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DRX CHOICE Tension Headache Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated, 15-count — NDC 68163-0506-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DRX CHOICE Tension Headache Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated, 15-count — NDC 68163-506-15 (Billing 68163-0506-15)

by Raritan Pharmaceuticals Inc. · 1 BOTTLE in 1 CARTON / 15 TABLET, FILM COATED in 1 BOTTLE

This is a package of 15 tablets of DRX CHOICE Tension Headache Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated from Raritan Pharmaceuticals Inc., marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 68163-0506-15
🏷️ FDA NDC (as labeled) 68163-506-15 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 68163-506-15 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68163 labeler · 506 product · 15 package
Package marketed since
May 16, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0368163065152
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68163-506-15
Product NDC 68163-506
11-digit billing NDC 68163050615
RxCUI 307686
UNII 362O9ITL9D, 3G6A5W338E
UPC 0368163065152
Application # M013
SPL Set ID 8a5cb38b-669d-4177-b33b-d73c7ef48d18
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 2025-05-16
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; CAFFEINE
Quick answers
  • RxCUI (RxNorm): 307686
Why two NDCs? The FDA registers this code as 68163-506-15 — 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 → 68163-0506-15. 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?

DRX Choice Tension Headache is an over-the-counter tablet containing acetaminophen and caffeine. Acetaminophen is typically used to help reduce pain and fever, while caffeine is a central nervous system stimulant commonly added to pain relievers to enhance their effect. This combination is marketed for use in managing tension headaches. The tablet has a film coating to make it easier to swallow.

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
68163-0506-15 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 15 TABLET, FILM COATED in 1 BOTTLE 2025-05-16 — Active

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 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 mgthis 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

🏛️
2025
On the market since
May 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.

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.

Manufacturer & labeler

LabelerRaritan Pharmaceuticals Inc.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code68163
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from Raritan Pharmaceuticals Inc. labeler code 68163

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 📄 Do Not Use 📄 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses temporarily relieves minor aches and pain due to: headache muscular aches

⏱️ Dosage and Administration 37 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 ~2 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 at 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.

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.

🧪 Active Ingredient 11 words ▾

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

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients Colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27, FD&C blue no. 2, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

🎯 Purpose 6 words ▾

Purposes Pain reliever Pain reliever aid

📄 Do Not Use 33 words ▾

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 10 words ▾

Ask a doctor before use if you have liver disease

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 Stop Use and Ask a Doctor If 45 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 45 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-467-2748

📄 Package Label / Principal Display Panel 96 words ▾

Principal Display Panel Compare to Excedrin® Tension Headache active ingredients * NDC 68163-506-15 DRx Choice tension headache relief ASPIRIN-FREE Acetaminophen 500 mg, Caffeine 65 mg Pain Reliever / Pain Reliever Aid ACTUAL SIZE 15 CAPLETS TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING. IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by Haleon CH Sarl., owner of the registered trademark Excedrin Tension Headache.

DRx Choice Tension Headache Relief 15 caplets

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 DRX CHOICE Tension Headache (this brand).

Top reported reactions

Balance Disorder2
Blood Calcium Decreased2
Cognitive Disorder2
Constipation2
Creatinine Renal Clearance Decreased2
Depressed Level Of Consciousness2
Fall2

Age at onset

Adult1

Reporter sex

4 reports
Female · 100%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 3 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) — 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 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 Raritan Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Raritan Pharmaceuticals 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.
← 68163-0307-06 · RARITAN 68163-0515-48 · Raritan →
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.