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Duralgina Acetaminophen 325 mg Tablet, 30-count — NDC 53145-013-71 (Billing 53145-0013-71)

by Menper Distributors Inc. · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Duralgina Acetaminophen 325 mg Tablet from Menper Distributors Inc., marketed since Jan 2017 and currently FDA-listed. It is this product's only package size.

NDC 53145-0013-71
🏷️ FDA NDC (as labeled) 53145-013-71 billing pads the product segment with a zero
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

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53145-013-71
Product NDC 53145-013
11-digit billing NDC 53145001371
RxCUI 313782
UNII 362O9ITL9D
UPC 0042279108056
Application # M013
SPL Set ID bb31f66c-80a9-4bdb-983b-cef5d21de5ff
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-01-01
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 313782
Why two NDCs? The FDA registers this code as 53145-013-71 — 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 → 53145-0013-71. 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

📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen 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
53145-0013-71 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2017-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense pain relief 325 mg 00113-0403-78 L. 100 tablets $0.023 — Availability likely —
Rugby Regular Strength Acetaminophen 325 mg 00536-1327-01 RUGBY 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 00904-6773-61 Major 100 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 46122-0390-78 AmeriSource 100 tablets $0.023 — Availability likely —
Acetaminophen Regular Strength 325 mg 46122-0430-78 Amerisource 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 49483-0340-01 TIME 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 57237-0346-01 Rising 100 tablets $0.023 — Availability likely —
McKesson Acetaminophen 325 325 mg 68599-4679-09 McKesson 2 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 70677-1119-01 STRATEGIC 100 tablets $0.023 — Availability likely —
Acetaminophen 325 mg 82568-0001-01 AARNA 100 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 83324-0076-01 CHAIN 100 tablets $0.023 — Availability likely —
Pain Relief Regular Strength 325 mg 63868-0082-10 Chain 100 tablets $0.025 — Discontinued —
Regular Strength Acetaminophen 325 mg 70000-0092-01 CARDINAL 100 tablets $0.026 — FDA listed —
Pain Reliever 325 mg 00363-9026-10 WALGREENS 100 tablets — — FDA listed —
Henry Schein Acetaminophen 325 mg 00404-0714-13 Henry 2 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8397-05 NCS 15 tablets — — Discontinued —
Acetaminophen 325 mg 00615-8398-67 NCS 60 tablets — — Discontinued —
Acetaminophen 325 mg 00615-8608-05 NCS 15 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8609-67 NCS 60 tablets — — FDA listed —
Acetaminophen 325mg 325 mg 10135-0828-01 Marlex 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 11822-0104-01 Rite 100 tablets — — FDA listed —
Pharbetol Regular strength 325 mg 16103-0353-07 Pharbest 60 tablets — — FDA listed —
Acetaminophen 325 mg 17714-0012-01 Advance 100 tablets — — FDA listed —
Pharbetol Regular strength 325 mg 17856-0353-01 ATLANTIC 100 tablets — — FDA listed —
Pain Relief 325 mg 21130-0043-01 BETTER 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 30142-0052-21 KROGER 100 tablets — — FDA listed —
Aurophen Regular Strength 325 mg 30142-0184-21 KROGER 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 36800-0900-02 TopCo 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 41163-0514-02 United 100 tablets — — FDA listed —
Regular Strength Acetaminophen 325 mg 41226-0340-01 KROGER 100 tablets — — FDA listed —
pain relief 325 mg 41250-0403-78 Meijer 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 41250-0501-02 Meijer 100 tablets — — Discontinued —
PAIN RELIEF Regular Strength 325 mg 41520-0606-02 AMERICAN 100 tablets — — FDA listed —
Pain Relief 325 mg 42507-0501-02 HYVEE 100 tablets — — FDA listed —
Medique APAP 325 mg 47682-0057-13 Unifirst 2 tablets — — FDA listed —
Medi-First Non-Aspirin 325 mg 47682-0058-13 Unifirst 2 tablets — — FDA listed —
Medi-First Plus Non-Aspirin 325 mg 47682-0059-33 Unifirst 2 tablets — — FDA listed —
Dover Aminofen 325 mg 47682-0060-13 Unifirst 2 tablets — — FDA listed —
Medique APAP 325 mg 47682-0145-13 Unifirst 2 tablets — — FDA listed —
Dover Aminophen 325 mg 47682-0303-13 Unifirst 2 tablets — — FDA listed —
Medique at Home APAP 325 mg 47682-0434-33 Unifirst 2 tablets — — FDA listed —
Medi-First Non-Aspirin 325 mg 47682-0803-13 Unifirst 2 tablets — — FDA listed —
MEDI FIRST PLUS Non-Aspirin 325 mg 47682-0903-33 Unifirst 2 tablets — — FDA listed —
Ringl 325 mg 49873-0082-01 Sato 30 tablets — — FDA listed —
Rugby Regular Strength Acetaminophen 325 mg 50090-5971-06 A-S 50 tablets — — FDA listed —
Cetafen 325 mg 50332-0148-01 HART 1000 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0458-10 Kenvue 1000 tablets — — Discontinued —
