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Tension Headache Relief ACETAMINOPHEN, CAFFEINE 500 mg; 65 mg Tablet, 100-count — NDC 84324-0002-01 package photo

Tension Headache Relief ACETAMINOPHEN, CAFFEINE 500 mg; 65 mg Tablet, 100-count

by NUVICARE LLC · 100 TABLET in 1 BOTTLE (84324-002-01)
NDC 84324-0002-01
🏷️ FDA NDC (as labeled) 84324-002-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 84324-002-01
Product NDC 84324-002
11-digit billing NDC 84324000201
RxCUI 307686
UNII 362O9ITL9D, 3G6A5W338E
UPC 0384324000152
Application # M013
SPL Set ID ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-30
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CAFFEINE
Why two NDCs? The FDA registers this code as 84324-002-01 — 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 → 84324-0002-01. 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.

🏭 Manufacturer & labeler

LabelerNUVICARE LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code84324
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio43 products on file
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

🧪 What is this product?

This is an over-the-counter oral tablet formulated under FDA's OTC monograph rules for tension headache relief. It contains acetaminophen, a pain reliever and fever reducer commonly used in headache products, and caffeine, a central nervous system stimulant often included to enhance pain relief and improve alertness. The combination is typically used to address mild to moderate headache symptoms.

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.

💊 What it looks like

Color red
ShapeCapsule
ImprintNone
Size28 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.

💡 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 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

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

The official label also statesColloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tension Headache 500 mg/1; 65 mg 70000-0159-01 Cardinal 24 tablets $0.064 — Availability likely —
Excedrin Tension Headache 500 mg/1; 65 mg 00067-8139-01 Haleon 24 tablets — — FDA listed —
PANADOL Extra 500 mg/1; 65 mg 00135-0620-01 Haleon 24 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 00363-0572-31 Walgreen 80 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 00363-7213-10 WALGREENS 100 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 11673-0839-01 TARGET 100 tablets — — FDA listed —
Tension Headache Aspirin-Free 500 mg/1; 65 mg 11822-0428-02 Rite 100 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 49483-0373-01 TIME 100 tablets — — FDA listed —
DoloDent Toothache For adults 65 mg/1; 500 mg 55758-0435-24 Pharmadel 24 tablets — — FDA listed —
Tension Headache Aspirin Free 500 mg/1; 65 mg 59779-0824-06 CVS 200 tablets — — FDA listed —
DRX CHOICE Tension Headache 500 mg/1; 65 mg 68163-0506-15 Raritan 15 tablets — — FDA listed —
Sed-Max 500 mg/1; 65 mg 69197-0029-20 Command 20 tablets — — FDA listed —
Cafizetamol Forte 500 mg/1; 65 mg 69729-0147-40 OPMX 40 tablets — — FDA listed —
Migrafein FORTE 500 mg/1; 65 mg 69729-0148-40 OPMX 40 tablets — — FDA listed —
Neo-Lubrina Fuerte 500 mg/1; 65 mg 69729-0149-24 OPMX 12 tablets — — FDA listed —
Mejoral 500 mg/1; 65 mg 69729-0154-24 OPMX 12 tablets — — FDA listed —
KORTRIBION Pain Reliever 500 mg/1; 65 mg 69729-0793-24 OPMX 12 tablets — — FDA listed —
Doloneuro-Tropas 500 mg/1; 65 mg 69729-0795-80 OPMX 4 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 69732-0007-01 Hi-Tech 100 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mg 72090-0004-02 Pioneer 200 tablets — — FDA listed —
Tension Headache Pain Relieving Aid 500 mg/1; 65 mg 79903-0373-01 WAL-MART 100 tablets — — FDA listed —
NOTTS - Tension Headache 500 mg/1; 65 mg 82706-0010-01 VIVUNT 24 tablets — — FDA listed —
Tension Headache Relief 500 mg/1; 65 mgthis 84324-0002-01 NUVICARE 100 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
Jul 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.

🔬 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 Tension Headache Relief (this brand).

Top reported reactions

Pain80
Drug Interaction61
Dyspnoea58
Sinusitis57
Lower Respiratory Tract Infection54
Mobility Decreased50
Peripheral Swelling49

Age at onset

Adult29
Elderly5

Reporter sex

212 reports
Male · 6%
Female · 94%

Serious outcomes

Hospitalization100
Life-threatening63
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 42 7
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 NDCDescription Marketing startStatus
84324-0002-01 You're viewing this 100 TABLET in 1 BOTTLE (84324-002-01) 2024-07-30 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 ✓ 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 FDA registers it as 84324-002-01, 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: 84324-0002-01, written without dashes as 84324000201. 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 84324-0002-01, the first segment (84324) is the labeler code FDA assigned to NUVICARE LLC; the middle segment (0002) 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

Uses: temporarily relieves minor aches and pains due to: •headache •muscular aches

⏱️ Dosage and Administration 35 words ▾

DIRECTIONS Do not use more than directed adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours chlidren under 12 years: ask a doctor

⚠️ Warnings 154 words ▾

Warnings: 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. Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take •no more than 6 caplets in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this product Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

DO NOT USE: •if you have ever had an allergic reaction to acetaminophen •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

🧪 Active Ingredient 10 words ▾

Active Ingredients (in each caplet) Acetaminophen 500mg Caffeine 65 mg

🧪 Inactive Ingredients 45 words ▾

INACTIVE INGREDIENTS Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

🎯 Purpose 8 words ▾

Purpose Acetaminophen 500mg................................Pain reliever Caffeine 65mg............................................Pain reliever aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84324-0001-01 · NUVICARE 84324-0003-01 · 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.