Home › NDC Lookup › Ingredients › Dexchlorpheniramine Maleate And Phenylep... › 00485-0080-01
⚪image loading
(from DailyMed)

Rymed Dexchlorpheniramine Maleate and Phenylephrine Hydrochloride 2 mg; 10 mg Tablet, Coated, 100-count — NDC 0485-0080-01 (Billing 00485-0080-01)

by EDWARDS PHARMACEUTICALS, INC. · 100 TABLET, COATED in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Rymed Dexchlorpheniramine Maleate and Phenylephrine Hydrochloride 2 mg; 10 mg Tablet, Coated from EDWARDS PHARMACEUTICALS, INC., marketed since Nov 2011 and currently FDA-listed; retail pharmacies pay about $0.2240 per tablet (NADAC). It is this product's only package size.

NDC 00485-0080-01
🏷️ FDA NDC (as labeled) 0485-0080-01 billing pads the labeler 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0485-0080-01
Product NDC 0485-0080
11-digit billing NDC 00485008001
NCPDP billing unit EA — each (per item)
RxCUI 2184108
UNII B10YD955QW, 04JA59TNSJ
UPC 3004850080011
Application # M012
SPL Set ID c1d6e914-74cc-4cdf-9587-7eaaa4a386e5
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-11-15
Route ORAL
Dosage form TABLET, COATED
Substance DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43993002480320
GPI class Rymed
GCN Seq No 066243
GCN 28476
HICL code 034893
Ingredient (HICL) Dexchlorpheniram/Phenylephrine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2N
Therapeutic class — specific (HIC3) 1St Gen Antihistamine And Decongestant Combination
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name RYMED TABLET
FDB brand name Rymed
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 066243
  • GCN: 28476
  • GPI-14 (Medi-Span): 43993002480320
  • HICL (First Databank): 034893
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 2184108
Why two NDCs? The FDA registers this code as 0485-0080-01 — a 4-4-2 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 labeler segment → 00485-0080-01. 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 Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines
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

Label name RYMED TABLET Ingredient Dexchlorpheniram/Phenylephrine
🧪 What is this product?

Rymed Dexchlorpheniramine Maleate and Phenylephrine Hydrochloride is an over-the-counter coated tablet taken by mouth. It contains dexchlorpheniramine maleate, an antihistamine commonly used to help relieve allergy symptoms such as sneezing, itching, and runny nose, and phenylephrine hydrochloride, a decongestant typically used to reduce nasal congestion. This is an OTC monograph product, meaning it is marketed under FDA's established guidelines for this category of combination cold and allergy relief products.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.224 $22.40 / 100 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 $0.224 $0.224
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
00485-0080-01 You're viewing this Main listing 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2011-11-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rymed 2 mg/1; 10 mgthis 00485-0080-01 EDWARDS 100 tablets $0.224 — Availability likely —
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

🏛️
2011
On the market since
Nov 2011
📍
2026
Currently FDA-listed
15 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 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 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 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.

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

The official label also statesMagnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

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

LabelerEDWARDS PHARMACEUTICALS, INC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00485
First marketedNov 2011
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 📄 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 70 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor.

⚠️ Warnings 209 words ▾

Warnings Do not exceed recommended dosage. 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness 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 nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

🧪 Active Ingredient 17 words ▾

Active Ingredients (in each tablet) Purpose Dexchlorpheniramine Maleate 2 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

🎯 Purpose 17 words ▾

Active Ingredients (in each tablet) Purpose Dexchlorpheniramine Maleate 2 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant

📄 Do Not Use 62 words ▾

Do not exceed recommended dosage. 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 37 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

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

📄 When Using This Product 35 words ▾

When using this product excitability may occur, especially in children may cause drowsiness 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 28 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

📄 Questions or Comments 5 words ▾

Questions or Comments? Call 1-800-543-9560

📄 Package Label / Principal Display Panel 91 words ▾

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label E NDC 0485-0080-01 RYMED TABLETS Antihistamine • Nasal Decongestant Each tablet contains: Dexchlorpheniramine Maleate 2 mg Phenylephrine HCl 10 mg This bottle is not to be dispensed to consumer. Dispense in a tight, light-resistant container with a child-resistant cap. Store at 59°-86° (15°-30°C) [see USP Controlled Room Temperature].

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Manufactured for: EDWARDS Pharmaceuticals, Inc.

Ripley, MS 38663 100 tablets Principal Display Panel - 100 Tablet Bottle Label

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 RYMED (this brand).

Top reported reactions

Anxiety2
Blood Glucose Decreased2
Chronic Kidney Disease2
Hypertension2
Pain2
Renal Failure2
Accident1

Reporter sex

14 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6 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.
← 00485-0057-08 · EDWARDS 00485-0098-16 · EDWARDS →
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.