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Tension Headache Relief Acetaminophen, Caffeine 500 mg; 65 mg Tablet, 100-count — NDC 49483-0373-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tension Headache Relief Acetaminophen, Caffeine 500 mg; 65 mg Tablet, 100-count — NDC 49483-373-01 (Billing 49483-0373-01)

by TIME CAP LABS INC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Tension Headache Relief Acetaminophen, Caffeine 500 mg; 65 mg Tablet from TIME CAP LABS INC, marketed since Jun 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 49483-0373-01
🏷️ FDA NDC (as labeled) 49483-373-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 49483-373 · Also comes in: 200 tablets 49483-373-20
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49483-373-01
Product NDC 49483-373
11-digit billing NDC 49483037301
RxCUI 307686
UNII 362O9ITL9D, 3G6A5W338E
Application # M013
SPL Set ID 05364eb4-07a1-a4d9-e063-6294a90a47e5
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 2021-06-16
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CAFFEINE
Quick answers
  • RxCUI (RxNorm): 307686
Why two NDCs? The FDA registers this code as 49483-373-01 — 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 → 49483-0373-01. 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

🧪 What is this product?

This is an over-the-counter tablet taken by mouth that combines acetaminophen with caffeine. Acetaminophen is commonly used to relieve pain and reduce fever, while caffeine functions as a central nervous system stimulant and is often added to pain relievers because it may enhance their effects. This combination is typically marketed for tension headache relief.

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: 200 tablets
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
49483-0373-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2021-06-16 — Active
49483-0373-20 49483-373-20 200 TABLET in 1 BOTTLE 2023-08-08 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 49483-0373-20?
Both are Tension Headache Relief Acetaminophen, Caffeine 500 mg; 65 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 49483-0373-20 is the 200 tablets package.
What NDC number is used to bill for this package of Tension Headache Relief Acetaminophen, Caffeine 500 mg; 65 mg Tablet?
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
Tension Headache 500 mg/1; 65 mg 70000-0159-01 Cardinal 24 tablets $0.062 — 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 mgthis 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 mg 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

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

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII ZK64F7XSTX
    A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • 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.

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

The official label also statesInactive ingredients carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

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

LabelerTIME CAP LABS INC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code49483
First marketedJun 2021
Product typeHuman Otc Drug
Portfolio6 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.

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 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 children under 12 years: ask a doctor

⚠️ Warnings ~1 min read ▾

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 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 are allergic 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 Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if any new symptoms occur painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 17 words ▾

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

🧪 Active Ingredient 11 words ▾

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

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

🎯 Purpose 6 words ▾

Purposes Pain reliever Pain reliever aid

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 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

Serious outcomes

Hospitalization100
Disabling59
Death35
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 37 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
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 TIME CAP LABS INC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 200 tablets (49483-0373-20). 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?
TIME CAP LABS INC 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.
← 49483-0370-00 · TIME 49483-0381-10 · Time-Cap →
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.