Over-the-counter drug · OTC MONOGRAPH DRUG
Alka-Seltzer Plus Day Severe Cold Plus Flu NDC 0280-0921
Acetaminophen 500 mg/1 + 3 more ingredients · Powder, For solution · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0280-0921Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00280-0921Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Alka-Seltzer Plus Day Severe Cold Plus Flu
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 500 mg/1Dextromethorphan hydrobromide — 20 mg/1Guaifenesin — 400 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)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0280-0921_47e32f69-3232-a960-e063-6394a90a8590SPL ID 47e32f69-3232-a960-e063-6394a90a8590SPL set ID cec51eab-cce3-4965-a14e-a46d953050c4RxCUI 1550968UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJUPC 0016500559429
- Pharmacologic class
- Expectorant; 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: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0280-0921
- What is NDC 0280-0921?
- 0280-0921 is the product NDC for Alka-Seltzer Plus Day Severe Cold Plus Flu, Acetaminophen 500 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 Day Severe Cold Plus Flu (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, 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 Day Severe Cold Plus 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 |
|---|---|---|---|---|
| Multi-Symptom Nighttime Cold and Flu Reliefacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-316 |
| MGC Healthcough drops honey | Menthol 7.5 mg/1 | LozengeOral | Medical Group Care LLC | 83173-114 |
| Nuvicare DayTime and NightTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate | — | Kit | NUVICARE LLC | 84324-025 |
| VICKS DayQuil NyQuil SEVERE HONEY COLD and FLUacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl and doxylamine succinate | — | KitOral | The Procter & Gamble Manufacturing Company | 84126-326 |
| Good Sense Nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | Sportpharm LLC | 85766-164 |
| Major Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | Major Pharmaceuticals | 0904-7435 |
| equaline nasalphenylephrine hydrochloride | Phenylephrine hydrochloride 1 g/100mL | SprayNasal | United Natural Foods, Inc. dba UNFI | 41163-648 |
| Otis Clapp Valihistacetaminophen,chlorpheniramine maleate, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-543 |
| Daytime Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl | — | KitOral | CVS HEALTH CORP | 51316-527 |
| Sorbugendextromethorphan hydrobromide, glycerol guaiacolate | Dextromethorphan hydrobromide 15 mg/7.5mL; Guaifenesin 150 mg/7.5mL | SyrupOral | Kramer Novis | 52083-660 |
| allergy relief childrensdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-874 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gelsacetaminophen, chlorpheniramine malaeate, dextromethorphan hydrobromide, phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Bayer HealthCare LLC. | 0280-0092 |
| Tylenol Sinus Severe, TRAVEL BASIXacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Lil Drug Store Products, Inc | 66715-7857 |
| Dimetapp Nighttime Cold and Coughdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/10mL | SolutionOral | Foundation Consumer Healthcare | 69536-345 |
| Rompe Tos X Childrenacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 250 mg/10mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-784 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Lidl US LLC | 71141-180 |
| Basic Care Daytime Cold and Fluacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-994 |
| Daytime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-303 |
| MGC Health Cough Drops Honey Lemon Flavormenthol | Menthol 7.5 mg/1 | LozengeOral | Medical Group Care LLC | 83173-101 |
| Daytime Cold and Fluacetaminophen dextromethorphan hbr phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-167 |
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