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Nuvicare DayTime and NightTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate Kit — NDC 84324-0025-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nuvicare DayTime and NightTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate Kit — NDC 84324-025-01 (Billing 84324-0025-01)

by NUVICARE LLC · 1 KIT in 1 CARTON * 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of Nuvicare DayTime and NightTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate Kit from NUVICARE LLC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 84324-0025-01
🏷️ FDA NDC (as labeled) 84324-025-01 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 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 84324-025-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84324 labeler · 025 product · 01 package
Package marketed since
Jun 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0384324000176
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84324-025-01
Product NDC 84324-025
11-digit billing NDC 84324002501
RxCUI 1086997, 1094549, 2634564
UPC 0384324000176
Application # M012
SPL Set ID f5764925-c586-40e4-8252-24d92389af01
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-09
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1086997
Why two NDCs? The FDA registers this code as 84324-025-01 — 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 → 84324-0025-01. 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

📖 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?

Nuvicare DayTime and NightTime Cold and Flu is an over-the-counter combination kit containing two formulations. The daytime product typically contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a nasal decongestant). The nighttime product adds doxylamine succinate, an antihistamine commonly used to promote drowsiness. Together, these products are designed to address multiple cold and flu symptoms, with the nighttime formula intended for use when sleep is desired.

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.
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
84324-0025-01 You're viewing this Main listing 1 KIT in 1 CARTON * 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2025-06-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels 00280-0125-01 Bayer 6 capsules — — FDA listed —
Kroger DayTime and NightTime Cold and Flu SOFTGEL 59450-0048-48 The 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels 00280-8288-16 Bayer 1 capsule — — FDA listed —
Nuvicare DayTime and NightTime Cold and Flu 84324-0020-01 NUVICARE 6 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels 00280-1650-16 Bayer 6 capsules — — FDA listed —
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels 00280-8283-24 Bayer 1 capsule — — FDA listed —
Nuvicare DayTime and NightTime Cold and Fluthis 84324-0025-01 NUVICARE 6 capsules — — FDA listed —
Kroger Daytime and Nighttime Cold and Flu Softgel 30142-0233-74 The 8 capsules — — 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 red / green
Shapecapsule
ImprintNL01
Size21 mm
ScoringNot scored
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.

From the label’s inactive-ingredient section(Daytime)-  Polyethylene glycol-400, Propylene glycol, Povidone K-30, Purified water, Gelatin, Glycerol, Sorbitol sorbitan solution,FD&C Red No. 40, FD&C Yellow No. 6. (Nighttime)-  Polyethylene glycol-400, Propylene glycol, Povidone K-30, Purified water, Gelatin, Glycerin, Sorbitol sorbitan solution,D&C Yellow No. 10, FD&C Blue No. 1.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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

LabelerNUVICARE LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code84324
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio43 products on file

More NDCs from NUVICARE LLC labeler code 84324

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 39 words ▾

Uses: temporarily relieves common cold/flu symptoms: ■ nasal congestion (DayTime Only) ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches & pains ■ fever ■ Runny nose and sneezing (NightTime only)

⏱️ Dosage and Administration 75 words ▾

Directions ■ take only as directed- see OVERDOSE WARNING ■ do not exceed 8 softgels per 24 hrs. ■ Take softgels with water DayTime NightTime Adults and children age 12 yrs and over 2 softgels every 4 hrs. 2 softgels every 6 hrs. Children 4 to under 12 yrs ask a doctor ask a doctor Children under 4 yrs do not use do not use Read each label carefully before taking Daytime and Nighttime products.

⚠️ Warnings 109 words ▾

Warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 doses in 24 hrs, 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: acetamenophen may cause severe skin recations.

Symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin reactions 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 41 words ▾

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms. # 1 (800) 222-1222

📦 Storage and Handling 15 words ▾

Other information ■ store between 15-30°C (59-86 °F) ■ avoid excessive heat, cold and humidity

🧪 Active Ingredient 33 words ▾

Active ingredients Active ingredients in DayTime (in each softgel) Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg Active ingredients in NightTime (in each softgel) Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine Succinate 6.25 mg

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients (Daytime)- Polyethylene glycol-400, Propylene glycol, Povidone K-30, Purified water, Gelatin, Glycerol, Sorbitol sorbitan solution,FD&C Red No. 40, FD&C Yellow No. 6. (Nighttime)- Polyethylene glycol-400, Propylene glycol, Povidone K-30, Purified water, Gelatin, Glycerin, Sorbitol sorbitan solution,D&C Yellow No. 10, FD&C Blue No. 1.

🎯 Purpose 33 words ▾

Purpose DayTime Acetaminophen 325mg.....................Pain reliever/fever reducer Dextromethorphan HBr 10mg..................... Cough suppressant Phenylephrine HCl 5mg ............................. Nasal decongestant NightTime Acetaminophen 325mg.....................Pain reliever/fever reducer Dextromethorphan HBr 15mg..................... Cough suppressant Doxylamine succinate 6.25 mg ............................. Antihistamine

📄 Do Not Use 86 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. to make a child sleep (NightTime Only).

📄 Ask a Doctor Before Use If 70 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

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

📄 When Using This Product 45 words ▾

When using this product- do not use more than directed. In addition when using NightTime: excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machiner alcohol, sedative and tranquilizers may increase drowsiness

📄 Stop Use and Ask a Doctor If 67 words ▾

Stop use and ask a doctor if you get nervous, dizzy or sleepless (DayTime Only) pain, cough or nasal congestion (DayTime only) may get worse or last 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 11 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 10 words ▾

Questions or Comments? Call 1 (718) 337-8733 or email: [email protected]

📄 Package Label / Principal Display Panel 5 words ▾

PP0145-00 NC(nosymbol)-Daytime+Nighttime Cold+Flu Soft Gels-10ct_page-0001

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

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 ✓ 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 NUVICARE LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NUVICARE 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.
← 84324-0024-01 · NUVICARE 84324-0026-01 · NUVICARE →
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.