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Defensolito Acetaminophen, Phenylephrine Hydrochloride 80 mg; 2.5 mg Tablet, Chewable — NDC 53145-0006-02 package photo

Defensolito Acetaminophen, Phenylephrine Hydrochloride 80 mg; 2.5 mg Tablet, Chewable

by Menper Distributors, Inc. · 50 PACKET in 1 CARTON (53145-006-02) / 2 TABLET, CHEWABLE in 1 PACKET
NDC 53145-0006-02
🏷️ FDA NDC (as labeled) 53145-006-02 billing pads the product segment with a zero
This package
Contains2 tablet, chewable in 1 packet Pack sizes2 compare ↓
Also comes in: 30 tablets 53145-0006-30
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 53145-006-02
Product NDC 53145-006
11-digit billing NDC 53145000602
RxCUI 1539545
UNII 362O9ITL9D, 04JA59TNSJ
Application # M012
SPL Set ID 2a3f498d-445f-410b-818f-9f119bd6c492
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2012-02-21
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 53145-006-02 — 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 → 53145-0006-02. 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.

🏭 Manufacturer & labeler

LabelerMenper Distributors, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53145
First marketedFeb 2012
Product typeHuman Otc Drug
Portfolio26 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?

Defensolito is a chewable tablet taken by mouth that contains acetaminophen and phenylephrine hydrochloride. Acetaminophen is typically used to relieve pain and reduce fever. Phenylephrine hydrochloride is a decongestant commonly included in cold and sinus products to help relieve nasal congestion. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for its drug category rather than through an individual product application.

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 pink
ShapeRound
Size1 mm
ScoringScored — splits in 2
FlavorCherry
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 Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII 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 58QVG85GW3
    A synthetic polymer made from vinyl acetate and phthalic acid. It coats tablets and capsules to control when and where the medicine dissolves in the digestive system, protecting the contents from stomach acid.
  • 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 81H2R5AOH3
    A natural sweetener and carbohydrate derived from sugarcane plants. In medicines, it sweetens the taste to improve palatability and may serve as a bulking agent or binder in tablets and powders.
  • 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.

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

The official label also statesInactive Ingredients Aspartame, Carboxymethylcellulose Sodium, FD&C #40 aluminum lake, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and 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.
Try another pack size: 30 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Defensolito 80 mg/1; 2.5 mgthis 53145-0006-02 Menper 2 tablets — — Discontinued —
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

🏛️
2012
On the market since
Feb 2012
📍
2026
Currently FDA-listed
14 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 Acetaminophen, Phenylephrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Vomiting8
Diarrhoea7
Anxiety6
Fatigue6
Insomnia6
Nausea6
Covid-195

Age at onset

Adult3
Elderly1

Reporter sex

0 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization23
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53145-0006-02 You're viewing this 50 PACKET in 1 CARTON (53145-006-02) / 2 TABLET, CHEWABLE in 1 PACKET 2012-02-21 Inactivated by FDA
53145-0006-30 1 BOTTLE in 1 BOX (53145-006-30) / 30 TABLET, CHEWABLE in 1 BOTTLE 2012-02-21 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 53145-0006-02?
NDC 53145-0006-02 is listed by the FDA — 50 packet in 1 carton / 2 tablet, chewable in 1 packet.
What NDC number is used to bill for this package of Defensolito Acetaminophen, Phenylephrine Hydrochloride 80 mg; 2.5 mg Tablet, Chewable?
Bill NDC 53145-0006-02 — the 11-digit billing format is 53145000602. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 53145-006-02, 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: 53145-0006-02, written without dashes as 53145000602. 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 53145-0006-02, the first segment (53145) is the labeler code FDA assigned to Menper Distributors, Inc.; the middle segment (0006) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (53145-0006-30). 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?
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.

📄 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 38 words ▾

Uses Temporarily relieves nasal decongestion due to a common cold, hay fever or other upper respiratory allergies, nasal stuffiness, sinus congestion and pressure minor aches and pains associated with the common cold, sore throat, headache, tootheache and flu

⏱️ Dosage and Administration 40 words ▾

Directions Do not take more than 6 doses (12 chewable tablets) in a 24 hour period Children 6 to under 12 years of age take 2 chewable tablets every 4 hours Children under 6 years of age consult a doctor

⚠️ Warnings 92 words ▾

Warnings Do not exceed recommended dosage. Do not give to children under 6 years of age. Liver toxicity may occur if recommended dosage is exceeded used with other products containing acetaminophen used with moderate amounts of alcohol Drug Interaction Precaution: Do not use in a child who is taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or Parkinson's Disease), or for two weeks after stopping the MAOI drug.

If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

🆘 Overdosage 36 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

🧪 Active Ingredient 12 words ▾

Active ingredients (in each tablet) Acetaminophen 80 mg Phenylephrine Hydrochloride 2.5 mg

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients Aspartame, Carboxymethylcellulose Sodium, FD&C #40 aluminum lake, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and Talc.

🎯 Purpose 7 words ▾

Purpose Pain reliever/ Fever Reducer Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53145-0005-02 · Menper 53145-0009-30 · 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.