NDC 84324-0037-01 — Nuvicare Long-Acting Cough Relief

🆔 Identity & classification

FDA NDC (as labeled) 84324-037-01

Product NDC 84324-037

11-digit billing NDC 84324003701

RxCUI 1090487

UNII 9D2RTI9KYH

Application # M012

SPL Set ID ec1d3dd6-2a8b-4487-81a2-be6313e97610

Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Mechanism of action 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 2026-03-24

Route ORAL

Dosage form CAPSULE, LIQUID FILLED

Substance DEXTROMETHORPHAN HYDROBROMIDE

Why two NDCs? The FDA registers this code as 84324-037-01 — 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 → 84324-0037-01. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist

Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives

How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists

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.

🏭 Manufacturer & labeler

LabelerNUVICARE LLC

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code84324

First marketedMar 2026

Product typeHuman Otc Drug

Portfolio43 products on file

🔎 All NDCs from NUVICARE LLC

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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

It won't necessarily silence your cough entirely, but it does temporarily suppress the cough reflex and reduce how intense and frequent your cough is. It can also help reduce that...
What exactly does dextromethorphan do — will it stop my cough completely?
It depends on your child's age and the specific product. Most dextromethorphan products should not be given to children under 4 years old without a doctor's guidance. Some products...
This is a really important question. If your antidepressant is an MAOI (monoamine oxidase inhibitor), you absolutely cannot take dextromethorphan — not while you're on it, and not...

📖 Read our full Dextromethorphan guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

💲 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 system	Per mL	Per 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dextromethorphan HBr 15 mg Liquid Gels 00536-1334-34	RUGBY	20 capsules	$0.117	—	Availability likely	—
QUALITY CHOICE Long Acting Cough Softgel 15 mg 83324-0303-20	Chain	20 capsules	$0.117	—	Availability likely	—
Robitussin Long-Acting Coughgels 15 mg 00031-8743-20	Haleon	20 capsules	—	—	FDA listed	—
Robitussin Direct Cough 15 mg 00031-9302-01	Haleon	18 capsules	—	—	FDA listed	—
Cough Relief 15 mg 00363-8990-20	WALGREEN	20 capsules	—	—	FDA listed	—
Cough Suppressant Adult 15 mg 00536-1480-34	Rugby	20 capsules	—	—	FDA listed	—
Dextromethorphan Hydrobromide 15 mg 35916-0461-01	Softgel	20 capsules	—	—	FDA listed	—
Long Acting Cough Softgels 15 mg 51316-0778-23	CVS	20 capsules	—	—	FDA listed	—
CVS Health COUGH SUPPRESSANT SOFTGEL 15 mg 51316-0877-23	CVS	20 capsules	—	—	FDA listed	—
Dextromethorphan HBr 15 mg 53345-0011-01	Humanwell	12000 capsules	—	—	FDA listed	—
Dextromethorphan HBr 15 mg 53345-0028-01	Humanwell	12000 capsules	—	—	FDA listed	—
Right Remedies Adult Long Lasting Cough Relief Softgel 15 mg 70692-0778-06	Strive	60 capsules	—	—	FDA listed	—
Gencare Long-Acting Cough Relief 15 mg 72090-0063-01	PIONEER	120 capsules	—	—	FDA listed	—
Dextromethorphan Hbr 15 Mg 73629-0005-10	AMZ789	100 capsules	—	—	FDA listed	—
Cough Relief 15 mg 80513-0311-06	Advanced	60 capsules	—	—	FDA listed	—
ValuMeds Cough Relief, Dextromethorphan Hbr 15 mg 82725-1010-01	Cabinet	120 capsules	—	—	FDA listed	—
Goodmeds Non-Drowsy Cough Relief 15 mg 82725-4010-01	Cabinet	120 capsules	—	—	FDA listed	—
Goodmeds Cough Relief Dextromethorphan HBr 15 mg 82725-4110-01	Cabinet	120 capsules	—	—	FDA listed	—
Adult Long Lasting Cough Relief 15 mg 83059-0027-01	Shield	15 capsules	—	—	Discontinued	—
Adult Long Lasting Cough Relief 15 mg 83059-0110-08	Shield	15 capsules	—	—	Discontinued	—
Nuvicare Long-Acting Cough Relief 15 mgthis 84324-0037-01	NUVICARE	60 capsules	—	—	FDA listed	—
QUALITY CHOICE Adult Long-Acting Cough Softgel 15 mg 83324-0346-20	Chain	20 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

🏛️

2026

On the market since

Mar 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

·

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.

🔬 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 Nuvicare Long-Acting Cough Relief (this brand).

Top reported reactions

Drug Abuse269

Toxicity To Various Agents237

Completed Suicide179

Diarrhoea140

Pyrexia134

Dyspnoea123

Nausea112

Reporter sex

Serious outcomes

Hospitalization1,023

Death984

Life-threatening262

Disabling121

Reports over time (by year) — tap or hover for the count & year

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
84324-0037-01 You're viewing this	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-037-01)	2026-03-24	Active

🧭 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 FDA registers it as 84324-037-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84324-0037-01, written without dashes as 84324003701. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 84324-0037-01, the first segment (84324) is the labeler code FDA assigned to NUVICARE LLC; the middle segment (0037) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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.

📄 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

🎯 Indications and Usage 17 words ▾

Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

⏱️ Dosage and Administration 53 words ▾

Directions do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use

⚠️ Warnings 56 words ▾

Warnings Do not use 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.

📦 Storage and Handling 15 words ▾

Other Informations store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light

🧪 Active Ingredient 11 words ▾

Active ingredient (in each liquid-filled capsule) Dextromethorphan HBr, USP 15 mg

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients Polyethylene glycol 400, propylene glycol, pvp k30, propyl gallate, purified water, gelatin, glycerin, sorbitol sorbitan solution, FD& C Blue no. 1, FD &C Red no 40, propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol, titanium dioxide, tween 80

🎯 Purpose 3 words ▾

Purpose Cough suppressant

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

🔗 Related NDC lookups

🧪 All Dextromethorphan Hydrobromide NDCsSame ingredient 🏭 All NUVICARE labeler NDCsLabeler code 84324 📚 All Sigma-1 Agonist NDCsDrug class

Nuvicare Long-Acting Cough Relief Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled, 60-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups