Over-the-counter drug · OTC MONOGRAPH DRUG
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack NDC 50580-526
Kit · Kenvue Brands LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50580-526Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0526Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-526-01 | 50580052601 | 1 KIT in 1 PACKAGE (50580-526-01) * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08)Marketed from Oct 28, 2019 |
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 Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride
- Dosage form
- Kit
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Identifiers
- Product ID 50580-526_2e7d7624-e599-bae7-e063-6394a90aed94SPL ID 2e7d7624-e599-bae7-e063-6394a90aed94SPL set ID 77a2dc96-73ee-4ca2-b1fe-406995802606RxCUI 1369842, 1431245, 2637731UPC 0300450562081, 0300450525086
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450580052601followed by a unit qualifier and the quantityPackage 50580-0526-01. 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 nasal congestion runny nose and sneezing cough sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 50580-526
- What is NDC 50580-526?
- 50580-526 is the product NDC for Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack kit, 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 Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack (Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride).
- 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 Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack?
- 1 other product NDC are listed under this name. See all Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack 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 Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride | — | Kit | Kenvue Brands LLC | 50580-529 | 50580-0529-01 |
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 |
|---|---|---|---|---|
| Cold and Flu HBPacetaminophen, chlorpheniramine maleate | Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-120 |
| Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | WALMART INC. | 79903-417 |
| Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | P & L Development, LLC | 49580-0343 |
| Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-572 |
| SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-450 |
| Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients | LiquidOral | TARGET CORPORATION | 11673-828 |
| Freegells Cough Drops Menthol Cherry 30ctmenthol | Levomenthol 5.8 mg/1 | LozengeOral | RL Albert & Son Inc. | 83002-040 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-173 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Dextrum Laboratories, Inc | 65852-020 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-878 |
| Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | HARRIS TEETER | 72036-274 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl | Acetaminophen 1000 mg/30mL + 3 more ingredients | SyrupOral | Haleon US Holdings LLC | 0067-0114 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin | — | Kit | WALMART INC. | 79903-414 |
| Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | MEIJER DISTRIBUTION INC | 79481-6308 |
| Menthol Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Target Corporation Inc. | 82442-001 |
| adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Meijer Distribution Inc | 41250-261 |
| Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients | LiquidOral | Advanced Generic Corporation | 45737-250 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | AMERISOURCE BERGEN | 46122-829 |
| Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl | — | Kit | L.N.K. International, Inc. | 50844-529 |
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