Over-the-counter drug · OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax NDC 0280-0061
Guaifenesin 200 mg/1 + 3 more ingredients · Capsule, Liquid filled · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0280-0061Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00280-0061Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-0061-01 | 00280006101 | 2 BLISTER PACK in 1 CARTON (0280-0061-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 1, 2020 | |
| 0280-0061-02 | 00280006102 | 2 BLISTER PACK in 1 CARTON (0280-0061-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 1, 2020 |
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 Cough, Mucus and Congestion Powermax
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Active ingredients
- Guaifenesin — 200 mg/1Acetaminophen — 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)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0280-0061_45262b77-58b2-6e5f-e063-6394a90a443cSPL ID 45262b77-58b2-6e5f-e063-6394a90a443cSPL set ID a6a2dd4a-a3c8-2dfa-e053-2995a90ada86RxCUI 1656815UNII 495W7451VQ, 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0016500584209
- 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.
- NDC on a medical claim
N400280006101followed by a unit qualifier and the quantityPackage 00280-0061-01. 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 Uses · helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · minor aches and pains · headache · cough · sore throat · temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0280-0061
- What is NDC 0280-0061?
- 0280-0061 is the product NDC for Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax, Guaifenesin 200 mg/1 + 3 more ingredients capsule, liquid filled, listed with the FDA by Bayer HealthCare LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax (Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride).
- What is the active ingredient?
- Guaifenesin, 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 Cough, Mucus and Congestion Powermax?
- 1 other product NDC are listed under this name. See all Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Nightacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride | — | KitOral | Bayer HealthCare, LLC. | 0280-0062 | 00280-0062-01 |
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 |
|---|---|---|---|---|
| 12 Hour Nasal Decongestant Extra Moisturizingnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-377 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | Sheffield Pharmaceuticals LLC | 11527-140 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-378 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate solution | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | SolutionOral | Lil' Drug Store products, Inc. | 66715-6416 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| 4 Way Fast Actingphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | Haleon US Holdings LLC | 0067-2086 |
| 7 Select Maximum Strengthdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | 7-ELEVEN | 10202-740 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Health Pharma USA LLC | 71679-101 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgacetaminophen, dextromethorphan hbr and phenylephrine hcl | Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0188 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-228 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | — | KitOral | CVS Pharmacy, Inc | 51316-984 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-122 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-322 |
| Acetaminophen, Dextromethorphan HBr | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-036 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | Guaifenesin 200 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0184 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0185 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | — | KitOral | CVS Pharmacy, Inc | 51316-609 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-628 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0154 |
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