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DAY-TIME Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Liquid, 354 mL

by DeMoulas Market Basket · 354 mL in 1 BOTTLE (53942-506-28)
NDC 53942-0506-28
🏷️ FDA NDC (as labeled) 53942-506-28 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 53942-506-28
Product NDC 53942-506
11-digit billing NDC 53942050628
RxCUI 1113705
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Application # M013
SPL Set ID ce900e42-d0c8-408d-a1c3-3a9bef1c97ee
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 2012-09-12
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 53942-506-28 — 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 → 53942-0506-28. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

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

🏭 Manufacturer & labeler

LabelerDeMoulas Market Basket
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code53942
First marketedSep 2012
Product typeHuman Otc Drug
Portfolio19 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter oral liquid cold and flu product containing three active ingredients. Acetaminophen is typically used to reduce fever and relieve aches and pain. Dextromethorphan is commonly used as a cough suppressant. Phenylephrine hydrochloride functions as a nasal decongestant to help relieve congestion. This product is marketed under the FDA's over-the-counter drug monograph rules for multi-ingredient cold and flu remedies.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also statescitric acid, FD and C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose

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.

💲 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.

🔁 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/15mL 41520-0032-34 American 237 ml — — Discontinued —
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/15mLthis 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 —
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

🏛️
2012
On the market since
Sep 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Choking25
Foreign Body In Respiratory Tract10
Foreign Body In Throat8
Fatigue7
Covid-196
Anxiety5
Insomnia5

Age at onset

Adult18
Elderly8

Reporter sex

93 reports
Male · 30%
Female · 70%

Serious outcomes

Hospitalization11
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 10 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53942-0506-28 You're viewing this 354 mL in 1 BOTTLE (53942-506-28) 2012-09-12 Active

🧭 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) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 53942-506-28, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53942-0506-28, written without dashes as 53942050628. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53942-0506-28, the first segment (53942) is the labeler code FDA assigned to DeMoulas Market Basket; the middle segment (0506) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (28) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DeMoulas Market Basket. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DeMoulas Market Basket is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 words ▾

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

⏱️ Dosage and Administration 86 words ▾

Directions Directions take only as recommended (see overdose warning) use dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours age dose adults and children 12 years and over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

⚠️ Warnings 99 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy Alert: Acetaminophen may causesevere skin reactions.

Symptoms may include: skin reddening blisters rash If a skin reactions occurs, stop 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.

🆘 Overdosage 54 words ▾

Overdose Warning Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 21 words ▾

Drug Facts Active Ingredients (in each 15 mL, 1 tablespoon) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCL 5 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients citric acid, FD and C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53942-0505-24 · DeMoulas 53942-0515-25 · DeMoulas →
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.