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Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 10 mg/5g; 650 mg/5g; 25 mg/5g Powder, For Solution, 5 g — NDC 58933-551-01 (Billing 58933-0551-01)

by Procter & Gamble Manufactura S de RL de CV · 5 g in 1 PACKET

This is a package of 5 g of Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 10 mg/5g; 650 mg/5g; 25 mg/5g Powder, For Solution from Procter & Gamble Manufactura S de RL de CV, marketed since Mar 2023 and currently FDA-listed, this package's marketing is listed to end Jun 2027. It is the main listing for this product, which comes in 2 package sizes.

NDC 58933-0551-01
🏷️ FDA NDC (as labeled) 58933-551-01 billing pads the product segment with a zero
This package
Contains5 g Pack sizes2 compare ↓
Main listing for product 58933-551 · Also comes in: 8 packets 58933-551-08
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 →

NDC database record

One package, one record: these facts belong to NDC 58933-551-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58933 labeler · 551 product · 01 package
Package marketed since
Mar 22, 2023
Package marketing ended
Jun 30, 2027
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 5893355101 5
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58933-551-01
Product NDC 58933-551
11-digit billing NDC 58933055101
RxCUI 1659960
UNII 04JA59TNSJ, 362O9ITL9D, TC2D6JAD40
Application # M012
SPL Set ID f771aa19-295a-9f4e-e053-6294a90a1674
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-22
Marketing end 2027-06-30
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1659960
Why two NDCs? The FDA registers this code as 58933-551-01 — 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 → 58933-0551-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

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

Clinical

🧪 What is this product?

Vicks NyQuil HOT REMEDY is an over-the-counter powder product meant to be mixed with water and taken by mouth. It contains acetaminophen, which is typically used to reduce fever and relieve pain, along with diphenhydramine, an antihistamine commonly used to reduce sneezing, runny nose, and other cold and allergy symptoms. The product also contains phenylephrine, a decongestant typically used to help relieve nasal congestion. This combination product is marketed as an OTC monograph drug for cold and flu symptom relief.

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: 8 packets
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
58933-0551-01 You're viewing this Main listing 5 g in 1 PACKET 2023-03-22 Jun 30, 2027 Active
58933-0551-08 58933-551-08 8 PACKET in 1 PACKAGE / 5 g in 1 PACKET 2023-03-22 Jun 30, 2027 Active

Pack size FAQ

What quantity is in this package?
This package contains 5 g — 5 g in 1 packet.
What NDC number is used to bill for this package of Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 10 mg/5g; 650 mg/5g; 25 mg/5g Powder, For 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
Quality Choice Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mg 63868-0291-06 Chain 6 packets $0.482 — FDA listed —
Theraflu Powerpods Nighttime Severe Cold 650 mg/1; 25 mg/1; 10 mg 00067-6095-01 Haleon 8 pouches — — FDA listed —
Theraflu Severe Cold Relief Nighttime 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-6803-02 Haleon 6 packets — — FDA listed —
Theraflu Nighttime Severe Cold And Cough 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-7918-06 Haleon 6 packets — — FDA listed —
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor 650 mg/1; 25 mg/1; 10 mg 00067-8212-01 Haleon 6 packets — — FDA listed —
Nighttime Wal Flu Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 00363-5410-06 WALGREEN 6 powders — — FDA listed —
up and up nighttime flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 11673-0113-07 Target 6 powders — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 41226-0541-06 KROGER 6 powders — — FDA listed —
Equate Flu and Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 49035-0964-91 Wal-Mart 6 powders — — FDA listed —
SanaTos Severe Cold Relief Nighttime 25 mg/1; 10 mg/1; 650 mg 55758-0385-06 Pharmadel 6 granules — — FDA listed —
dg health flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 55910-0964-91 Dolgencorp, 6 powders — — FDA listed —
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 10 mg/5g; 650 mg/5g; 25 mg/5gthis 58933-0551-01 Procter 5 g — — FDA listed —
Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mg 67091-0323-06 WinCo 6 packets — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 68163-0541-06 RARITAN 6 packets — — FDA listed —
Basic Care severe cold and cough 650 mg/1; 25 mg/1; 10 mg 72288-0964-91 Amazon.com 6 packets — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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

LabelerProcter & Gamble Manufactura S de RL de CV
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58933
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from Procter & Gamble Manufactura S de RL de CV labeler code 58933

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 53 words ▾

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

⏱️ Dosage and Administration 86 words ▾

Directions • take only as directed • do not exceed 6 doses per 24 hrs • Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes • If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat Age Dose Adults & children 12 yrs & over one packet (dose) every 4 hours Children under 12 yrs Do not use

⚠️ Warnings 104 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

🆘 Overdosage 37 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away. 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 22 words ▾

Other information • each packet contains: potassium 10 mg • phenylketonurics: contains phenylalanine 68 mg per dose • do not exceed 25°C.

🧪 Active Ingredient 25 words ▾

Active Ingredient (in each Packet) Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg Purpose Pain reliever/fever reducer Antihistamine, Cough Suppressant Nasal decongestant

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

🎯 Purpose 9 words ▾

Purpose Pain reliever/fever reducer Antihistamine, Cough Suppressant Nasal decongestant

📄 Do Not Use 91 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. with any other product containing diphenhydramine, even one used on the skin. 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 50 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

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

📄 When Using This Product 40 words ▾

When using this product Do not use more than directed excitability may occur especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 62 words ▾

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 2 words ▾

Questions? 1-800-362-1683

📄 Package Label / Principal Display Panel 51 words ▾

PRINCIPAL DISPLAY PANEL - 8 packet package MAX STRENGTH Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU + CONGESTION Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Headache, Fever, Sore Throat, Minor Aches & Pains Sneezing, Runny Nose, Cough Nasal Congestion, Sinus Pressure Nighttime Relief HONEY LEMON FLAVORED 8 POWDER PACKETS 551

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, Diphenhydramine HCl, Phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Fatigue56
Nausea45
Dyspnoea44
Headache39
Diarrhoea36
Pain33
Cough30

Age at onset

Child1
Adolescent2
Adult40
Elderly31

Reporter sex

563 reports
Male · 28%
Female · 71%
Unknown · 1%

Serious outcomes

Hospitalization124
Death30
Life-threatening12
Disabling12
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 60 20
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 it is currently marketed — but Procter & Gamble Manufactura S de RL de CV has reported a marketing end date of 2027-06-30, after which this package is expected to stop being marketed. 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 8 packets (58933-0551-08). 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?
Procter & Gamble Manufactura S de RL de CV 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.
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.