Over-the-counter drug · OTC MONOGRAPH DRUG
TYLENOL For Children Plus Adults (Acetaminophen) NDC 50580-177
Acetaminophen 160 mg/5mL · Suspension · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-177-08 | 50580017708 | 1 BOTTLE in 1 CARTON (50580-177-08) / 240 mL in 1 BOTTLEMarketed from Jul 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- TYLENOL For Children Plus Adults
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 160 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 50580-177_35a3c165-116d-b171-e063-6394a90a8abdSPL ID 35a3c165-116d-b171-e063-6394a90a8abdSPL set ID 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42RxCUI 307668, 828555UNII 362O9ITL9DUPC 0300450420084
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450580017708followed by a unit qualifier and the quantityPackage 50580-0177-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps
Excerpt only. Read the full label for complete information.
About NDC 50580-177
- What is NDC 50580-177?
- 50580-177 is the product NDC for TYLENOL For Children Plus Adults (acetaminophen), Acetaminophen 160 mg/5mL suspension, listed with the FDA by Kenvue Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TYLENOL For Children Plus Adults (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TYLENOL For Children Plus Adults?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 013
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 365 whole foods market acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Whole Foods Market, INC. | 42681-0025 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0657 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0941 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1047 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1314 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1882 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1971 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2094 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2823 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-3141 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-9538 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9595 |
| Acetaminophen | Acetaminophen 160 mg/1 | TabletOral | WALGREEN CO. | 0363-9605 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9798 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Rugby Laboratories | 0536-1172 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Rugby Laboratories | 0536-1292 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Rugby Laboratories | 0536-1413 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8608 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8609 |
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