Over-the-counter drug · OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night NDC 0280-0086
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate · Kit · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-0086-01 | 00280008601 | 1 KIT in 1 CARTON (0280-0086-01) * 1 TABLET, EFFERVESCENT in 1 POUCH * 1 TABLET, EFFERVESCENT in 1 POUCHMarketed from Apr 29, 2022 |
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 Severe Cold PowerFast Fizz Day and Night
- Generic name (nonproprietary)
- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate
- Dosage form
- Kit
- 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
- Identifiers
- Product ID 0280-0086_45264f80-a094-86cf-e063-6394a90acb95SPL ID 45264f80-a094-86cf-e063-6394a90acb95SPL set ID d7711cd6-5058-548d-e053-2a95a90ac54dRxCUI 1536498, 2565491, 2565492UPC 0016500594604
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
N400280008601followed by a unit qualifier and the quantityPackage 00280-0086-01. 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 symptoms due to a cold with cough: minor aches and pains headache sinus congestion and pressure cough sore throat nasal congestion temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0280-0086
- What is NDC 0280-0086?
- 0280-0086 is the product NDC for Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night kit, 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 Severe Cold PowerFast Fizz Day and Night (Aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate).
- 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 Severe Cold PowerFast Fizz Day and Night?
- 3 other product NDCs are listed under this name. See all Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night 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 Severe Cold PowerFast Fizz Day and Night 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 Severe Cold PowerFast Fizz Day and Nightaspirin, dextromethorphan hydrobromide, phenylephrine bitartrate | — | KitOral | Bayer HealthCare LLC. | 0280-0069 | 00280-0069-01 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Nightaspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | — | KitOral | Bayer HealthCare LLC. | 0280-0109 | 00280-0109-01 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Nightaspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate | — | Kit | Bayer HealthCare LLC. | 0280-0110 | 00280-0110-01 |
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 |
|---|---|---|---|---|
| Daytime Cold And Flu Relief Softgels Non-Drowsyacetaminophen, dextromethorphan hbr, phenylephrine | Dextromethorphan hydrobromide 10 mg/1 + 2 more ingredients | Capsule, Gelatin coatedOral | Advanced Rx LLC | 80513-301 |
| Sinus plus Headacheacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-094 |
| Halls Honey Vanillamenthol | Menthol 2.5 mg/1 | LozengeOral | Mondelez Global LLC | 12546-338 |
| NyQuil Severe plus Vicks VapoCool Cold and Fluacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide | Dextromethorphan hydrobromide 10 mg/1 + 3 more ingredients | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 37000-523 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-229 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Richmond Pharmaceuticals, Inc. | 54738-115 |
| SanaTos Mucus Relief Cold Toddlersdextromethorphan hbr, guaifenesin | Guaifenesin 50 mg/2.5mL; Dextromethorphan hydrobromide 2.5 mg/2.5mL | LiquidOral | Pharmadel LLC | 55758-307 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Nightacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin | — | KitOral | Bayer HealthCare LLC. | 0280-0506 |
| Cough and Cold HBPchlorpheniramine maleate, dextromethorphan hbr | Chlorpheniramine maleate 4 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Film coatedOral | Valu Merchandisers Company | 63941-989 |
| Cough and Cold XL3 Xtraacetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride | Acetaminophen 250 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Selder, S.A. de C.V. | 63654-800 |
| Nasal Spray, 24-7 for Lifeoxymetazoline hydrochloride 0.05% | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Lil' Drug Store Products, Inc. | 66715-5626 |
| severe cold and cough daytimeacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 650 mg/1 + 2 more ingredients | Powder, For solutionOral | RARITAN PHARMACEUTICALS INC | 68163-540 |
| dimaphen dmbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL + 2 more ingredients | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8134 |
| Daytime Cold and Flu Non drowsyacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | Harris Teeter, LLC | 69256-466 |
| Vicks DayQuil and Vicks NyQuil COLD and FLUacetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate | — | Kit | The Procter & Gamble Manufacturing Company | 69423-996 |
| leader tussin dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | SolutionOral | Cardinal Health 110, LLC. dba Leader | 70000-0596 |
| RIGHT REMEDIES Mucus Relief DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strive Pharmaceuticals Inc. | 70692-181 |
| SEVERE CONGESTION and COUGH MAXdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 2 more ingredients | LiquidOral | AptaPharma Inc. | 76281-517 |
| PurgenLabs Acetaminophenactaminophen | Acetaminophen 500 mg/15mL | LiquidOral | Advanced Rx LLC | 80513-230 |
| Coricidin HBP Cold and Fluacetaminophen and chlorpheniramine maleate | Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1 | Tablet, Film coatedOral | Bayer HealthCare LLC. | 11523-4325 |
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