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CareOne DayTime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Solution, 355 mL — NDC 41520-0032-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CareOne DayTime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Solution, 355 mL — NDC 41520-032-40 (Billing 41520-0032-40)

by American Sales Company · 355 mL in 1 BOTTLE

This is a package of 355 mL of CareOne DayTime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Solution from American Sales Company, marketed since Apr 2016 and currently FDA-listed.

NDC 41520-0032-40
🏷️ FDA NDC (as labeled) 41520-032-40 billing pads the product segment with a zero
This package
Contains355 mL Pack sizes2 compare ↓
Product page 41520-0032-34 Also comes in: 237 ml 41520-032-34
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

NDC database record

One package, one record: these facts belong to NDC 41520-032-40 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
41520 labeler · 032 product · 40 package
Package marketed since
Sep 18, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4152003240 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41520-032-40
Product NDC 41520-032
11-digit billing NDC 41520003240
RxCUI 1113705
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID c4732df0-e760-4283-98f3-2d08c8cd6a9e
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-12
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1113705
Why two NDCs? The FDA registers this code as 41520-032-40 — 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 → 41520-0032-40. 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?

CareOne DayTime Cold and Flu is an oral liquid solution sold over the counter under FDA's OTC monograph rules. It contains acetaminophen, a pain reliever and fever reducer, combined with dextromethorphan, a cough suppressant, and phenylephrine, a nasal decongestant. This combination is typically used to relieve multiple cold and flu symptoms such as fever, aches, cough, 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.

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.
Try another pack size: 237 ml
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
41520-0032-34 41520-032-34 Main listing 237 mL in 1 BOTTLE 2017-09-18 — Discontinued by firm
41520-0032-40 You're viewing this 355 mL in 1 BOTTLE 2017-09-18 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 355 mL — 355 ml in 1 bottle.
How does this package differ from NDC 41520-0032-34?
Both are CareOne DayTime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Solution — the drug itself is identical. This page's package is the 355 mL one, while NDC 41520-0032-34 is the 237 ml package.
What NDC number is used to bill for this package of CareOne DayTime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 70000-0191-01 Cardinal 237 ml $0.013 — FDA listed —
Good Sense Daytime non drowsy cold and flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 00113-0656-34 L. 237 ml $0.014 — Availability likely —
foster and thrive daytime cold and flu relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 70677-1031-01 Strategic 237 ml $0.014 — Availability likely —
Theraflu ExpressMax Daytime Severe Cold and Cough 650 mg/30mL; 20 mg/30mL; 10 mg/30mL 00067-8127-08 Haleon 245.5 ml — — FDA listed —
Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 00363-0666-34 Walgreen 237 ml — — FDA listed —
Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 00363-4661-12 Walgreens 355 ml — — Discontinued —
Cold and Flu Day 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 00363-9912-02 Walgreen 355 ml — — FDA listed —
Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 00363-9974-08 Walgreens 237 ml — — FDA listed —
Daytime Cold and Flu 5 mg/15mL; 325 mg/15mL; 10 mg/15mL 11673-0765-01 TARGET 354 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 11822-1583-01 Rite 237 ml — — Discontinued —
Day Time Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 21130-0580-08 Safeway, 237 ml — — FDA listed —
Day Time Cold and Flu Relief non drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 21130-0866-08 Safeway, 237 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 5 mg/15mL; 10 mg/15mL 21130-0947-06 BETTER 236 ml — — FDA listed —
Good Neighbor Pharmacy Day Time 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 24385-0005-30 Amerisource 177 ml — — Discontinued —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 30142-0666-12 The 355 ml — — Discontinued —
topcare day time cold and flu relief multi symptom relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 36800-0522-34 Topco 237 ml — — FDA listed —
DayTime 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 37808-0656-38 H 296 ml — — Discontinued —
Daytime Severe Cold and Cough 650 mg/30mL; 20 mg/30mL; 10 mg/30mL 37808-0718-83 H 245 ml — — FDA listed —
Cold and Flu Daytime 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 37835-0526-02 Bi-Mart 355 ml — — FDA listed —
Daytime Cold And Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 37835-0527-12 BI-MART 355 ml — — FDA listed —
equaline daytime cold and flu relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 41163-0656-40 United 355 ml — — FDA listed —
Daytime Cold and Flu 5 mg/15mL; 10 mg/15mL; 325 mg/15mL 41226-0772-01 Kroger 354 ml — — FDA listed —
Daytime cold and flu non drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 41250-0656-40 Meijer 355 ml — — FDA listed —
CareOne DayTime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mLthis 41520-0032-40 American 355 ml — — FDA listed —
Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 42507-0522-40 HyVee 355 ml — — FDA listed —
Daytime Cold and Flu Non drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 49035-0466-12 EQUATE 355 ml — — FDA listed —
equate daytime cold and flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 49035-0726-40 Wal-Mart 355 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 49580-0466-01 P 296 ml — — FDA listed —
Severe Cold and Cough Relief Daytime 650 mg/30mL; 20 mg/30mL; 10 mg/30mL 49580-0501-08 P 245 ml — — FDA listed —
Tukol Honey Daytime Cold and Flu 21.667 mg/mL; .667 mg/mL; .333 mg/mL 50066-0302-04 Genomma 1 bottle — — FDA listed —
Cold and Flu Daytime Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 50844-0251-02 L.N.K. 355 ml — — Discontinued —
daytime cold and flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 51316-0350-34 CVS 1 bottle — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 51316-0466-08 CVS 237 ml — — FDA listed —
Daytime Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 51316-0617-12 CVS 354 ml — — FDA listed —
DAY-TIME Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 53942-0506-28 DeMoulas 354 ml — — FDA listed —
Day-Time COLD/FLU RELIEF 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 53943-0506-28 Discount 354 ml — — FDA listed —
Cold and Flu Daytime 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 55301-0712-02 ARMY 355 ml — — FDA listed —
Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 55319-0646-12 Family 355 ml — — FDA listed —
Daytime Cold and Flu 650 mg/30mL; 20 mg/30mL; 10 mg/30mL 55319-0960-08 Family 245 ml — — FDA listed —
Sanatos Multi Symptom Daytime 10 mg/15mL; 5 mg/15mL; 325 mg/15mL 55758-0055-25 Pharmadel 177 ml — — FDA listed —
Cold and Flu Relief Daytime 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 55910-0366-12 Dolgencorp, 355 ml — — FDA listed —
DG Health Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 55910-0656-34 Dolgencorp 237 ml — — FDA listed —
Severe Cold and Cough Relief Daytime 650 mg/30mL; 20 mg/30mL; 10 mg/30mL 55910-0801-08 Dolgencorp, 245 ml — — FDA listed —
day time non drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 56062-0656-40 Publix 355 ml — — FDA listed —
Daytime Non-Drowsy COLD/FLU 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 57243-0506-25 Salado 177 ml — — FDA listed —
Daytime Non Drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 59779-0656-34 CVS 237 ml — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 63868-0020-08 QUALITY 237 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 63941-0466-06 Best 177 ml — — FDA listed —
Circle K Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 66715-5531-04 Lil' 237 ml — — FDA listed —
Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven 10 mg/15mL; 325 mg/15mL; 5 mg/15mL 66715-6415-04 Lil' 355 ml — — FDA listed —
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven 5 mg/15mL; 10 mg/15mL; 325 mg/15mL 66715-6615-04 Lil' 177 ml — — FDA listed —
Daytime Cold and Flu Lil Drug Store Products 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 66715-6931-04 Lil' 237 ml — — FDA listed —
Cold and Flu Relief Multi symptom 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 67091-0287-54 WinCo 355 ml — — FDA listed —
Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 67091-0471-12 WinCo 355 ml — — FDA listed —
Daytime Cold and Flu Non drowsy 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 69256-0466-12 Harris 355 ml — — FDA listed —
Vicks DayQuil Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 69423-0788-04 The 118 ml — — FDA listed —
Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 71141-0179-32 Lidl 355 ml — — FDA listed —
Basic Care Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 72288-0656-34 Amazon.com 237 ml — — FDA listed —
XL-3 Day Time 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 76281-0304-28 AptaPharma 354 ml — — FDA listed —
XL-3 Day Time 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 76281-0306-25 AptaPharma 177 ml — — FDA listed —
Day-Time Cold/Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 76281-0506-25 AptaPharma 177 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 83324-0167-12 QUALITY 355 ml — — FDA listed —
Cold and Flu Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 83324-0168-08 QUALITY 237 ml — — FDA listed —
Vicks DayQuil Cold and Flu Multi-Symptom Relief 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 84126-0315-04 The 118 ml — — FDA listed —
Revasol Daytime Cold And Flu 10 mg/30mL; 20 mg/30mL; 650 mg/30mL 84379-0275-04 Rnv 118 ml — — FDA listed —
XL-3 Day Time 10 mg/15mL; 325 mg/15mL; 5 mg/15mL 84379-0441-06 Rnv 177 ml — — FDA listed —
Daytime Cold and Flu 5 mg/15mL; 10 mg/15mL; 325 mg/15mL 85828-0772-01 Grocery 354 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 72288-0866-40 Amazon.com 355 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

