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Stonarhini Chlorpheniramine maleate, phenylephrine 2 mg; 5 mg Tablet, 24-count — NDC 49873-0109-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Stonarhini Chlorpheniramine maleate, phenylephrine 2 mg; 5 mg Tablet, 24-count — NDC 49873-109-01 (Billing 49873-0109-01)

by Sato Pharmaceutical Co., Ltd. · 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

This is a package of 24 tablets of Stonarhini Chlorpheniramine maleate, phenylephrine 2 mg; 5 mg Tablet from Sato Pharmaceutical Co., Ltd., marketed since Nov 2001 and currently FDA-listed. It is this product's only package size.

NDC 49873-0109-01
🏷️ FDA NDC (as labeled) 49873-109-01 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 Aug 13, 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) 49873-109-01
Product NDC 49873-109
11-digit billing NDC 49873010901
RxCUI 1242240
UNII V1Q0O9OJ9Z, 04JA59TNSJ
UPC 0349873033037
Application # M012
SPL Set ID cc353280-0b4c-418c-93fe-850125955009
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-11-16
Route ORAL
Dosage form TABLET
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1242240
Why two NDCs? The FDA registers this code as 49873-109-01 — 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 → 49873-0109-01. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists
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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Chlorpheniramine is used to treat allergy symptoms: sneezing runny nose itchy nose or throat red, itchy, watery eyes Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
🧪 What is this product?

Stonarhini is an over-the-counter oral tablet containing chlorpheniramine maleate and phenylephrine hydrochloride. Chlorpheniramine maleate is an antihistamine typically used to relieve allergy symptoms such as sneezing, itching, and runny nose. Phenylephrine hydrochloride is a decongestant commonly used to reduce nasal congestion. This combination product is marketed as an OTC monograph drug, meaning it follows FDA's established standards for this category of cold and allergy relief medicines.

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
49873-0109-01 You're viewing this Main listing 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK 2001-11-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stonarhini 2 mg/1; 5 mgthis 49873-0109-01 Sato 24 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

🏛️
2001
On the market since
Nov 2001
📍
2026
Currently FDA-listed
25 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.

What it looks like

Color red
ShapeRound
ImprintS10
Size1 mm
ScoringNot scored
FlavorMenthol
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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 8VAB711C5E
    Hydroxypropyl cellulose is a plant-based thickener made from cellulose. In medicines, it acts as a binder to hold ingredients together, a coating to protect the tablet or capsule, and a thickener to create the right texture in liquids or gels.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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.

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

The official label also statesInactive ingredients   aspartame, colloidal silicone dioxide, FD&C Red No. 40 aluminum Lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol.

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

LabelerSato Pharmaceutical Co., Ltd.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code49873
First marketedNov 2001
Product typeHuman Otc Drug
Portfolio30 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses Temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis). ■ sneezing ■ runny nose ■ itchy, watery eyes ■ nasal congestion, stuffy nose ■ itchy throat

⏱️ Dosage and Administration 30 words ▾

Directions adults and children 12 years and over: 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours children under 12 years of age: ask a doctor

⚠️ Warnings 199 words ▾

Warnings ​ Enter section text here Do not use this product ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this priduct. Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ heart disease ■ thyroid disease ■ diabetes ■ high blood pressure ■difficulty in urination due to enlargement of the prostate Ask a doctor or pharmacist before use ■ if you are taking sedatives or tranquilizers When using this product ■ do not exceed recommended dosage.

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. ■ you may get drowsy. ■ may cause excitability, especially in children. ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect. ■ avoid alcoholic beverages. ■ use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if ■ symptoms do not improve within seven days ■ symptoms are accompanied by fever

🧪 Active Ingredient 13 words ▾

Active ingredients (In each tablet) Chlorpheniramine Maleate 2 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients aspartame, colloidal silicone dioxide, FD&C Red No. 40 aluminum Lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol.

🎯 Purpose 8 words ▾

Purpose Chlorpheniramine Maleate Antihistamine Phenylephrine HCl Nasal decongestant

📄 Do Not Use 57 words ▾

Do not use this product ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this priduct.

📄 Ask a Doctor Before Use If 41 words ▾

Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ heart disease ■ thyroid disease ■ diabetes ■ high blood pressure ■difficulty in urination due to enlargement of the prostate

📄 Ask a Doctor or Pharmacist Before Use If 15 words ▾

Ask a doctor or pharmacist before use ■ if you are taking sedatives or tranquilizers

📄 When Using This Product 59 words ▾

When using this product ■ do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. ■ you may get drowsy. ■ may cause excitability, especially in children. ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect. ■ avoid alcoholic beverages. ■ use caution when driving a motor vehicle or operating machinery.

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if ■ symptoms do not improve within seven days ■ symptoms are accompanied by fever

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 35 words ▾

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

📄 Package Label / Principal Display Panel 1 words ▾

CARTON

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 Chlorpheniramine maleate, phenylephrine — the ingredient across all brands.

Top reported reactions

Fatigue3,340
Headache3,128
Nausea2,953
Dyspnoea2,943
Diarrhoea2,395
Pain2,365
Dizziness2,209

Reporter sex

49,806 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization11,012
Disabling1,252
Life-threatening928
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,477 1,025
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 Sato Pharmaceutical Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sato Pharmaceutical Co., Ltd. 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.
← 49873-0108-01 · Sato 49873-0113-01 · Sato →
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.