Alka-Seltzer Plus Cold Day and Night Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate Kit — NDC 0280-1550-20 (Billing 00280-1550-20)
This is a package of Alka-Seltzer Plus Cold Day and Night Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate Kit from Bayer HealthCare LLC., marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0280-1550-20 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0280 labeler · 1550 product · 20 package
- Package marketed since
- Sep 14, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0016500572633
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1536498
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Platelet Aggregation Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
Aspirin is used to: reduce fever relieve mild to moderate pain and inflammation prevent heart attacks, strokes or mini-strokes reduce the risk of death in people who are experiencing or who have had a heart attack Aspirin is in a group of medications called salicylates. It works by blocking natural substances that cause fever, pain, swelling, and blood clots. Aspirin is also available in combination with other medications such as pain relievers and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product,...
Read the full MedlinePlus article ↗This is an over-the-counter combination kit containing day and night formulations taken by mouth. Aspirin is commonly used as a pain reliever and fever reducer. Dextromethorphan is typically used to reduce cough, while phenylephrine is commonly used as a nasal decongestant. Doxylamine is an antihistamine-type ingredient often used to help relieve cold and allergy symptoms. This product is regulated under the FDA's OTC monograph system for cold and cough medicines.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00280-1550-20 You're viewing this Main listing | 1 KIT in 1 CARTON * 6 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH * 4 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH | 2018-09-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Cold Day and Nightthis 00280-1550-20 | Bayer | 2 tablets | — | — | FDA listed | — |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz 00280-0025-01 | Bayer | 12 tablets | — | — | FDA listed | — |
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve 00280-8287-24 | Bayer | 2 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Bayer HealthCare LLC. labeler code 00280
- Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE 325 mg; 2 mg; 7.8 mg Tablet, Effervescent NDC 0280-1400-32
- Aspirin, Dextromethorphan hydrobromide, and Phenylephrine bitartrate 325 mg; 10 mg; 7.8 mg Tablet, Effervescent NDC 0280-1410-32
- Aspirin, Doxylamine succinate, Phenylephrine bitartrate, and Dextromethorphan hydrobromide 500 mg; 6.25 mg; 7.8 mg; 10 mg Tablet, Effervescent NDC 0280-1430-32
- Alka-Seltzer Plus Cold Orange Zest Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate 325 mg; 2 mg; 7.8 mg Tablet, Effervescent NDC 0280-1510-20
- Alka-Seltzer Plus Cold Sparkling Original Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate 325 mg; 7.8 mg; 2 mg Tablet, Effervescent NDC 0280-1520-04
- Alka-Seltzer Plus Cold Night Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate 500 mg; 10 mg; 6.25 mg; 7.8 mg Tablet, Effervescent NDC 0280-1545-20
- Alka-Seltzer Plus Cold and Cough Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate 325 mg; 2 mg; 10 mg; 7.8 mg Tablet, Effervescent NDC 0280-1555-20
- Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride 2 mg; 5 mg; 10 mg; 325 mg Capsule, Liquid Filled NDC 0280-1570-10
- Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride Kit NDC 0280-1580-20
- Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride Kit NDC 0280-1581-40
- Alka-Seltzer Plus Maximum Strength Day Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 325 mg; 10 mg; 5 mg Capsule, Liquid Filled NDC 0280-1590-20
- Alka-Seltzer Plus Maximum Strength Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride 10 mg; 325 mg; 6.25 mg; 5 mg Capsule, Liquid Filled NDC 0280-1600-20
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses •temporarily relieves these symptoms due to a cold with cough: • minor aches and pains • headache • cough • nasal and sinus congestion • sore throat • temporarily reduces fever
Uses Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • headache • runny nose • sinus congestion and pressure • cough • sneezing • sore throat • nasal congestion • temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use
Directions Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use
⚠️ Warnings ▾
Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: ● hives ● facial swelling ● asthma (wheezing) ● shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: ● hives ● facial swelling ● asthma (wheezing) ● shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
🧪 Active Ingredient ▾
Active ingredients (in each tablet) Aspirin 325 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug
Active ingredients (in each tablet) Aspirin 500 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug
🧪 Inactive Ingredients ▾
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate
🎯 Purpose ▾
Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
📄 Do Not Use ▾
Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age
Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if ● stomach bleeding warning applies to you ● you have a history of stomach problems, such as heartburn ● you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ● you are taking a diuretic ● you have ● asthma ● thyroid disease ● diabetes ● cough with excessive phlegm (mucus) ● difficulty in urination due to enlargement of the prostate gland ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a sodium-restricted diet
Ask a doctor before use if ● stomach bleeding warning applies to you ● you have a history of stomach problems, such as heartburn ● you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ● you are taking a diuretic ● you have ● asthma ● diabetes ● thyroid disease ● glaucoma ● cough with excessive phlegm (mucus) ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a sodium-restricted diet
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are ● taking a prescription drug for ● gout ● diabetes ● arthritis
Ask a doctor or pharmacist before use if you are taking a prescription drug for • gout • diabetes • arthritis • taking sedatives or tranquilizers
📄 When Using This Product ▾
When using this product do not exceed recommended dosage
When using this product ● do not exceed recommended dosage may cause marked drowsiness ● avoid alcoholic drinks ● alcohol, sedatives, and tranquilizers may increase drowsiness ● be careful when driving a motor vehicle or operating machinery ● excitability may occur, especially in children
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if ● an allergic reaction occurs. Seek medical help right away. ● you experience any of the following signs of stomach bleeding ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ● pain, cough, or nasal congestion gets worse or lasts more than 7 days ● fever gets worse or lasts more than 3 days ● redness or swelling is present ● new symptoms occur ● ringing in the ears or loss of hearing occurs ● cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition. ● nervousness, dizziness, or sleeplessness occurs
Stop use and ask a doctor if ● an allergic reaction occurs. Seek medical help right away. ● you experience any of the following signs of stomach bleeding ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ● pain, cough, or nasal congestion gets worse or lasts more than 7 days ● fever gets worse or lasts more than 3 days ● redness or swelling is present ● new symptoms occur ● ringing in the ears or loss of hearing occurs ● cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition. ● nervousness, dizziness, or sleeplessness occurs
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Other Information ▾
Other information Other information ● each tablet contains: sodium 416 mg ● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet ● store at room temperature. Avoid excessive heat
Other information Other information ● each tablet contains: sodium 476 mg ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet ● store at room temperature. Avoid excessive heat.
📄 Questions or Comments ▾
Questions or comments ? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Questions or comments? Questions or comments? 1-800-986-0369 (Mon- Fri 9AM – 5PM EST)
📄 Package Label / Principal Display Panel ▾
Package Display Label Alka-Seltzer PLUS® DAY NON-DROWSY ASPIRIN (NSAID) / Pain Reliever-Fever Reducer Dextromethorphan HBr / Cough Suppressant Phenylephrine Bitartrate / Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Sore Throat Sinus Pressure 12 EFFERVESCENT TABLETS NIGHT ASPIRIN (NSAID) / Pain Reliever-Fever Reducer Dextromethorphan HBr / Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine Bitartrate / Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Runny nose Sore Throat 8 EFFERVESCENT TABLETS PDP PDP Carton label
About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |