Over-the-counter drug · OTC MONOGRAPH DRUG
Infants TYLENOL (Acetaminophen) NDC 50580-325
Acetaminophen 160 mg/5mL · Suspension · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-325-01 | 5058003250150580032501 | 1 BOTTLE in 1 CARTON (50580-325-01) / 60 mL in 1 BOTTLEMarketed from Sep 25, 2017 |
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)
- Infants TYLENOL
- 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 50580-325_5849b0a1-4892-7e13-e063-6394a90afea9SPL ID 5849b0a1-4892-7e13-e063-6394a90afea9SPL set ID 997b9551-c222-4a9c-8ba1-09a5f97495faRxCUI 307668, 828555UNII 362O9ITL9DUPC 0300450186607
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
N450580032501followed by a unit qualifier and the quantityPackage 50580-0325-01. 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
Excerpt only. Read the full label for complete information.
About NDC 50580-325
- What is NDC 50580-325?
- 50580-325 is the product NDC for Infants TYLENOL (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?
- Infants TYLENOL (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 Infants TYLENOL?
- 3 other product NDCs are listed under this name. See all Infants TYLENOL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Infants TYLENOL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Infants TYLENOLacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-154 | 50580-0154-02 |
| Infants TYLENOLacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-433 | 50580-0433-0150580-0433-02 |
| Infants TYLENOLacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-599 | 50580-0599-0150580-0599-0250580-0599-03 |
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 |
|---|---|---|---|---|
| Headache Relief Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | TARGET Corporation | 11673-686 |
| Aspirin Low Dose Chewableaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Better Living Brands, LLC | 21130-397 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Kenvue Brands LLC | 50580-490 |
| Medlineacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Medline Industries, LP | 53329-194 |
| Acetaminophen Regular Strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Aurohealth LLC | 58602-748 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-018 |
| Mejoralitoacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | OPMX Chula Vista | 69729-068 |
| Ed Apapacetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | EDWARDS PHARMACEUTICALS, INC. | 0485-0057 |
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Advagen Pharma Limited | 72888-459 |
| pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Kroger Company | 30142-590 |
| equate pain relieveracetaminophen | Acetaminophen 500 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-308 |
| Tylenol Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-472 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-092 |
| aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Publix Super Markets Inc | 56062-274 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Aurohealth LLC | 58602-745 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3959 |
| Acetaminophen, Aspirin, Caffeine | Caffeine 65 mg/1 + 2 more ingredients | Tablet, Film coatedOral | CVS Pharmacy, Inc. | 69842-541 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | FSA Store Inc. | 81522-018 |
| Aspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-167 |
| Extra Strenght Headache Reliefacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | Lil' Drug Store Products, Inc. | 29485-6538 |
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