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Aspirin Low Dose 81 mg Tablet, 300-count — NDC 84324-0017-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aspirin Low Dose 81 mg Tablet, 300-count — NDC 84324-017-01 (Billing 84324-0017-01)

by NUVICARE LLC · 300 TABLET in 1 BOTTLE

This is a package of 300 tablets of Aspirin Low Dose 81 mg Tablet from NUVICARE LLC, marketed since Aug 2024 and currently FDA-listed. It is this product's only package size.

NDC 84324-0017-01
🏷️ FDA NDC (as labeled) 84324-017-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 84324-017-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84324 labeler · 017 product · 01 package
Package marketed since
Aug 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0384324000039
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84324-017-01
Product NDC 84324-017
11-digit billing NDC 84324001701
RxCUI 243670
UNII R16CO5Y76E
UPC 0384324000039
Application # M013
SPL Set ID 3a4aa3c7-b726-4303-8803-74196fa5637a
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-01
Route ORAL
Dosage form TABLET
Substance ASPIRIN
Quick answers
  • RxCUI (RxNorm): 243670
Why two NDCs? The FDA registers this code as 84324-017-01 — 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 → 84324-0017-01. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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

📗 Our plain-language guide HelloPharmacist
  • Aspirin is used to temporarily relieve common minor pains — things like headaches, backaches, muscle aches, toothaches, menstrual cramps, and discomfort from a cold — and to reduce...
  • Generally, no — aspirin should not be given to children under 12. More importantly, children and teenagers who have or are recovering from chickenpox or a flu-like illness should n...
  • Yes, stomach upset, heartburn, and nausea are real possibilities with aspirin. Taking it with a full glass of water helps. Some people tolerate enteric-coated or delayed-release fo...
  • Does aspirin upset your stomach? What can I do about it?
📖 Read our full Aspirin guide →
3
Nutrient depletion considerations

Aspirin may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aspirin 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 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
84324-0017-01 You're viewing this Main listing 300 TABLET in 1 BOTTLE 2024-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Low Dose Aspirin 81 mg 70677-1150-01 Strategic 120 tablets $0.014 — Availability likely —
Aspirin Low Dose 81 mg 00904-6783-70 MAJOR 250 tablets $0.014 — Availability likely —
Aspirin 81 81 mg 57237-0302-10 Rising 1000 tablets $0.014 — Availability likely —
Low Dose Aspirin 81 mg 46122-0761-58 AmerisourceBergen 120 tablets $0.014 — Availability likely —
Low dose aspirin 81mg 81 mg 21130-0481-12 BETTER 120 tablets — — FDA listed —
Aspirin Low Dose 81 mgthis 84324-0017-01 NUVICARE 300 tablets — — FDA listed —
Aspirin 81 mg 17714-0121-06 Advance 240 tablets — — FDA listed —
aspirin low dose enteric coated 81 mg 49483-0387-00 Time-Cap 100000 tablets — — FDA listed —
aspirin low dose enteric coated 81 mg 49483-0390-00 Time-Cap 100000 tablets — — FDA listed —
Aspirin 81 mg 54738-0559-03 Richmond 1000 tablets — — FDA listed —
Dye-Free Aspirin 81 81 mg 00363-6455-12 WALGREENS 14400 tablets — — FDA listed —
Low Dose Aspirin 81 mg 49483-0481-00 TIME 1000000 tablets — — FDA listed —
Enteric Coated Aspirin 81 mg 54257-0274-06 Magno-Humphries, 1000 tablets — — FDA listed —
Aspirin 81mg Enteric coated Delayed Release 81 mg 69168-0405-40 Allegiant 40 tablets — — FDA listed —
Aspirin 81mg Enteric coated Delayed Release 81 mg 72714-0405-17 Dr. 300 tablets — — FDA listed —
Aspirin Enteric Safety Coated 81 mg 56062-0063-12 Publix 120 tablets — — FDA listed —
Adult Low Dose Enteric Coated Aspirin 81 mg 68788-8606-01 Preferred 100 tablets — — FDA listed —
Aspirin 81 mg 71335-1774-01 Bryant 120 tablets — — FDA listed —
Gencare-Aspirin Low Dose Pain reliever (NSAID) 81 mg 72090-0037-01 Pioneer 500 tablets — — FDA listed —
Low Dose Aspirin 81 mg 79903-0481-11 Walmart 250 tablets — — FDA listed —
Aspirin 81 mg 36800-0968-05 TOP 500 tablets — — FDA listed —
Low Dose Aspirin 81 mg 42507-0006-12 Hy-Vee 120 tablets — — FDA listed —
Aspirin Enteric Safety Coated 81 mg 56062-0867-12 Publix 120 tablets — — Discontinued —
Low Dose Aspirin 81 mg 59726-0065-30 P 300 tablets — — FDA listed —
Ecotrin 81 mg 63029-0311-01 Medtech 150 tablets — — FDA listed —
Low Dose Aspirin 81 mg 63629-8875-01 Bryant 1000 tablets — — FDA listed —
St. Joseph Low Dose Aspirin 81 mg 69536-0181-12 Foundation 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 71205-0112-10 Proficient 10 tablets — — FDA listed —
Low Dose Aspirin 81 mg 71399-1014-01 Akron 1000 tablets — — FDA listed —
Low Dose Aspirin 81 mg 71399-8627-01 Akron 1000 tablets — — Discontinued —
Low Dose Aspirin 81 mg 63629-8878-01 Bryant 30 tablets — — FDA listed —
Aspirin 81 mg 69618-0066-02 Reliable 120 tablets — — FDA listed —
RIGHT REMEDIES LOW DOSE Aspirin 81mg 81 mg 70692-0168-50 Strive 500 tablets — — FDA listed —
Aspirin 81 mg 81005-0103-10 Aarkish 1000 tablets — — FDA listed —
Low Dose Aspirin 81 mg 00615-8414-39 NCS 30 tablets — — FDA listed —
Low Dose Aspirin 81 mg 50090-4830-01 A-S 120 tablets — — FDA listed —
Adult Low Dose Enteric Coated Aspirin 81 mg 57896-0981-01 Geri-Care 100 tablets — — FDA listed —
Aspirin 81 81 mg 00363-6452-50 WALGREENS 500 tablets — — FDA listed —
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen 81 mg 69168-0430-99 Allegiant 365 tablets — — FDA listed —
Aspirin 81 mg 70677-1245-01 Strategic 180 tablets — — FDA listed —
Aspirin Low Dose 81 mg 71335-0622-01 Bryant 120 tablets — — FDA listed —
Aspirin Pain reliver 81 mg 72090-0001-01 Pioneer 500 tablets — — FDA listed —
Low Dose Aspirin 81 mg 72162-1470-03 Bryant 30 tablets — — FDA listed —
meijer LOW DOSE Aspirin 81 mg 79481-0168-01 Meijer, 120 tablets — — FDA listed —
Aspirin 81 mg 11673-0181-12 TARGET 120 tablets — — FDA listed —
Bayer Low Dose 81 mg 00280-2100-12 Bayer 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 68196-0481-70 SAM'S 365 tablets — — FDA listed —
Aspirin Low Dose Safety Coated 81 mg 72476-0263-12 Care 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 37808-0630-30 H 300 tablets — — FDA listed —
Adult Low Dose Enteric Coated Aspirin 81 mg 60760-0673-60 St. 60 tablets — — Discontinued —
Aspirin 81 mg 68788-4097-08 Preferred 120 tablets — — FDA listed —
CAREALL Aspirin 81 mg 51824-0077-01 New 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 71335-1382-01 Bryant 120 tablets — — FDA listed —
Aspirin Pain reliver 81 mg 72090-0034-01 Pioneer 500 tablets — — FDA listed —
Aspirin 81 mg 76420-0224-30 Asclemed 30 tablets — — FDA listed —
Adult Low Dose Enteric Coated Aspirin 81 mg 85766-0147-00 Sportpharm 1000 tablets — — FDA listed —
Aspirin 81 mg 55910-0765-12 Dolgencorp, 120 tablets — — FDA listed —
Adult Low Dose Enteric Coated Aspirin 81 mg 68071-3829-02 NuCare 120 tablets — — FDA listed —
Aspirin 81 mg 10135-0729-62 Marlex 120 tablets — — FDA listed —
Aspirin 81 mg 41226-0481-12 Kroger 120 tablets — — FDA listed —
Aspirin Low Dose Safety Coated 81 mg 68391-0063-50 BJWC 500 tablets — — FDA listed —
Low Dose Aspirin 81 mg 76162-0980-05 Topco 500 tablets — — FDA listed —
Aspirin 81 mg 85534-0042-00 HAWAII 30 tablets — — FDA listed —
Cardiaspirin Protect 81 mg 69729-0104-12 OPMX 120 tablets — — FDA listed —
Aspirin 81 mg 59726-0103-30 P 300 tablets — — 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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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.

