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Severe Cold and Flu Nighttime Daytime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl Kit — NDC 42507-597-02 (Billing 42507-0597-02)

by HyVee Inc · 1 KIT in 1 CARTON * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE

This is a package of Severe Cold and Flu Nighttime Daytime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl Kit from HyVee Inc, marketed since May 2014 and currently FDA-listed. It is this product's only package size.

NDC 42507-0597-02
🏷️ FDA NDC (as labeled) 42507-597-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42507-597-02
Product NDC 42507-597
11-digit billing NDC 42507059702
RxCUI 1369842, 1431245, 2637731
Application # M012
SPL Set ID d4bcfabb-a054-4f53-8dc9-d361a03558b8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-05-19
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1369842
Why two NDCs? The FDA registers this code as 42507-597-02 — 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 → 42507-0597-02. 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.

Clinical

🧪 What is this product?

This is an over-the-counter kit product containing multiple active ingredients typically used to relieve symptoms of colds and flu, including cough, congestion, and body discomfort. Acetaminophen is commonly included to reduce fever and pain, while dextromethorphan functions as a cough suppressant. Doxylamine succinate is a sleep aid antihistamine often added to nighttime cold formulas, and phenylephrine hydrochloride is a decongestant typically used to relieve nasal congestion. The kit format allows separate daytime and nighttime dosing options.

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.
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
42507-0597-02 You're viewing this Main listing 1 KIT in 1 CARTON * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE 2014-05-19 — Active

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 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 Daytimethis 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

🏛️
2014
On the market since
May 2014
📍
2026
Currently FDA-listed
12 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

LabelerHyVee Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code42507
First marketedMay 2014
Product typeHuman Otc Drug
Portfolio137 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 145 words ▾

Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage

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

⏱️ 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 4 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 • heart disease • high blood pressure • thyroid disease • diabetes • 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 such 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 • do not use more than directed • 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 • you get nervous, dizzy or sleepless • 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.

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… [Excerpted — this section continues on DailyMed.]

📦 Storage and Handling 41 words ▾

Other information • each 30 mL contains: sodium 41 mg • store at 20-25 ° C (68-77 ° F)

Other information • each 15 mL contains: sodium 15 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate.

🧪 Active Ingredient 41 words ▾

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 66 words ▾

Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum Questions or comments? 1-800-289-8343

Inactive ingredients anhydrous citric acid, FD&C yellow #6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

🎯 Purpose 18 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 196 words ▾

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

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 126 words ▾

Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • 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 such as occurs with smoking, asthma, or emphysema • a sodium-restricted diet

Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 38 words ▾

Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 When Using This Product 56 words ▾

When using this product • do not use more than directed • 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

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 141 words ▾

Stop use and ask a doctor if • you get nervous, dizzy or sleepless • 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.

Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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 20 words ▾

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

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

📄 Keep Out of Reach of Children 92 words ▾

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.

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.

📄 Questions or Comments 8 words ▾

Questions or comments? 1-800-289-8343

Questions or comments? 1-800-289-8343

📄 Package Label / Principal Display Panel 127 words ▾

Principal Display Panel HyVee® Compare To Vicks® DayQuil® Severe and NyQuil® Severe Active Ingredients COMBO PACK DAYTIME & NIGHTTIME Severe Cold & Flu Daytime • Non-Drowsy Acetaminophen Pain Reliever/Fever Reducer Guaifenesin Expectorant Phenylephrine HCl Nasal Decongestant Dextromethorphan HBr Cough Suppressant Original Flavor • Headache • Fever, Sore Throat • Minor Aches & Pains • Chest Congestion • Nasal/Sinus Congestion • Sinus Pressure • Cough ALCOHOL FREE 12 FL OZ (355 mL) Severe Cold & Flu Nighttime • Max Strength Acetaminophen Pain Reliever/Fever Reducer Phenylephrine HCl Nasal Decongestant Doxylamine Succinate Antihistamine Dextromethorphan HBr Cough Suppressant Berry Flavor • Headache • Fever, Sore Throat • Minor Aches & Pains • Nasal/Sinus Congestion & Sinus Pressure • Sneezing, Runny Nose • Cough ALCOHOL FREE 12 FL OZ (355 mL) hyvee-severe-cold-&-flu-container-image.jpg

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

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, phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Dyspnoea3
Vomiting3
Chills2
Dizziness2
Headache2
Hypersensitivity2
Nasopharyngitis2

Age at onset

Adult1
Elderly1

Reporter sex

23 reports

Serious outcomes

Hospitalization5
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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.

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 HyVee Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HyVee 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.
← 42507-0592-03 · HYVEE 42507-0598-02 · HyVee →
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.