Home › NDC Lookup › Ingredients › Acetaminophen Dextromethorphan Hbr Guaif... › 55319-0145-08
🧴image loading
(from DailyMed)

Daytime Severe Cold and Flu Relief Acetaminophen Dextromethorphan HBr Guaifenesin, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL Liquid, 237 mL — NDC 55319-145-08 (Billing 55319-0145-08)

by Family Dollar (FAMILY WELLNESS) · 237 mL in 1 BOTTLE, PLASTIC

This is a package of 237 mL of Daytime Severe Cold and Flu Relief Acetaminophen Dextromethorphan HBr Guaifenesin, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL Liquid from Family Dollar (FAMILY WELLNESS), marketed since Jul 2024 and currently FDA-listed. It is this product's only package size.

NDC 55319-0145-08
🏷️ FDA NDC (as labeled) 55319-145-08 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 Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55319-145-08
Product NDC 55319-145
11-digit billing NDC 55319014508
RxCUI 1369842
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID 17640528-c1f7-4881-ba86-bb3f488a952c
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-31
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1369842
Why two NDCs? The FDA registers this code as 55319-145-08 — 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 → 55319-0145-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is a liquid cold and flu relief product taken by mouth. It contains four active ingredients that work together in over-the-counter cold and flu formulations. Acetaminophen is typically used to reduce fever and relieve aches and pain. Dextromethorphan is commonly included to help suppress cough. Guaifenesin functions as an expectorant, meant to help thin mucus. Phenylephrine is a nasal decongestant typically used to help relieve congestion. This product is marketed under FDA's over-the-counter monograph rules for these ingredient categories.

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 mLPer 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
55319-0145-08 You're viewing this Main listing 237 mL in 1 BOTTLE, PLASTIC 2024-07-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
foster and thrive daytime severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 70677-1029-01 Strategic 355 ml $0.013 — FDA listed —
Good Sense Severe Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 00113-0603-34 L. 237 ml $0.018 — FDA listed —
Leader Daytime Severe Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 70000-0192-01 Cardinal 237 ml $0.018 — FDA listed —
Theraflu ExpressMax Severe Cold and Flu Syrup 650 mg/1; 20 mg/1; 400 mg/1; 10 mg 00067-8132-08 Haleon 1 syrup — — FDA listed —
good sense day time cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 00113-2299-40 L. 354 ml — — FDA listed —
Severe Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 00363-0603-34 Walgreen 237 ml — — FDA listed —
Severe Cold and Flu Relief Daytime 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 00363-4150-08 Walgreens 237 ml — — FDA listed —
daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 00363-5001-40 Walgreen 355 ml — — FDA listed —
Daytime Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 400 mg/30mL; 10 mg/30mL 00363-7270-12 WALGREENS 354 ml — — FDA listed —
Daytime Severe Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 11822-0710-01 Rite 355 ml — — FDA listed —
severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 11822-3120-00 Rite 1 bottle — — FDA listed —
Signature Care Non drowsy Daytime Severe Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 21130-0091-40 Safeway 355 ml — — FDA listed —
Cold And Flu Relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 21130-0436-40 Safeway 355 ml — — FDA listed —
daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 30142-0603-40 Kroger 354 ml — — FDA listed —
Daytime Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 400 mg/30mL; 10 mg/30mL 30142-0722-12 The 354 ml — — FDA listed —
Topcare Day Time Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 36800-0603-40 Topco 355 ml — — FDA listed —
Vicks DayQuil Severe Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 37000-0810-01 The 30 ml — — FDA listed —
daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 37808-0603-40 H 355 ml — — FDA listed —
equaline daytime severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 41163-0603-40 United 1 bottle — — FDA listed —
Severe Cold and Flu Daytime Honey 10 mg/15mL; 200 mg/15mL; 5 mg/15mL; 325 mg/15mL 41226-0766-01 Kroger 354 ml — — FDA listed —
Daytime Severe Cold and Flu 5 mg/15mL; 325 mg/15mL; 200 mg/15mL; 10 mg/15mL 41226-0774-01 Kroger 354 ml — — FDA listed —
Severe Cold and Flu Daytime 400 mg/30mL; 10 mg/30mL; 650 mg/30mL; 20 mg/30mL 41226-0780-01 KROGER 354 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 41250-0603-40 Meijer 355 ml — — FDA listed —
Careone daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 41520-0713-40 American 355 ml — — FDA listed —
severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 42507-0511-40 HyVee 355 ml — — FDA listed —
Severe Cold and Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 42507-0603-40 HyVee 355 ml — — FDA listed —
equate daytime cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 49035-0476-40 Wal-Mart 355 ml — — FDA listed —
Severe Cold and Flu Relief Daytime 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 49580-0415-08 P 237 ml — — FDA listed —
Tylenol Cold Plus Flu Severe 650 mg/30mL; 20 mg/30mL; 400 mg/30mL; 10 mg/30mL 50580-0403-08 Kenvue 240 ml — — FDA listed —
TYLENOL Cold Plus Mucus Severe 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 50580-0511-01 Kenvue 240 ml — — FDA listed —
severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 51316-0293-40 CVS 355 ml — — FDA listed —
daytime severe 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 51316-0613-40 CVS 355 ml — — FDA listed —
Daytime Severe Cold And Flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 51316-0681-40 CVS 355 ml — — FDA listed —
CVS Daytime Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 400 mg/30mL; 10 mg/30mL 51316-0727-12 CVS 354 ml — — FDA listed —
Daytime Severe Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mLthis 55319-0145-08 Family 237 ml — — FDA listed —
Severe Cold and Flu Relief Daytime 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 55910-0515-08 Dolgencorp, 237 ml — — FDA listed —
DG Health Cold and Flu Severe 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 55910-0576-40 Dolgencorp 355 ml — — FDA listed —
DG Health Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 55910-0737-34 Dolgencorp 237 ml — — FDA listed —
Daytime Severe 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 59640-0308-40 H 355 ml — — FDA listed —
Severe Daytime 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 59779-0603-34 CVS 237 ml — — Discontinued —
Vicks DayQuil Severe Honey Cold and Flu 325 mg/15mL; 5 mg/15mL; 10 mg/15mL; 200 mg/15mL 69423-0759-06 Procter 177 ml — — FDA listed —
VICKS DayQuil SEVERE HONEY FLAVOR COLD and FLU 325 mg/15mL; 5 mg/15mL; 10 mg/15mL; 200 mg/15mL 69423-0806-08 Procter 236 ml — — FDA listed —
Vicks Formula 44 VapoCool Cough and Chest Congestion 10 mg/30mL; 400 mg/30mL; 20 mg/30mL; 650 mg/30mL 69423-0964-08 The 236 ml — — Discontinued —
DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION 10 mg/30mL; 400 mg/30mL; 20 mg/30mL; 650 mg/30mL 69423-0990-08 The 236 ml — — FDA listed —
basic care daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 72288-0515-40 Amazon.com 355 ml — — FDA listed —
daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 72288-0557-34 Amazon.com 237 ml — — FDA listed —
basic care daytime severe cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 72288-0603-34 Amazon.com 237 ml — — FDA listed —
topcare day time cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 76162-0500-40 Topco 1 bottle — — FDA listed —
daytime cold flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 79481-5100-00 Meijer, 355 ml — — FDA listed —
equate cold and flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 79903-0123-12 WALMART 355 ml — — FDA listed —
Cold and Flu plus Congestion Daytime 650 mg/30mL; 20 mg/30mL; 400 mg/30mL; 10 mg/30mL 79903-0190-12 WALMART 355 ml — — FDA listed —
up and up daytime honey cold flu 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL 82442-0119-40 Target 355 ml — — FDA listed —
Daytime Severe Cold and Flu 5 mg/15mL; 325 mg/15mL; 200 mg/15mL; 10 mg/15mL 85828-0774-01 Grocery 354 ml — — 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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