TYLENOL Regular Strength 325 mg 50580-0475-10 Kenvue 1000 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0495-01 Kenvue 100 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0496-60 Kenvue 100 tablets — — FDA listed —
MEDIQUE APAP acetaminophen 325 mg 51662-1273-02 HF 2 tablets — — FDA listed —
acetaminophen 325 mg 51662-1665-02 HF 2 tablets — — FDA listed —
CareALL Acetaminophen 325 mg 51824-0061-02 New 2400 tablets — — FDA listed —
CareALL Acetaminophen 325 mg 51824-0085-01 New 100 tablets — — FDA listed —
Duralgina 325 mgthis 53145-0013-71 Menper 30 tablets — — FDA listed —
Clear Choice Regular Strength Pain Reliever 325 mg 53185-0005-00 Athlete's 100 tablets — — FDA listed —
Medline 325 mg 53329-0194-30 Medline 100 tablets — — FDA listed —
Pain Relief 325 mg 53942-0101-02 Demoulas 100 tablets — — FDA listed —
Pain Relief 325 mg 53943-0201-02 DISCOUNT 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 54257-0720-02 Magno-Humphries, 100 tablets — — FDA listed —
Acetaminophen 325 mg 54738-0548-01 Richmond 100 tablets — — FDA listed —
Acetaminophen 325 mg 55154-7899-00 Cardinal 10 tablets — — FDA listed —
Acetaminophen Regular strength 325 mg 55289-0563-01 PD-Rx 100 tablets — — FDA listed —
dg health pain relief 325 mg 55910-0697-78 Dolgencorp, 100 tablets — — FDA listed —
Pain Relief 325 mg 57344-0301-06 AAA 500 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 57896-0102-01 Geri-Care 100 tablets — — FDA listed —
Acetaminophen 325 mg 58228-0061-01 Prostat 20000 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 58602-0748-40 Aurohealth 500 tablets — — FDA listed —
Aurophen Regular Strength 325 mg 58602-0754-07 Aurohealth 24 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 58602-0775-21 Aurohealth 100 tablets — — FDA listed —
Travel Savvy Non-Aspirin 325 mg 59961-0151-15 Bellegrove 2 tablets — — FDA listed —
Direct Safety Aspirin Free 325 mg 61245-0145-13 Conney 2 tablets — — FDA listed —
Regular Strength Pain Reliever 325 mg 62936-0102-01 INGLES 100 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 63941-0456-02 VALU 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 67091-0132-10 WinCo 100 tablets — — FDA listed —
Acetaminophen 325 mg 68071-3454-03 NuCare 30 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 68071-3565-00 NuCare 100 tablets — — FDA listed —
good sense pain relief 325 mg 68071-3883-02 NuCare 20 tablets — — FDA listed —
good sense pain relief 325 mg 68071-3917-06 NuCare 6 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 68071-4656-05 NuCare 50 tablets — — FDA listed —
DRX CHOICE Regular Strength 325 mg 68163-0065-60 Raritan 60 tablets — — FDA listed —
good sense pain relief 325 mg 68788-8821-01 Preferred 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 68998-0301-01 MARC 100 tablets — — FDA listed —
Acetaminophen 325mg RS 325 mg 69168-0010-30 Allegiant 30 tablets — — FDA listed —
Acetaminophen 325 Mg 69618-0010-01 Reliable 100 tablets — — FDA listed —
Acetaminophen 325 mg 69822-0692-10 Southern 325 tablets — — Discontinued —
Acetaminophen Regular Strength 325 mg 69842-0876-51 CVS 365 tablets — — FDA listed —
Acetaminophen 325 mg 69842-0968-01 CVS 100 tablets — — FDA listed —
Regular Strength Pain Reliever 325 mg 70677-1243-01 Strategic 120 tablets — — FDA listed —
MEDI-FIRST Non-Aspirin 325 mg 71205-0306-04 Proficient 4 tablets — — FDA listed —
Acetaminophen 325 Mg 71205-0456-00 Proficient 100 tablets — — FDA listed —
good sense pain relief 325 mg 71335-2574-01 Bryant 100 tablets — — FDA listed —
Acetaminophen 325 mg 71335-2747-00 Bryant 24 tablets — — FDA listed —
Acetaminophen 325 mg 71335-3130-00 Bryant 24 tablets — — FDA listed —
Acetaminophen 325 mg 71399-1025-01 Akron 100 tablets — — FDA listed —
Acetaminophen 325 mg 71610-0238-65 Aphena 100 tablets — — FDA listed —
Acetaminophen 325 mg 71679-0305-00 Health 47000 tablets — — FDA listed —
Acetaminophen 325 mg 72036-0100-02 HARRIS 100 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 72162-2252-01 Bryant 100 tablets — — FDA listed —
basic care acetaminophen 325 mg 72288-0403-78 Amazon.com 100 tablets — — FDA listed —
Amazon Basic Care Acetaminophen 325 mg 72288-0405-10 Amazon.com 100 tablets — — FDA listed —
Acetaminophen 325 mg 72789-0267-20 PD-Rx 20 tablets — — FDA listed —
Pharbetol 325 mg 73057-0353-08 Ulai 100 tablets — — FDA listed —
Aphen 325 mg 76420-0372-15 Asclemed 150 tablets — — FDA listed —
Pain Reliever 325 mg 79903-0130-99 WAL-MART 100 tablets — — FDA listed —
equate pain reliever 325 mg 79903-0299-10 WALMART 100 tablets — — FDA listed —
Dr Simi Pain Relief 325 mg 85786-0103-90 Farmacias 100 tablets — — FDA listed —
Acetaminophen 325 mg 85828-0102-02 Grocery 100 tablets — — FDA listed —
Acetaminophen 325 mg 69732-0002-01 Hi-Tech 30 tablets — — FDA listed —
Pain Relief Acetaminophen 325 mg 84324-0046-01 NUVICARE 300 tablets — — FDA listed —
Gencare- Pain Relief Acetaminophen 325 mg 72090-0069-01 Pioneer 1000 tablets — — FDA listed —
Medline 325 mg 53329-0199-09 Medline 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

