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TYLENOL Extra Strength ACETAMINOPHEN 960 mg/30mL Suspension — NDC 50580-0187-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TYLENOL Extra Strength ACETAMINOPHEN 960 mg/30mL Suspension — NDC 50580-187-08 (Billing 50580-0187-08) · Product 50580-187

by Kenvue Brands LLC · 1 BOTTLE in 1 CARTON (50580-187-08) / 240 mL in 1 BOTTLE

NDC 50580-187-08 (billing 50580-0187-08) is a package of TYLENOL Extra Strength ACETAMINOPHEN 960 mg/30mL Suspension from Kenvue Brands LLC, marketed since Nov 2025 and currently FDA-listed. It is the main listing for product NDC 50580-187, its only package size.

NDC 50580-0187-08
🏷️ FDA NDC (as labeled) 50580-187-08 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50580-187-08
Product NDC 50580-187
11-digit billing NDC 50580018708
RxCUI 307668, 828555
UNII 362O9ITL9D
UPC 0300450420084
Application # M013
SPL Set ID 42321456-d7dd-3b51-e063-6394a90ac292
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-28
Route ORAL
Dosage form SUSPENSION
Substance ACETAMINOPHEN
Quick answers for NDC 50580-187-08
  • RxCUI (RxNorm): 307668
  • 11-digit billing NDC: 50580018708
Why two NDCs? The FDA registers this code as 50580-187-08 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50580-0187-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer 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.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50580-0187-08 50580-187-08 You're viewing this Main listing 1 BOTTLE in 1 CARTON (50580-187-08) / 240 mL in 1 BOTTLE 2025-11-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pain Reliever Childrens 160 mg/5mL 62011-0460-01 Strategic 1 bottle $0.019 — Discontinued —
Pain and Fever Childrens 160 mg/5mL 62011-0461-01 Strategic 1 bottle $0.019 — Discontinued —
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 — Discontinued —
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 $0.041 — Availability likely —
Good Neighbor Pharmacy Infants Pain and Fever 160 mg/5mL 46122-0765-34 Amerisource 1 bottle $0.041 — Availability likely —
foster and thrive infants pain and fever 160 mg/5mL 70677-1253-01 Strategic 1 bottle $0.041 — 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 — Discontinued —
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/30mLthis 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/5mL 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
Nov 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.

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 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 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 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.

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

The official label also statesanhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, 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 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.

Manufacturer & labeler

LabelerKenvue Brands LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio567 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 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 128 words ▾

Directions ■ do not take more than directed (see overdose warning) ■ shake well before using ■ remove child protective cap ■ squeeze the dose into the dosing cup ■ mL = milliliter​ adults and children 12 years and over ■ take 30 mL (2 x 15 mL) every 6 hours while symptoms last. For dosing, the dosing cup needs to be filled to 15 mL line twice. ■ do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor Attention: use only enclosed dosing cup specifically designed for use with this product.

Do not use any other dosing device.

⚠️ Warnings ~1 min read ▾

Warnings Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are 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 more than 10 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.

If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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 for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 37 words ▾

Other information ■ each 30 mL contains: potassium 30 mg ■ store between 20-25°C (68-77°F) ■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing ​

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 30 mL) Acetaminophen 960 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

📄 Do Not Use 44 words ▾

Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product

📄 Ask a Doctor Before Use If 10 words ▾

Ask a doctor before use if you have liver disease

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 When Using This Product 13 words ▾

When using this product do not exceed recommended dose (see overdose warning )

📄 Stop Use and Ask a Doctor If 45 words ▾

Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 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.

🤰 If Pregnant or Breast-Feeding 14 words ▾

If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 9 words ▾

Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL NDC 50580-187-08 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen (960 mg per 30 mL) Oral Suspension Pain Reliever-Fever Reducer Adult Liquid Pain Reliever Dye-Free Alcohol Free 8 fl oz (240 mL) 960 mg per 30 mL Cherry Flavor tylenol-1

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

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

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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) — 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 50580-187-08, 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: 50580-0187-08, written without dashes as 50580018708. 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 50580-0187-08, the first segment (50580) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0187) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kenvue Brands LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50580-0184-01 · Kenvue 50580-0194-01 · Kenvue →
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.