daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl Kit — NDC 00363-0567-02 package photo

daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl Kit

by Walgreen Company · 1 KIT in 1 CARTON (0363-0567-02) * 355 mL in 1 BOTTLE (0363-0401-40) * 355 mL in 1 BOTTLE (0363-0666-40)
NDC 00363-0567-02
🏷️ FDA NDC (as labeled) 0363-0567-02 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0363-0567-02
Product NDC 0363-0567
11-digit billing NDC 00363056702
NCPDP billing unit ML — per mL (volume)
Application # M012
SPL Set ID 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-09-06
Dosage form KIT
GPI-14 43995904186350
GPI class Cold & Flu Nighttime/Daytime
GCN Seq No 068527
GCN 31327
HICL code 033966
Ingredient (HICL) Dm/Pe/Acetaminophen/Doxylamine
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3P
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1Stgen Antihist-Decon-Analgesic
AHFS code 04:04.04.00
AHFS class Ethanolamine Derivatives
FDB label name DAYTIME-NIGHTTIME COLD-FLU LIQ
FDB brand name Daytime-Nighttime Cold-Flu
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0363-0567-02 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00363-0567-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerWalgreen Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedSep 2012
Product typeHuman Otc Drug
Portfolio468 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DAYTIME-NIGHTTIME COLD-FLU LIQ Ingredient Dm/Pe/Acetaminophen/Doxylamine
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter kit containing two separate formulations for managing cold and flu symptoms during different times of day. The daytime product contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a nasal decongestant). The nighttime product contains acetaminophen, dextromethorphan, and doxylamine succinate (a sedating antihistamine intended to help with sleep). This kit is marketed under FDA's monograph rules for OTC cold and flu medicines.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Green / Orange
FlavorMenthol
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

From the label’s inactive-ingredient sectionalcohol, 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 butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

