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Cold and Flu Daytime, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl Kit — NDC 0363-6406-08 (Billing 00363-6406-08)

by Walgreen Company · 1 KIT in 1 PACKAGE, COMBINATION * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Cold and Flu Daytime, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl Kit from Walgreen Company, marketed since Aug 2015 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00363-6406-08
🏷️ FDA NDC (as labeled) 0363-6406-08 billing pads the labeler segment with a zero
This package
Contains1 kit in 1 package, combination * 8 tablet, film coated in 1 blister pack * 8 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Main listing for product 0363-6406 · Also comes in: 8 tablets 0363-6406-22
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-6406-08
Product NDC 0363-6406
11-digit billing NDC 00363640608
RxCUI 1110988, 1546881, 2634817
Application # M012
SPL Set ID 4d199dc7-253f-48fd-a77d-f8b10f724dd1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-08-01
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1110988
Why two NDCs? The FDA registers this code as 0363-6406-08 — 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 → 00363-6406-08. 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.

Clinical

📖 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 kit contains daytime and nighttime formulations sold as an over-the-counter monograph product for cold and flu symptom relief. The daytime formula typically includes acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant to help thin mucus), and phenylephrine (a decongestant). The nighttime formula replaces the decongestant with doxylamine, a sleep aid, to support rest while addressing similar symptoms. These products are formulated to address multiple cold and flu symptoms at once.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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.
Try another pack size: 8 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00363-6406-22 0363-6406-22 1 KIT in 1 PACKAGE, COMBINATION * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK 2015-08-01 — Active
00363-6406-08 You're viewing this Main listing 1 KIT in 1 PACKAGE, COMBINATION * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK 2015-08-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 package, combination * 8 tablet, film coated in 1 blister pack * 8 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Cold and Flu Daytime, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl Kit?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Daytime, Nighttime Severe Cold and Flu Relief 51316-0647-22 CVS 8 tablets — — FDA listed —
Cold and Flu Daytime, Nighttime, Maximum Strengththis 00363-6406-08 Walgreen 8 tablets — — FDA listed —
daytime nighttime severe cold and flu 00363-0577-02 Walgreen 1 kit — — FDA listed —
Severe Cold and Flu Plus Congestion 63981-0795-81 COSTCO 1 kit — — FDA listed —
daytime nighttime severe cold and flu relief 11822-0328-01 Rite 1 kit — — FDA listed —
Severe Cold and Flu Relief Daytime/Nighttime 55301-0620-08 ARMY 8 tablets — — FDA listed —
basic care daytime severe cold and flu nighttime severe cold and flu 72288-0597-02 Amazon.com 1 kit — — FDA listed —
Goodsense Combo Pack Daytime And Nighttime 00113-5970-02 L. 1 kit — — FDA listed —
Topcare Day Time Nite Time Cold and Flu 36800-0597-02 Topco 1 kit — — FDA listed —
daytime nighttime severe cold and flu 72288-0813-02 Amazon.com 1 kit — — FDA listed —
daytime nighttime severe cold and flu 51316-0474-02 CVS 1 kit — — 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

🏛️
2015
On the market since
Aug 2015
📍
2026
Currently FDA-listed
11 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerWalgreen Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedAug 2015
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.

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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 83 words ▾

Uses temporarily relieves common cold and flu symptoms: minor aches and pains nasal congestion headache fever sore throat sinus congestion and pressure cough due to minor throat and bronchial irritation cough to help you sleep (Nighttime only) runny nose and sneezing (Nighttime only) reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)

⏱️ Dosage and Administration 45 words ▾

Directions do not take more than directed do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

⚠️ Warnings ~2 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 if you have ever had an allergic reaction to this product or any of its ingredients 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. Ask a doctor before use if you have liver disease diabetes high blood pressure glaucoma (Nighttime only) thyroid disease heart disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only) difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time.

📦 Storage and Handling 42 words ▾

Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

🧪 Active Ingredient 49 words ▾

Active ingredients (in each caplet) (Daytime severe cold & flu) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Active ingredients (in each caplet) (Nighttime severe cold & flu) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 85 words ▾

Inactive ingredients (Daytime only) corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Nighttime only) black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

🎯 Purpose 18 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

📄 Do Not Use 95 words ▾

Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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.

📄 Ask a Doctor Before Use If 75 words ▾

Ask a doctor before use if you have liver disease diabetes high blood pressure glaucoma (Nighttime only) thyroid disease heart disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only) difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only)

📄 When Using This Product 49 words ▾

When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 54 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 116 words ▾

Principal Display Panel DAY & NIGHT PACK Walgreens • WALGREENS • PHARMACIST RECOMMENDED † Compare to the active ingredients in Vicks ® DayQuil ® VapoCOOL ® SEVERE COLD & FLU + CONGESTION and Vicks ® NyQuil ® VapoCOOL ® SEVERE COLD & FLU + CONGESTION †† DAYTIME Severe Cold & Flu ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT GUAIFENESIN / EXPECTORANT PHENYLEPHRINE HCl / NASAL DECONGESTANT Maximum Strength 16 CAPLETS ACTUAL SIZE NIGHTTIME Severe Cold & Flu ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT DOXYLAMINE SUCCINATE / ANTIHISTAMINE PHENYLEPHRINE HCl / NASAL DECONGESTANT Maximum Strength 8 CAPLETS ACTUAL SIZE 24 TOTAL CAPLETS Walgreens 44-640677 Walgreens 44-640677

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 — Not published for this NDC No photo available yet for this listing.
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.
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 8 tablets (00363-6406-22). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 00363-6350-98 · WALGREEN 00363-6450-14 · Walgreen →
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.