🧪 Avoiding an ingredient? See Aspirin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesMicrocrystalline Cellulose, Lactose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Acrylcoat L 30 (Methacrylic Acid copolymer), Triethyl citrate, Polysorbate 80, Sodium hydroxide, Talc, Titanium Dioxide, D & C yellow # 10 Aluminum lake, yellow oxide of iron.

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

LabelerNUVICARE LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code84324
First marketedAug 2024
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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 50 words ▾

Uses: • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief • ask your doctor about other uses for Safety Coated 81 mg Aspirin

⏱️ Dosage and Administration 45 words ▾

DIRECTIONS drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

⚠️ Warnings 176 words ▾

Warnings: Reye's syndrome Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients

🧪 Active Ingredient 11 words ▾

Active Ingredient (in each tablet) Aspirin 81mg (NSAID)* *Nonsteroidal Anti-Inflammatory Drug

🧪 Inactive Ingredients 37 words ▾

INACTIVE INGREDIENTS Microcrystalline Cellulose, Lactose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Acrylcoat L 30 (Methacrylic Acid copolymer), Triethyl citrate, Polysorbate 80, Sodium hydroxide, Talc, Titanium Dioxide, D & C yellow # 10 Aluminum lake, yellow oxide of iron.

🎯 Purpose 3 words ▾

Purpose Pain reliever

📄 Ask a Doctor Before Use If 42 words ▾

Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma

📄 Ask a Doctor or Pharmacist Before Use If 21 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for • gout • diabetes • arthritis

📄 Stop Use and Ask a Doctor If 79 words ▾

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days Fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 22 words ▾

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 13 words ▾

OTHER INFORMATION • store at room temperature. Avoid excessive heat above 40°C (104°F).

📄 Questions or Comments 10 words ▾

QUESTIONS OR COMMENTS? Call 1 (718) 337-8733 or visit [email protected]

📄 Package Label / Principal Display Panel 4 words ▾

PL0222-00 NC-Aspirin 81mg 300ct

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
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.
← 84324-0016-01 · NUVICARE 84324-0018-01 · 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.