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Vicks NyQuil HOT REMEDY Cold and Flu Acetaminophen, Diphenhydramine HCl 650 mg; 25 mg Powder, For Solution, 1 powder — NDC 58933-0555-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vicks NyQuil HOT REMEDY Cold and Flu Acetaminophen, Diphenhydramine HCl 650 mg; 25 mg Powder, For Solution, 1 powder — NDC 58933-555-01 (Billing 58933-0555-01)

by Procter & Gamble Manufactura S de RL de CV · 1 POWDER, FOR SOLUTION in 1 PACKET

This is a package of 1 powder of Vicks NyQuil HOT REMEDY Cold and Flu Acetaminophen, Diphenhydramine HCl 650 mg; 25 mg Powder, For Solution from Procter & Gamble Manufactura S de RL de CV, marketed since Jun 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58933-0555-01
🏷️ FDA NDC (as labeled) 58933-555-01 billing pads the product segment with a zero
This package
Contains1 powder Pack sizes2 compare ↓
Main listing for product 58933-555 · Also comes in: 8 packets 58933-555-08
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 58933-555-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58933 labeler · 555 product · 01 package
Package marketed since
Jun 11, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0323900035188
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58933-555-01
Product NDC 58933-555
11-digit billing NDC 58933055501
RxCUI 2670677
UNII 362O9ITL9D, TC2D6JAD40
UPC 0323900035188
Application # M012
SPL Set ID 4535d4fe-9de7-f2c6-e063-6394a90a944a
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action 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 2025-06-11
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2670677
Why two NDCs? The FDA registers this code as 58933-555-01 — 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 → 58933-0555-01. 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 that dissolves in water and is taken by mouth. It contains acetaminophen, a pain reliever and fever reducer, combined with diphenhydramine hydrochloride, an antihistamine commonly used to relieve cold and allergy symptoms including sneezing and runny nose. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for over-the-counter cold and flu remedies. The powder formulation is designed to be mixed with liquid before use.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Acetaminophen, Diphenhydramine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Diphenhydramine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
58933-0555-01 You're viewing this Main listing 1 POWDER, FOR SOLUTION in 1 PACKET 2025-06-11 — Active
58933-0555-08 58933-555-08 8 PACKET in 1 PACKAGE / 1 POWDER, FOR SOLUTION in 1 PACKET 2025-06-11 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 powder — 1 powder, for solution in 1 packet.
How does this package differ from NDC 58933-0555-08?
Both are Vicks NyQuil HOT REMEDY Cold and Flu Acetaminophen, Diphenhydramine HCl 650 mg; 25 mg Powder, For Solution — the drug itself is identical. This page's package is the 1 powder one, while NDC 58933-0555-08 is the 8 packets package.
What NDC number is used to bill for this package of Vicks NyQuil HOT REMEDY Cold and Flu Acetaminophen, Diphenhydramine HCl 650 mg; 25 mg 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
Theraflu Severe Cold Relief Nighttime 650 mg/1; 25 mg 00067-0101-06 Haleon 6 packets — — FDA listed —
Theraflu Severe Cold Relief Nighttime 650 mg/1; 25 mg 50269-0101-06 JC 20 packets — — FDA listed —
Vicks NyQuil HOT REMEDY Cold and Flu 650 mg/1; 25 mgthis 58933-0555-01 Procter 1 powder — — FDA listed —
Chloraseptic Nighttime Sore Throat Hot Relief 650 mg/1; 25 mg 67172-0150-06 Prestige 6 powders — — FDA listed —
Equate Severe Cold Cough and Flu 650 mg/1; 25 mg 79903-0356-01 WALMART 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

🏛️
2025
On the market since
Jun 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.

What it looks like

Color white
FlavorHoney
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • 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 Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII 05JZI7B19X
    A plant-based thickener made from cellulose that holds water and creates texture. It works as a binder and thickening agent to give the medicine its proper consistency and help ingredients blend together.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.

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

The official label also statesacesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor,  sodium cirate, sucrose, tricalcium phosphate

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

LabelerProcter & Gamble Manufactura S de RL de CV
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58933
First marketedJun 2025
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 ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 📦 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: minor aches & pains sore throat fever headache cough due to minor sore throat & bronchial irritation cough to help you sleep 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 25 words ▾

Other information • each packet contains: potassium 10 mg • phenylketonurics: contains phenylalanine 68 mg per dose • store at no greater than 25°C (77°F)

🧪 Active Ingredient 19 words ▾

Active Ingredient (in each Packet) Acetaminophen 650 mg Diphenhydramine HCl 25 mg Purpose Pain reliever/fever reducer Antihistamine, Cough suppressant

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavor, sodium cirate, sucrose, tricalcium phosphate

🎯 Purpose 7 words ▾

Purpose Pain reliever/fever reducer Antihistamine, Cough suppressant

📄 Do Not Use 90 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 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 44 words ▾

Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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 sedatives or tranquilizers taking the blood thinning drug warfarin

📄 When Using This Product 34 words ▾

When using this product 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 54 words ▾

Stop use and ask a doctor if pain 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 39 words ▾

PRINCIPAL DISPLAY PANEL - 8 packet package NEW FORMULA Vicks® NyQuil™ HOT REMEDY COLD & FLU Acetaminophen, Diphenhydramine HCl Headache, Fever, Sore Throat, Minor Aches & Pains Cough, Sneezing, Runny Nose HONEY LEMON FLAVORED Nighttime Relief 8 PACKETS 553

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 Vicks NyQuil HOT REMEDY Cold and Flu (this brand).

Top reported reactions

Asthenia1
Asthma1
Cough1
Disorientation1
Drug Toxicity1
Dysstasia1
Facial Paralysis1

Reporter sex

3 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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 Procter & Gamble Manufactura S de RL de CV. 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 8 packets (58933-0555-08). 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.
← 58933-0554-06 · Procter 58933-0556-06 · Procter →
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.