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Vicks DayQuil NyQuil HOT REMEDY Cold and Flu Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl Kit — NDC 58933-554-16 (Billing 58933-0554-16)

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

This is a package of Vicks DayQuil NyQuil HOT REMEDY Cold and Flu Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl Kit from Procter & Gamble Manufactura S de RL de CV, no longer marketed (first marketed Jun 2025), no longer in the FDA NDC Directory.

NDC 58933-0554-16
🏷️ FDA NDC (as labeled) 58933-554-16 billing pads the product segment with a zero
This package
Contains1 kit in 1 package * 5 g in 1 packet * 5 g in 1 packet Pack sizes2 compare ↓
Product page 58933-0554-06 Also comes in: 1 kit 58933-554-06
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 58933-554-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58933 labeler · 554 product · 16 package
Package marketed since
Jun 11, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5893355416 0
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58933-554-16
Product NDC 58933-554
11-digit billing NDC 58933055416
RxCUI 2670598, 2679420, 2679425, 2679426
Application # M012
SPL Set ID 42b74523-1389-c7ff-e063-6394a90a2f5f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2025)
Marketing start 2025-06-11
Route ORAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 2670598
Why two NDCs? The FDA registers this code as 58933-554-16 — 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 → 58933-0554-16. 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?

This is an over-the-counter oral kit containing acetaminophen, dextromethorphan hydrobromide, and diphenhydramine hydrochloride. Acetaminophen is typically used to reduce fever and relieve pain. Dextromethorphan is commonly used to suppress cough, while diphenhydramine functions as an antihistamine and can cause drowsiness. This combination product is labeled for cold and flu symptom relief and is marketed under FDA's OTC monograph rules for such products.

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 eachPer 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: 1 kit
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
58933-0554-06 58933-554-06 Main listing 1 KIT in 1 PACKAGE * 5 g in 1 PACKET * 5 g in 1 PACKET 2025-06-11 — Discontinued by firm
58933-0554-16 You're viewing this 1 KIT in 1 PACKAGE * 5 g in 1 PACKET * 5 g in 1 PACKET 2025-06-11 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 package * 5 g in 1 packet * 5 g in 1 packet.
What NDC number is used to bill for this package of Vicks DayQuil NyQuil HOT REMEDY Cold and Flu Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl Kit?
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
Vicks DayQuil NyQuil HOT REMEDY Cold and Flu 58933-0556-06 Procter 1 kit — — FDA listed —
Vicks DayQuil NyQuil HOT REMEDY Cold and Fluthis 58933-0554-16 Procter 1 kit — — Discontinued —
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.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 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 📦 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 53 words ▾

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

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 164 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

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 2 words ▾

Warnings

Warnings

📦 Storage and Handling 45 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)

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 24 words ▾

Active Ingredient (in each Packet) Acetaminophen 500 mg Dextromethorphan HBr 20 mg

Active Ingredient (in each Packet) Acetaminophen 650 mg Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 52 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 citrate, sucrose, tricalcium phosphate

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 citrate, sucrose, tricalcium phosphate

🎯 Purpose 18 words ▾

Purpose Headache, Fever, Sore Throat, Minor Aches & Pains Cough

Purpose Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

📄 Do Not Use 171 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.

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 74 words ▾

Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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 36 words ▾

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

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 108 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.

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 20 words ▾

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

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

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children.

Keep out of reach of children.

📄 Questions or Comments 4 words ▾

Questions? 1-800-362-1683

Questions? 1-800-362-1683

📄 Package Label / Principal Display Panel 70 words ▾

PRINCIPAL DISPLAY PANEL - 6 packet package NEW FORMULAS VALUE PACK Vicks ® DayQuil™ HOT REMEDY COLD & FLU Acetaminophen, Dextromethorphan HBr Headache, Fever, Sore Throat, Minor Aches & Pains Cough Non-Drowsy Vicks ® NyQuil™ HOT REMEDY COLD & FLU Acetaminophen, Diphenhydramine HCl Headache, Fever, Sore Throat, Minor Aches & Pains Cough, Sneezing, Runny Nose Nighttime Relief HONEY LEMON FLAVORED 3 DAYQUIL PACKETS; 3 NYQUIL PACKETS; 6 TOTAL PACKETS 554

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 HBr, Diphenhydramine HCl — the ingredient across all brands.

Top reported reactions

Dyspnoea8
Fatigue8
Pain8
Nasopharyngitis7
Anxiety6
Feeling Abnormal6
Headache6

Age at onset

Adult5
Elderly2

Reporter sex

81 reports
Male · 23%
Female · 72%
Unknown · 5%

Serious outcomes

Hospitalization22
Life-threatening6
Death4
Disabling2
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 7 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 Kit / multi-component package No longer marketed (per FDA listing data)

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (58933-0554-06). 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.
← 58933-0552-01 · Procter 58933-0555-01 · 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.