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REVASOL DAYTIME COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 10 mg/30mL; 20 mg/30mL; 650 mg/30mL Liquid, 118 mL — NDC 84379-0275-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

REVASOL DAYTIME COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 10 mg/30mL; 20 mg/30mL; 650 mg/30mL Liquid, 118 mL — NDC 84379-275-04 (Billing 84379-0275-04)

by Rnv LLC · 118 mL in 1 BOTTLE

This is a package of 118 mL of REVASOL DAYTIME COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 10 mg/30mL; 20 mg/30mL; 650 mg/30mL Liquid from Rnv LLC, marketed since Feb 2025 and currently FDA-listed. It is this product's only package size.

NDC 84379-0275-04
🏷️ FDA NDC (as labeled) 84379-275-04 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 Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 84379-275-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84379 labeler · 275 product · 04 package
Package marketed since
Feb 3, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8437927504 8
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84379-275-04
Product NDC 84379-275
11-digit billing NDC 84379027504
RxCUI 1113705
UNII 04JA59TNSJ, 9D2RTI9KYH, 362O9ITL9D
Application # M012
SPL Set ID 2f9ddcc3-b913-f8b0-e063-6294a90a93ab
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 2025-02-03
Route ORAL
Dosage form LIQUID
Substance PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 1113705
Why two NDCs? The FDA registers this code as 84379-275-04 — 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 → 84379-0275-04. 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?

Revasol Daytime Cold and Flu is an over-the-counter liquid taken by mouth that contains three active ingredients. Acetaminophen is typically used to reduce fever and relieve pain. Dextromethorphan is commonly used to suppress cough. Phenylephrine works as a decongestant to help relieve nasal congestion. This product is marketed under FDA's OTC monograph rules for cold and flu symptom relief.

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
84379-0275-04 You're viewing this Main listing 118 mL in 1 BOTTLE 2025-02-03 — Active

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/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/30mLthis 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

💡 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 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 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 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 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.

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

The official label also statesInactive ingredients citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, 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

LabelerRnv LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code84379
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio12 products on file

More NDCs from Rnv LLC labeler code 84379

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 🆘 Overdosage 🧪 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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Uses • temporarily relieves 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 71 words ▾

Directions • take only as directed (see overdose warning) • measure only with dosing cup provided and keep dosage cup with product • mL=mililiter • do not exceed 4 doses per 24 hours Age Dose adults and children 12 years of and over 30 mL every 4 hours children under 12 years do not use when using Day Time and Night Time products, carefully read each label to ensure correct dosing.

⚠️ Warnings 123 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: • adults and children over 12 years of age take more than 4 doses (30 mL each in 24 hours, which is the maximum daily amount for this product • 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, lasts 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 23 words ▾

Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650mg....................................................Pain reliever-Fever reducer Dextromethorphan HBr 20 mg.........................................Cough suppressant Phenylephrine HCl 10 mg................................................Nasal decongestant

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

🎯 Purpose 7 words ▾

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 56 words ▾

Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland • a cough that occurs with too much phlegm (mucus) or a 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 18 words ▾

When using this product • do not use more than directed (see overdose warning) • avoid alcoholic drinks.

📄 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 get 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.

📄 Keep Out of Reach of Children 17 words ▾

Keep out of the reach of children. If pregnant or breast-feeding, ask a health professional before use.

📄 Other Information 37 words ▾

Other information • Each 30 mL dose cup contains: sodium 10 mg • store at room temperature 15-30°C (59-86°F) and do not refrigerate TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

📄 Questions or Comments 13 words ▾

Questions or comments 1-888-446-4753 Monday - Friday (9 AM - 5 PM EST)

📄 Package Label / Principal Display Panel 4 words ▾

Revasol Cold Daytime. 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 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

Serious outcomes

Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 27 3
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 ✓ 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 Rnv LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rnv LLC 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.
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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.