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Cold and Flu Day, Night Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl Kit

by Walgreen Company · 1 KIT in 1 CARTON (0363-1213-99) * 355 mL in 1 BOTTLE, PLASTIC (0363-9912-02) * 355 mL in 1 BOTTLE, PLASTIC (0363-9913-02)
NDC 00363-1213-99
🏷️ FDA NDC (as labeled) 0363-1213-99 billing pads the labeler segment with a zero
This package
Contains1 kit in 1 carton * 355 mL in 1 bottle, plastic * 355 mL in 1 bottle, plastic Pack sizes2 compare ↓
Also comes in: 1 kit 00363-1213-02
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) 0363-1213-99
Product NDC 0363-1213
11-digit billing NDC 00363121399
Application # M012
SPL Set ID 937b481a-e0b7-4d34-a8a1-0bfb2b867c2b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-14
Marketing end 2027-07-31
Dosage form KIT
Why two NDCs? The FDA registers this code as 0363-1213-99 — 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 → 00363-1213-99. 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 marketedNov 2022
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

📖 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 combination kit containing separate day and night formulas to treat multiple cold and flu symptoms. The day formula contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a nasal decongestant). The night formula adds doxylamine succinate, which is a sleep aid. Together, these ingredients are commonly used to help manage daytime and nighttime cold and flu symptoms like aches, fever, cough, and nasal congestion.

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 orange / red
FlavorCherry
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.

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.

💲 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: 1 kit
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, Nightthis 00363-1213-99 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 flu 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
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

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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 Cold and Flu Day, Night (this brand).

Top reported reactions

Chest Pain1
Device Difficult To Use1
Disease Progression1
Eye Pain1
Fatigue1
Headache1
Nasal Congestion1

Age at onset

Adult1
Elderly1

Reporter sex

5 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3 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
00363-1213-02 1 KIT in 1 PACKAGE (0363-1213-02) * 355 mL in 1 BOTTLE, PLASTIC (0363-9912-02) * 355 mL in 1 BOTTLE, PLASTIC (0363-9913-02) 2022-11-14 Active
00363-1213-99 You're viewing this 1 KIT in 1 CARTON (0363-1213-99) * 355 mL in 1 BOTTLE, PLASTIC (0363-9912-02) * 355 mL in 1 BOTTLE, PLASTIC (0363-9913-02) 2022-11-14 Active

Pack size FAQ

What quantity is in NDC 00363-1213-99?
NDC 00363-1213-99 is listed by the FDA — 1 kit in 1 carton * 355 ml in 1 bottle, plastic * 355 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Cold and Flu Day, Night Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl Kit?
Bill NDC 00363-1213-99 — the 11-digit billing format is 00363121399. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 0363-1213-99, 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: 00363-1213-99, written without dashes as 00363121399. 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 00363-1213-99, the first segment (00363) is the labeler code FDA assigned to Walgreen Company; the middle segment (1213) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) 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 it is currently marketed — but Walgreen Company has reported a marketing end date of 2027-07-31, after which this package is expected to stop being marketed. 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 1 kit (00363-1213-02). 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.

📄 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 58 words

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

Uses temporarily relieves common cold and flu symptoms: headache minor aches and pains sore throat runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever

⏱️ Dosage and Administration 97 words

Directions do not take more than directed do not exceed 4 doses per 24 hours mL = milliliter only use the dose cup provided adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children under 6 years do not use

Directions do not take more than directed do not exceed 4 doses per 24 hours mL = milliliter only use the dose cup provided adults and children 12 years and over: 30 mL every 6 hours children under 12 years: do not use

⚠️ Warnings ~3 min read

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 the user has high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) liver disease persistent or chronic cough such as occurs with smoking, asthma, or emphysema heart disease diabetes thyroid disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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.

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 difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sed…

📦 Storage and Handling 48 words

Other information each 15 mL contains: sodium 13 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Other information each 30 mL contains: sodium 13 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

🧪 Active Ingredient 36 words

Active ingredients (in each 15 mL) (Day) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Active ingredients (in each 30 mL) (Night) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

🧪 Inactive Ingredients 61 words

Inactive ingredients anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose

🎯 Purpose 15 words

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

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.