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 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.

What it looks like

Color Orange
FlavorMenthol
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

14 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesanhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerAmerican Sales Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code41520
First marketedApr 2016
Product typeHuman Otc Drug
Portfolio100 products on file

More NDCs from American Sales Company labeler code 41520

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 📦 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 31 words ▾

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

⏱️ Dosage and Administration 65 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 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 ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if 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, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed 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, 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.

📦 Storage and Handling 19 words ▾

Other information • each 15 mL contains: sodium 7 mg • store at 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 17 words ▾

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

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

📄 Do Not Use 98 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

📄 Ask a Doctor Before Use If 54 words ▾

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, or emphysema

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

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

📄 When Using This Product 10 words ▾

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 73 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 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 10 words ▾

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

📄 Keep Out of Reach of Children 46 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.

📄 Questions or Comments 2 words ▾

Questions? 1-800-719-9260

📄 Package Label / Principal Display Panel 58 words ▾

Principal Display Panel CAREone ® Compare to the active ingredients in Vicks ® DayQuil ® Cold & Flu DAYTIME COLD & FLU Pain Reliever/Fever Reducer-Acetaminophen Cough Suppressant-Dextromethorphan HBr Nasal Decongestant-Phenylephrine HCl Powerful Non-Drowsy Relief Alcohol Free Relieves: Aches, Fever, Sore Throat Nasal Congestion Cough See New Warnings OUR PHARMACISTS RECOMMEND Original Flavor 12 FL OZ (355 mL) 656-of-daytime-cold-and-flu

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

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 ✓ 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 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 American Sales Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 237 ml (41520-0032-34). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
American Sales Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 41520-0031-36 · American 41520-0033-64 · American →
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.