Over-the-counter drug · OTC MONOGRAPH DRUG
Tylenol Extra Strength (Acetaminophen) NDC 50580-378
Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50580-378Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0378Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-378-01 | 50580037801 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Nov 1, 2014 | |
| 50580-378-02 | 50580037802 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-02) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Nov 1, 2014 | |
| 50580-378-03 | 50580037803 | 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-03)Marketed from Apr 6, 2015 | |
| 50580-378-04 | 50580037804 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-04) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2021 | |
| 50580-378-05 | 50580037805 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-05) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2021 | |
| 50580-378-06 | 50580037806 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-06) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2021 | |
| 50580-378-07 | 50580037807 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-07) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2021 | |
| 50580-378-08 | 50580037808 | 325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-08)Marketed from Mar 1, 2021 | |
| 50580-378-37 | 50580037837 | 320 TABLET, FILM COATED in 1 BOTTLE (50580-378-37)Marketed from Mar 31, 2026 |
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 Extra Strength
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet, Film coated
- 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 50580-378_48dff3c9-329f-1300-e063-6294a90a47efSPL ID 48dff3c9-329f-1300-e063-6294a90a47efSPL set ID 17cfa99d-abb2-4d77-9e0e-e77109fbb61aRxCUI 198440, 209459UNII 362O9ITL9D
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
N450580037801followed by a unit qualifier and the quantityPackage 50580-0378-01. 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 relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 50580-378
- What is NDC 50580-378?
- 50580-378 is the product NDC for Tylenol Extra Strength (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tylenol Extra Strength (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 Extra Strength?
- 24 other product NDCs are listed under this name. See all Tylenol Extra Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tylenol Extra Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 960 mg/30mL | SuspensionOral | Kenvue Brands LLC | 50580-187 | 50580-0187-08 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Kenvue Brands LLC | 50580-469 | 50580-0469-1850580-0469-4050580-0469-75 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-108 | 50580-0108-25 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-491 | 50580-0491-0150580-0491-1050580-0491-70 |
| Tylenol Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-472 | 50580-0472-0150580-0472-0250580-0472-03+1 more |
| Tylenol Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | R J General Corporation | 70264-027 | 70264-0027-01 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Kenvue Brands LLC | 50580-490 | 50580-0490-0250580-0490-1050580-0490-20+4 more |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-457 | 50580-0457-1050580-0457-1150580-0457-70 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/.95g | PowderOral | Kenvue Brands LLC | 50580-209 | 50580-0209-0250580-0209-04 |
| Tylenol Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5469 | 50090-5469-00 |
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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