LabelerFamily Dollar (FAMILY WELLNESS)
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio63 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 69 words ▾

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

⏱️ Dosage and Administration 93 words ▾

Directions take only as directed (see overdose warning) do not take more than 4 doses in any 24 hours measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product adults and children12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) 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 blistere 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 is 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. Ask a doctor before use if the user has 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 as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin When using this product do not take more than directed.

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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: Taking more than the recommended dose can cause serious liver damage.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms

🧪 Active Ingredient 20 words ▾

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

🧪 Inactive Ingredients 25 words ▾

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

🎯 Purpose 9 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 79 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.

📄 Ask a Doctor Before Use If 48 words ▾

Ask a doctor before use if the user has 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 as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin

📄 When Using This Product 10 words ▾

When using this product do not take more than directed.

📄 Stop Use and Ask a Doctor If 66 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 54 words ▾

Keep out of reach of children. Overdose warning: Taking more than the recommended dose can cause serious liver damage.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms

📄 Other Information 16 words ▾

Other information each 15 mL contains: sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 144 words ▾

Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL™ SEVERE COLD & FLU* DAYTIME COLD & FLU RELIEF SEVERE ACETAMINOPHEN 325 mg pain reliever/Fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant Relieves Headache, fever, sore throat, minor aches & pains Chest congestion, thins & loosen mucus Nasal congestion, sinus pressure cough Alcohol-Free FL OZ (mL) *This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks® and DayQuil™ are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY:MIDWOOD BRANDS, LLC 510 VOLVO PKWY, CHESAPEAKE, VA 23320

Product Label FAMILY WELLNESS Daytime Cold & Flu Relief Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

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 Daytime Severe Cold and Flu Relief (this brand).

Top reported reactions

Toxicity To Various Agents2
Anaphylactic Reaction1
Choking1
Erythema1
Heart Rate Increased1
Intentional Product Misuse1
Peripheral Swelling1

Age at onset

Adult2

Reporter sex

6 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2020 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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 Family Dollar (FAMILY WELLNESS). Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Family Dollar (FAMILY WELLNESS) 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.
← 55319-0139-36 · Family 55319-0151-24 · FAMILY →
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.