Over-the-counter drug · OTC MONOGRAPH DRUG
Alka-Seltzer Plus Night Severe Cold and Flu NDC 0280-0922
Acetaminophen 650 mg/1 + 3 more ingredients · Powder, For solution · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0280-0922Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00280-0922Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Alka-Seltzer Plus Night Severe Cold and Flu
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 650 mg/1Dextromethorphan hydrobromide — 20 mg/1Doxylamine succinate — 12.5 mg/1Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.NDC labeler code 0280
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0280-0922_47e3298a-8540-598c-e063-6294a90ada28SPL ID 47e3298a-8540-598c-e063-6294a90ada28SPL set ID f4c60ca1-ba59-4a92-84a5-6ba65faa56abRxCUI 1534835UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJUPC 0016500559399
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0280-0922
- What is NDC 0280-0922?
- 0280-0922 is the product NDC for Alka-Seltzer Plus Night Severe Cold and Flu, Acetaminophen 650 mg/1 + 3 more ingredients powder, for solution, listed with the FDA by Bayer HealthCare LLC..
- What drug is associated with this NDC?
- Alka-Seltzer Plus Night Severe Cold and Flu (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.
- Who is the labeler?
- Bayer HealthCare LLC., NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alka-Seltzer Plus Night Severe Cold and Flu?
- 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 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 |
Showing 20 of 40.