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SEVERE COLD PLUS FLU DAYTIME NIGHTTIME Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate Kit

by CVS Pharmacy,Inc. · 1 KIT in 1 CARTON (69842-546-12) * 6 POWDER, FOR SOLUTION in 1 CARTON * 6 POWDER, FOR SOLUTION in 1 CARTON
NDC 69842-0546-12
🏷️ FDA NDC (as labeled) 69842-546-12 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 69842-546-12
Product NDC 69842-546
11-digit billing NDC 69842054612
RxCUI 1534835, 1550968, 1804384
Application # M012
SPL Set ID 6cb1d08b-e544-4084-b9ed-1e0d99a709c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-14
Dosage form KIT
Why two NDCs? The FDA registers this code as 69842-546-12 — a 5-3-2 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 product segment → 69842-0546-12. 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

LabelerCVS Pharmacy,Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69842
First marketedJul 2017
Product typeHuman Otc Drug
Portfolio27 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

🧪 What is this product?

This is an over-the-counter kit containing daytime and nighttime formulations to address multiple cold and flu symptoms. The daytime formula contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant that helps thin mucus), and phenylephrine (a nasal decongestant). The nighttime formula adds doxylamine succinate, which is a sleep aid antihistamine. Together, these ingredients are typically used to manage various cold and flu symptoms including aches, fever, cough, congestion, and runny nose.

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 sectionanhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

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
Vicks DayQuil and Vicks NyQuil Severe Cold and Flu 37000-0814-24 The 1 kit — — FDA listed —
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night 00280-8284-12 Bayer 1 kit — — FDA listed —
Severe Cold Plus Flu Daytime Nighttimethis 69842-0546-12 CVS 1 kit — — FDA listed —
Vicks DayQuil and Vicks NyQuil Severe Cold and Flu 37000-0045-24 The 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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 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 hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate — the ingredient across all brands.

Top reported reactions

Chest Pain1
Hypertension1
Product Label Confusion1

Reporter sex

0 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization1
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
69842-0546-12 You're viewing this 1 KIT in 1 CARTON (69842-546-12) * 6 POWDER, FOR SOLUTION in 1 CARTON * 6 POWDER, FOR SOLUTION in 1 CARTON 2017-07-14 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 — Not published for this NDC No photo available yet for this listing.
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 69842-546-12, 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: 69842-0546-12, written without dashes as 69842054612. 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 69842-0546-12, the first segment (69842) is the labeler code FDA assigned to CVS Pharmacy,Inc.; the middle segment (0546) 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 CVS Pharmacy,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Pharmacy,Inc. 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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 94 words ▾

Uses ▪ temporarily relieves these symptoms due to a cold or flu: ▪ minor aches and pains ▪ headache ▪ sore throat ▪ cough ▪ nasal congestion ▪ sinus congestion and pressure ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ▪ temporarily reduces fever

Uses ▪ temporarily relieves these symptoms due to a cold or flu: ▪ headache ▪ minor aches and pains ▪ cough ▪ sore throat ▪ nasal congestion ▪ sinus congestion and pressure ▪ runny nose ▪ sneezing ▪ temporarily reduces fever

⏱️ Dosage and Administration 128 words ▾

Directions ▪ do not take more than the recommended dose ▪ take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor ▪ adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. ▪ children under 12 years: do not use

Directions ▪ do not take more than the recommended dose ▪ take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor ▪ adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. ▪ children under 12 years: do not use

⚠️ Warnings ~3 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 6 packets in 24 hours, which is the maximum daily amount for this product ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma(wheezing) ▪ shock Is a skin or general allergic 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 ▪ in children under 12 years of age Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficulty in urination due to enlargement of the prostate gland ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ cough with excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if ▪ pain, cough, or nasal congestion 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. ▪ nervousness, dizziness, or sleeplessness occurs 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 at 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 you take ▪ more than 5 packets in 24 hours, which is the maximum daily amount for this product ▪ 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 ▪ Hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock Is a skin or general allergic 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 to sedate children. 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 ▪ in chil…

🤒 Adverse Reactions 106 words ▾

ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma(wheezing) ▪ shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away.

ALLERGY ALERT Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away

📦 Storage and Handling 28 words ▾

Other information ▪ each packet contains: potassium 6 mg ▪ store at room temperature

Other information ▪ each packet contains: potassium 6 mg ▪ store at room temperature

🧪 Active Ingredient 57 words ▾

Active ingredients (in each packet) Purposes Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine hydrochloride 10 mg Nasal decongestant

Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine Phenylephrine hydrochloride 10 mg Nasal decongestant

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

Inactive ingredients anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

🎯 Purpose 57 words ▾

Active ingredients (in each packet) Purposes Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine hydrochloride 10 mg Nasal decongestant

Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine Phenylephrine hydrochloride 10 mg Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69842-0543-04 · CVS 69842-0547-10 · CVS →
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.