100k residents IL Indiana: 1,744,488 units · 25,422 per 100k residents IN Ohio: 3,449,028 units · 29,266 per 100k residents OH Pennsylvania: 1,570,409 units · 12,116 per 100k residents PA New Jersey: 3,666,692 units · 39,469 per 100k residents NJ Massachusetts: 3,116,320 units · 44,512 per 100k residents MA California: 1,108 units · 2.8 per 100k residents CA Utah: 136,950 units · 4,008 per 100k residents UT Colorado: 122,505 units · 2,084 per 100k residents CO Nebraska: 562,856 units · 28,456 per 100k residents NE Missouri: 1,233,745 units · 19,912 per 100k residents MO Kentucky: 2,934,169 units · 64,829 per 100k residents KY West Virginia: 261,242 units · 14,759 per 100k residents WV Virginia: 607,484 units · 6,970 per 100k residents VA Maryland: 742,751 units · 12,019 per 100k residents MD Connecticut: 618,678 units · 17,105 per 100k residents CT Rhode Island: 1,363,278 units · 124,500 per 100k residents RI Arizona: 588,342 units · 7,917 per 100k residents AZ New Mexico: 202,726 units · 9,590 per 100k residents NM Kansas: 327,289 units · 11,132 per 100k residents KS Arkansas: 341,095 units · 11,121 per 100k residents AR Tennessee: 364,564 units · 5,116 per 100k residents TN North Carolina: 7,805 units · 72.0 per 100k residents NC South Carolina: 340,374 units · 6,335 per 100k residents SC Delaware: 385,231 units · 37,365 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 160,323 units · 5,453 per 100k residents MS Alabama: no data reported AL Georgia: 604,657 units · 5,482 per 100k residents GA D.C.: 326,083 units · 48,024 per 100k residents DC Hawaii: 101,083 units · 7,044 per 100k residents HI Texas: no data reported TX Florida: 98,398 units · 435 per 100k residents FL
Units reimbursed · per 100k residents
2.8124,500
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 Rhode Island 124,500 /100k
2 New York 85,246 /100k
3 Kentucky 64,829 /100k
4 Michigan 55,388 /100k
5 D.C. 48,024 /100k
6 Massachusetts 44,512 /100k
7 New Jersey 39,469 /100k
8 Delaware 37,365 /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.
473 ml this page00904-7014-16 254,746 Rx · $1,905,447
118 ml00904-7014-20 214,375 Rx · $1,266,852
Drug total (last 4 qtrs): 469,121 Rx · 92,510,776 units · $3,172,299 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 (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Children Acetaminophen Oral Solution (this brand).

Top reported reactions

Fatigue20,901
Pain18,469
Nausea18,167
Headache17,127
Toxicity To Various Agents15,843
Dyspnoea15,012
Pyrexia14,579

Age at onset

Neonate562
Infant376
Child2,615
Adolescent2,132
Adult26,646
Elderly17,765

Reporter sex

253,624 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization114,315
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,189 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 Per unit Per pack Marketing startStatus
00904-7014-16 You're viewing this 473 mL in 1 BOTTLE (0904-7014-16) $0.0108 / mL $5.09 2019-10-01 Active
00904-7014-20 118 mL in 1 BOTTLE (0904-7014-20) $0.0244 / mL $2.88 2019-10-01 Active

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

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0108 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 54% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00904-7014-16?
NDC 00904-7014-16 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 00904-7014-16 and NDC 00904-7014-20?
Both are Children Acetaminophen Oral Solution 160 mg/5mL Liquid — the drug itself is identical. NDC 00904-7014-16 is the 473 mL package, while NDC 00904-7014-20 is the 118 ml package. Per-mL NADAC also differs: $0.0108 here vs $0.0244 for the 118 ml pack.
What NDC number is used to bill for this package of Children Acetaminophen Oral Solution 160 mg/5mL Liquid?
Bill NDC 00904-7014-16 — the 11-digit billing format is 00904701416. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

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

⏱️ Dosage and Administration 97 words ▾

Directions do not take more than directed find dose in chart below if possible, use weight to dose, otherwise use age dosage may be repeasted every 4 hours, or as directed by a doctor do not give more than 5 doses in 24 hours Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95 Age (years) under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 Dosage Teaspoonful (tsp) consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL)

⚠️ Warnings 210 words ▾

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 thoat 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.

If your child is allergic to acetaminophe or any of the inactive indreadients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is taking the blood thinning drug warfarin.

When using this product: Do not exceed recommended dose. 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 new symptoms occur redness or swelling is present. These could be signs of a serious condition.

🧪 Active Ingredient 9 words ▾

Active ingredient (per 5 mL teaspoonful) Acetaminophen 160 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

🎯 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 ↗
← 00904-7010-06 · Major 00904-7016-04 · Major →
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.