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Multi Symptom Severe Cold and Nighttime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl Kit — NDC 00363-5480-12 package photo

Multi Symptom Severe Cold and Nighttime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl Kit

by WALGREEN CO. · 1 KIT in 1 CARTON (0363-5480-12) * 6 PACKET in 1 CARTON (0363-5479-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0363-5481-06) / 1 POWDER, FOR SOLUTION in 1 PACKET
NDC 00363-5480-12
🏷️ FDA NDC (as labeled) 0363-5480-12 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0363-5480-12
Product NDC 0363-5480
11-digit billing NDC 00363548012
NCPDP billing unit EA — each (per item)
RxCUI 1189316, 1659960, 2640034
Application # M013
SPL Set ID 6c4ab613-a587-4ec4-9986-f1d000bc2d23
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-22
Dosage form KIT
Why two NDCs? The FDA registers this code as 0363-5480-12 — 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 → 00363-5480-12. 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 CO.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedJun 2018
Product typeHuman Otc Drug
Portfolio132 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 kit contains over-the-counter oral medications for cold and cough relief, marketed under FDA's OTC monograph rules. Acetaminophen is typically used to reduce fever and relieve aches and pain. Dextromethorphan is a cough suppressant commonly found in cold products. Diphenhydramine is an antihistamine that may help with congestion and sneezing, and also has a sedating effect often used in nighttime formulas. Phenylephrine is a nasal decongestant typically used to relieve sinus and nasal congestion.

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.

🧪 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 sectioncitric acid, caramel, flavors, maltodextrin, potassium chloride, silica,sucralose, sucrose citric acid, F D & C yellow #6, flavors, maltodextrin, potassium chloride, silica,sucralose, sucrose,

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
daytime severe cold and cough and nighttime severe cold and cough 11673-0542-12 Target 1 kit — — FDA listed —
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 58933-0542-16 Procter 1 kit — — FDA listed —
Multi Symptom Severe Cold and Nighttime Severe Cold and Coughthis 00363-5480-12 WALGREEN 1 kit — — FDA listed —
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough 49035-0948-12 WAL-MART 1 kit — — FDA listed —
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough 59779-0768-12 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

🏛️
2018
On the market since
Jun 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00363-5480-12 You're viewing this 1 KIT in 1 CARTON (0363-5480-12) * 6 PACKET in 1 CARTON (0363-5479-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0363-5481-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 2018-06-22 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 0363-5480-12, 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: 00363-5480-12, written without dashes as 00363548012. 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 00363-5480-12, the first segment (00363) is the labeler code FDA assigned to WALGREEN CO.; the middle segment (5480) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 CO.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WALGREEN CO. 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 91 words ▾

Uses - Multi Symptom Severe Cold temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Uses - Nighttime Severe Cold and Cough temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

⏱️ Dosage and Administration ~1 min read ▾

Directions – Multi Symptom Severe Cold do not use more than directed take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age One packet Children under 12 years of age Do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat Directions Nighttime Severe Cold and Cough do not use more than directed take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose Adults and Children 12 years of age and over One packet Children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot.

Consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Directions Nighttime Severe Cold and Cough do not use more than directed take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose Adults and Children 12 years of age and over One packet Children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

⚠️ Warnings 109 words ▾

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough 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.

📦 Storage and Handling 47 words ▾

Other information - Multi Symptom Severe Cold each packet contains: potassium 6 mg store at room temperature. Protect from excessive heat and moisture.

Other information - Nighttime Severe Cold and Cough each packet contains: potassium 6 mg store at room temperature. Protect from excessive heat and moisture

🧪 Active Ingredient 43 words ▾

Active ingredients (in each packet) – Multi Symptom Severe Cold Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Active ingredients (in each packet) - Nighttime Severe Cold and Cough Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients - Multi Symptom Severe Cold citric acid, caramel, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose

Inactive ingredients - Nighttime Severe Cold and Cough citric acid, F D & C yellow #6 , flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,

🎯 Purpose 27 words ▾

Purpose - Multi Symptom Severe Cold Pain reliever/fever reducer Cough Suppressant Nasal Decongestant

Purpose - Nighttime Severe Cold and Cough Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00363-5470-06 · WALGREEN 00363-5510-30 · 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.