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?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
foster and thrive daytime cold and flu relief nighttime cold and flu relief 70677-1028-01 Strategic 2 capsules $0.151 FDA listed
Goodnow cold flu day relief cold flu night relief 82501-1211-01 Gobrands, 2 capsules FDA listed
Daytime Nighttime Cold Flu Relief 41163-0901-48 United 1 capsule FDA listed
NiteTime DayTime Cold and Flu 41250-0597-02 Meijer 1 kit FDA listed
Daytime Nighttime Cold and Flu Relief Multi-Symptom 67091-0336-48 WinCo 16 capsules FDA listed
Cold and Flu Day, Night 00363-1213-02 Walgreen 1 kit FDA listed
daytime nighttime cold and flu 00363-1733-02 Walgreen 1 kit FDA listed
Daytime Nighttime Cold Flu Relief 72476-0850-48 Care 16 capsules FDA listed
Daytime Nighttime Cold Flu Relief 11822-0851-04 Rite 8 capsules FDA listed
Daytime Nighttime Cold Flu Relief 21130-0058-48 Safeway, 16 capsules FDA listed
equaline daytime and nighttime cold and flu relief 41163-0567-02 United 1 kit FDA listed
equate daytime cold and flu nighttime cold and flu 49035-0718-02 Wal-Mart 1 kit FDA listed
Cold and Flu Daytime, Nighttime, Multi-Symptom 00363-9012-48 Walgreens 8 capsules FDA listed
Vicks DayQuil NyQuil ULTRA CONCENTRATED COLD and FLU 69423-0802-96 The 1 kit FDA listed
Topcare Nite Time Day Time Cold and Flu 36800-0580-72 Topco 2 capsules FDA listed
Daytime Nighttime Cold Flu Relief 68016-0799-48 Chain 1 capsule Discontinued
Cold And Flu Daytime-Nighttime 11673-0984-24 TARGET 8 capsules FDA listed
Daytime Nighttime Cold Flu Relief 49035-0192-48 EQUATE 16 capsules FDA listed
Daytime Nighttime Cold Flu Relief 69256-0901-48 Harris 1 capsule FDA listed
basic care daytime nighttime cold and flu 72288-0733-02 Amazon.com 1 kit FDA listed
Daytime Nighttime Cold Flu Relief 72476-0901-48 Care 32 capsules FDA listed
Daytime Nighttime Cold Flu Relief 55319-0566-24 Family 1 capsule FDA listed
Daytime Nighttime Cold Flu Relief 67091-0393-48 WinCo 1 capsule FDA listed
Severe Cold and Flu 00363-1597-02 Walgreen 1 kit FDA listed
Cold and Flu Daytime, Nighttime, Multi-Symptom 00363-9011-24 Walgreens 8 capsules FDA listed
Daytime Nighttime Cold Flu Relief 69842-0852-24 CVS 1 capsule FDA listed
Daytime Nighttime Cold Flu Relief 81522-0901-48 FSA 1 capsule FDA listed
Daytime Nighttime Cold Flu Relief 21130-0901-48 Safeway, 16 capsules FDA listed
TopCare Day Time Nite Time Cold and Flu Relief 36800-0301-02 Topco 1 kit FDA listed
Daytime Nighttime Cold and Flu Relief Multi-Symptom 59726-0901-24 P 8 capsules FDA listed
daytime nighttime cold and fluthis 00363-0567-02 Walgreen 1 kit FDA listed
Daytime Nighttime Cold Flu Relief 69842-0896-24 CVS 1 capsule FDA listed
basic care daytime cold and flu nighttime cold and flu 72288-0580-72 Amazon.com 2 capsules FDA listed
Cold and Flu Daytime Nighttime 51316-0123-02 CVS 1 kit FDA listed
Topcare Day Time Nite Time Cold and Flu 36800-0597-02 Topco 1 kit FDA listed
Daytime Nighttime Cold Flu Relief 41163-0850-48 United 16 capsules FDA listed
Daytime-Nighttime Severe Cold And Flu 41226-0627-24 KROGER 4 capsules FDA listed
daytime nitetime cold and flu 41250-0733-02 Meijer 1 kit FDA listed
dg health cold and flu relief 55910-0811-72 Dolgencorp 2 capsules FDA listed
Severe Nighttime Severe Daytime 59779-0597-02 CVS 1 kit FDA listed
Severe Cold and Flu Nighttime Daytime 42507-0597-02 HyVee 1 kit FDA listed
Daytime Nighttime Cold And Flu 72288-0791-02 Amazon.com 1 kit FDA listed
Good Sense Daytime Nighttime Cold And Flu 00113-5800-72 L. 2 capsules FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2012
On the market since
Sep 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate and Phenylephrine HCl Liquid Filled Capsules — the ingredient across all brands.

Top reported reactions

Dizziness2
Blindness Transient1
Paraesthesia1
Paralysis1
Sleep Disorder1

Reporter sex

2 reports
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00363-0567-02 You're viewing this 1 KIT in 1 CARTON (0363-0567-02) * 355 mL in 1 BOTTLE (0363-0401-40) * 355 mL in 1 BOTTLE (0363-0666-40) 2012-09-06 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0363-0567-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00363-0567-02, written without dashes as 00363056702. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00363-0567-02, the first segment (00363) is the labeler code FDA assigned to Walgreen Company; the middle segment (0567) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Walgreen Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreen Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 64 words

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

Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

⏱️ Dosage and Administration 119 words

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

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 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

⚠️ Warnings ~3 min read

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 • a sodium-restricted diet 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.

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating du…

📦 Storage and Handling 30 words

Other information • each 30 mL contains: sodium 38 mg • store at 20-25°C (68-77°F)

Other information • each 15 mL contains: sodium 7 mg • store at 20-25°C (68-77°F)

🧪 Active Ingredient 42 words

Nighttime Cold & Flu Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Daytime Cold & Flu Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 60 words

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

Inactive ingredients butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

🎯 Purpose 15 words

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.