Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution, 355 mL — NDC 0363-0401-40 (Billing 00363-0401-40)
This is a package of 355 mL of Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution from Walgreen Company, marketed since Aug 2011 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0363-0401-40 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0363 labeler · 0401 product · 40 package
- Package marketed since
- Aug 8, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0363040140 8
- FDA record last changed
- Aug 27, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1043400
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
This is an oral liquid solution sold over the counter as a cold and flu remedy. It contains acetaminophen, which is typically used to reduce fever and relieve pain, along with dextromethorphan, a cough suppressant commonly used to reduce coughing. The product also contains doxylamine succinate, an antihistamine typically used to help relieve congestion and promote drowsiness. This is an OTC monograph product, meaning it is marketed under FDA's established rules for its drug category.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 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 mL | 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 5, 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 |
|---|---|---|---|---|
| 00363-0401-34 0363-0401-34 Main listing | 237 mL in 1 BOTTLE | 2012-08-15 | — | Discontinued by firm |
| 00363-0401-40 You're viewing this | 355 mL in 1 BOTTLE | 2011-08-08 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00363-0401-34?
What NDC number is used to bill for this package of Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Solution?
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 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 5, 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.
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 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing
⏱️ Dosage and Administration ▾
Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
⚠️ Warnings ▾
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • pain or cough 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 • cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information • each 30 mL contains: sodium 35mg • store at 20-25°C (68-77°F)
🧪 Active Ingredient ▾
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
🎯 Purpose ▾
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
📄 Do Not Use ▾
Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
📄 When Using This Product ▾
When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if • pain or cough 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 • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📄 Questions or Comments ▾
Questions? 1-800-719-9260
📄 Package Label / Principal Display Panel ▾
Package/Label Principal Display Panel Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredients in Vicks ® NyQuil ® NIGHTTIME Cold & Flu ACETAMINOPHEN / ACHES / FEVER / SORE THROAT DEXTROMETHORPHAN HBr / COUGH DOXYLAMINE SUCCINATE / SNEEZING / RUNNY NOSE Multi-Symptom • Pain reliever, fever reducer, cough suppressant & antihistamine • ALCOHOL 10% 12 FL OZ (355 mL) 335-94-nighttime-cold-and-flu.jpg
About this NDC listing & data coverage
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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. |