Over-the-counter drug · OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day Cold and Flu NDC 0280-1590
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride · Acetaminophen 325 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-1590-20 | 00280159020 | 2 BLISTER PACK in 1 CARTON (0280-1590-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 19, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Alka-Seltzer Plus Maximum Strength Day Cold and Flu
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Capsule, Liquid filled
- 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)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0280-1590_45267943-6d50-45dd-e063-6294a90ab025SPL ID 45267943-6d50-45dd-e063-6294a90ab025SPL set ID 5172dc01-4e7f-3307-e054-00144ff8d46cRxCUI 1086997UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0016500555308
- Pharmacologic class
- 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.
- NDC on a medical claim
N400280159020followed by a unit qualifier and the quantityPackage 00280-1590-20. 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 symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0280-1590
- What is NDC 0280-1590?
- 0280-1590 is the product NDC for Alka-Seltzer Plus Maximum Strength Day Cold and Flu, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Bayer HealthCare LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alka-Seltzer Plus Maximum Strength Day Cold and Flu (Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, 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 Maximum Strength Day 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 |
|---|---|---|---|---|
| Equate Kids Daytime Dex Cough Gelsdextromethorphan | Dextromethorphan hydrobromide 10 mg/1 | Tablet, ChewableOral | Walmart | 79903-337 |
| Nuvicare DayTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-018 |
| MGC Cough Dropsmenthol | Menthol, Unspecified form 5.4 mg/1 | LozengeOral | Medical Group Care LLC | 83173-109 |
| Pain Reliever PMacetaminophen diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-166 |
| Cough Dropsmenthol | Menthol 7.5 mg/1 | PastilleOral | United Natural Foods, Inc. | 83455-203 |
| Better Livingphenylephrine hydrochloride | Phenylephrine hydrochloride 1 g/100mL | SprayNasal | BETTER LIVING BRANDS LLC | 21130-728 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytimeacetaminophen, guaifenesin and phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0527 |
| nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | Spray, MeteredNasal | Rite Aid Corporation | 11822-6319 |
| Childrens Sudafed Nasal Decongestantpseudoephedrine hydrochloride | Pseudoephedrine hydrochloride 15 mg/5mL | SolutionOral | Kenvue Brands LLC | 50580-536 |
| Dye Free Wal Dryl Allergy childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Walgreens | 0363-0293 |
| Childrens Giltuss Honey Cough and Chest Congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Dextrum Laboratories, Inc | 65852-003 |
| Severe Sinus Daytime, Non-Drowsyacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Walgreen Company | 0363-5027 |
| Leader Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | Cardinal Health 110,Inc | 70000-0676 |
| Akin Cough Formula DMdextromethorphan, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Southern Sales & Service, Inc. | 69822-202 |
| CVS Health Chest Congestion Relief PEguaifenesin/phenylephrine | Guaifenesin 400 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | CVS Pharmacy, Inc. | 69842-997 |
| Sinus Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-119 |
| Cough Drops Dollar General Assorted Flavors 80ctmenthol | Menthol 2.8 mg/1 | LozengeOral | Dollar General | 75712-042 |
| Mucinex Instasoothe Coughdextromethorphan hydrobromide | Dextromethorphan hydrobromide 5 mg/1 | LozengeOral | Reckitt Benckiser LLC | 72854-267 |
| Rayo Breath Chamomilementhol, camphor | Menthol 1 g/g; Camphor (Synthetic) 1 g/g | CreamTopical | Quimicas Handal de Centroamerica SA de CV | 83033-1620 |
| MGC Healthcough drops cherry | Menthol 5.8 mg/1 | LozengeOral | Medical Group Care LLC | 83173-100 |
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