LabelerMenper Distributors Inc.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code53145
First marketedJan 2017
Product typeHuman Otc Drug
Portfolio11 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses For the temporary relief of minor aches and pains associated with headache muscular aches minor arthritis pain menstrual cramps common cold temporarily reduces fever backaches toothaches

⏱️ Dosage and Administration 73 words ▾

Directions: Do not take more than directed (see overdose warning) Adults and children12 years and over Take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor Children ages 6-11 Take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor Under 6 years of age Ask a doctor

⚠️ Warnings 144 words ▾

Warnings: Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take more than12 tablets in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day. Do not use: with any other drug conatining acetaminophen (prescription or non-prescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are allergic to acetaminophen or any of the inactive ingredients in the product. Ask a doctor before use if you have liver disease Ask a docor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using this product and ask a doctor if: Pain gets worse or lasts more than 10 days Fever gets worse or lasts more than 3 days New symptoms occur Redness or swelling is persistent These could be signs of a serious condition

🧪 Active Ingredient 8 words ▾

Active Ingredient (in each tablet) Acetaminophen 325 mg

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients Magnesium stearate, povidone, silicone dioxide, sodium carboxymethyl, starch, stearic acid

🎯 Purpose 4 words ▾

Purpose Pain reliever/Fever reducer

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 46 words ▾

Keep out of reach of children. Overdose warning: 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.

📄 Questions or Comments 8 words ▾

Questions: Call 1-800-560-5223 M-F 9AM - 4PM Eastern

📄 Package Label / Principal Display Panel 2 words ▾

image description

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Duralgina (this brand).

Top reported reactions

Fatigue20,900
Pain18,465
Nausea18,163
Headache17,128
Toxicity To Various Agents15,843
Dyspnoea15,012
Pyrexia14,572

Age at onset

Neonate562
Infant376
Child2,615
Adolescent2,132
Adult26,646
Elderly17,765

Reporter sex

253,607 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization114,300
Death49,981
Life-threatening21,905
Disabling12,022
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,614 12,589
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Menper Distributors Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Menper Distributors 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.
← 53145-0009-30 · Menper 53145-0017-28 · MENPER →
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.