Over-the-counter drug · OTC MONOGRAPH DRUG
Extra Strength Tylenol Severe Cough Plus Sore Throat Day NDC 50580-446
acetaminophen and dextromethorphan hydrobromide · Dextromethorphan hydrobromide 15 mg/1; Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50580-446Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0446Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-446-01 | 5058004460150580044601 | 2 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 26, 2024 |
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)
- Extra Strength Tylenol Severe Cough Plus Sore Throat Day
- Generic name (nonproprietary)
- acetaminophen and dextromethorphan hydrobromide
- Active ingredients
- Dextromethorphan hydrobromide — 15 mg/1Acetaminophen — 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 012
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-446_3a1abd26-c0a9-8a65-e063-6294a90ab66eSPL ID 3a1abd26-c0a9-8a65-e063-6294a90ab66eSPL set ID 1a17b24a-8022-4e2f-e063-6294a90af276RxCUI 247324UNII 9D2RTI9KYH, 362O9ITL9DUPC 0300450157348
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N450580044601followed by a unit qualifier and the quantityPackage 50580-0446-01. 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 these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 50580-446
- What is NDC 50580-446?
- 50580-446 is the product NDC for Extra Strength Tylenol Severe Cough Plus Sore Throat Day, Dextromethorphan hydrobromide 15 mg/1; Acetaminophen 500 mg/1 tablet, film coated, 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?
- Extra Strength Tylenol Severe Cough Plus Sore Throat Day (Acetaminophen and Dextromethorphan Hydrobromide).
- What is the active ingredient?
- Dextromethorphan hydrobromide, 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 Extra Strength Tylenol Severe Cough Plus Sore Throat Day?
- 1 other product NDC are listed under this name. See all Extra Strength Tylenol Severe Cough Plus Sore Throat Day NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Extra Strength Tylenol Severe Cough Plus Sore Throat Day products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Dayacetaminophen and dextromethorphan hydrobromide | Acetaminophen 1000 mg/30mL; Dextromethorphan hydrobromide 30 mg/30mL | LiquidOral | Kenvue Brands LLC | 50580-140 | 50580-0140-08 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | WALGREENS | 0363-0100 |
| CVS Health No Dripnasal mist | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CVS PHARMACY,INC. | 69842-815 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 69423-986 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Lidl US LLC | 71141-180 |
| basic care tussin dm maxdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Amazon.com Services LLC | 72288-293 |
| Menthol Cough Drops Honey Vanilla Flavormenthol | Menthol 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-013 |
| equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride | — | Kit | Sixarp, LLC | 59368-459 |
| Nasal Decongestant Maximum Strengthpseudoephedrine hcl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Better Living Brands, LLC | 21130-112 |
| Medicated Chest Rubcamphor, menthol, eucalyptus oil | Camphor (Synthetic) 4.8 g/100g + 2 more ingredients | CreamTopical | Jell Pharmaceuticals Pvt Ltd. | 30400-701 |
| equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-459 |
| NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-044 |
| Childrens Dye Free Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | P & L Development, LLC | 49580-0293 |
| Discount Drug Mart Original Nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-715 |
| Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Family Dollar Services Inc | 55319-705 |
| DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Dolgencorp Inc | 55910-928 |
| Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | LiquidOral | Haleon US Holdings LLC | 0031-8751 |
| Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride | — | KitNasal | Bayer HealthCare LLC. | 11523-0147 |
| Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | TabletOral | Selder, S.A. de C.V. | 63654-605 |
| Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05% | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Lil' Drug Store Products, Inc. | 66715-5526 |
| Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-982 |
Showing 20 of 40.