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Rugby Chest Congestion Relief PE Guaifenesin/phenylephrine 400 mg; 10 mg Tablet, 60-count — NDC 00536-1309-08 package photo

Rugby Chest Congestion Relief PE Guaifenesin/phenylephrine 400 mg; 10 mg Tablet, 60-count

by Rugby Laboratories · 1 BOTTLE, PLASTIC in 1 CARTON (0536-1309-08) / 60 TABLET in 1 BOTTLE, PLASTIC
NDC 00536-1309-08
🏷️ FDA NDC (as labeled) 0536-1309-08 billing pads the labeler segment with a zero
This package
Contains60-count Cost per ea$0.0903 NADAC Per package$5.42 / 60 tablets Pack sizes2 compare ↓
Also comes in: 30 tablets 00536-1309-07
OTC On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 0536-1309-08
Product NDC 0536-1309
11-digit billing NDC 00536130908
NCPDP billing unit EA — each (per item)
RxCUI 1304111
UNII 495W7451VQ, 04JA59TNSJ
UPC 0305361309084
Application # M012
SPL Set ID 2fb83580-7fe1-41a5-abf6-0dc25520f260
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-09
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
GPI-14 43996202100320
GPI class Chest Congestion Relief PE
GCN Seq No 061571
GCN 97358
HICL code 000250
Ingredient (HICL) Guaifenesin/Phenylephrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4W
Therapeutic class — specific (HIC3) Decongestant-Expectorant Combinations
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name CHEST CONG RLF PE 400-10 MG TB
FDB brand name Chest Congestion Relief Pe
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1309-08 — 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 → 00536-1309-08. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
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.

🏭 Manufacturer & labeler

LabelerRugby Laboratories
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio149 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

Label name CHEST CONG RLF PE 400-10 MG TB Ingredient Guaifenesin/Phenylephrine Hcl
📖 About the active ingredient: Guaifenesin; Phenylephrine Hydrochloride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

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

Rugby Chest Congestion Relief PE is an over-the-counter oral tablet containing guaifenesin and phenylephrine hydrochloride. Guaifenesin is an expectorant typically used to help thin mucus and make coughs more productive. Phenylephrine hydrochloride is a decongestant commonly used to help relieve nasal and sinus congestion. This is an OTC monograph product, meaning it is marketed under the FDA's established rules for this drug category.

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 white
ShapeOval
ImprintPH043
Size17 mm
ScoringScored — splits in 2
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 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 9B9691B2N9
    Magnesium silicate is a mineral compound used in tablets and capsules as a glidant and anti-caking agent. It helps powder ingredients flow smoothly during manufacturing and prevents clumping in the final product.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.

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

The official label also stateslactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin

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 eaPer package
Retail pharmacies payNADAC · weekly $0.090 $5.42 / 60 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
Dec 2021 Jun 2022 Jan 2026 Aug 2026 $0.094 $0.074
▼ Down 1% over the last 20 months.
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
Sunmark Chest Congestion Relief PE PE 400 mg/1; 10 mg 49348-0774-09 Strategic 50 tablets $0.075 — FDA listed save 17%
Rugby Chest Congestion Relief PE 400 mg/1; 10 mgthis 00536-1309-08 Rugby 60 tablets $0.090 — Availability likely —
GNP Mucus Relief PE 400 mg/1; 10 mg 46122-0700-71 AmerisourceBergen 50 tablets $0.090 — Availability likely —
Mucus Relief PE Sinus Congestion 400 mg/1; 10 mg 70000-0141-01 Cardinal 50 tablets $0.090 — Availability likely —
Foster and Thrive Chest Congestion Relief PE PE 400 mg/1; 10 mg 70677-1056-01 Strategic 50 tablets $0.090 — Availability likely —
Mucus Relief PE 400 mg/1; 10 mg 00363-0542-01 Walgreen 30 tablets — — FDA listed —
Topcare Chest Congestion and Sinus Congestion Relief PE 400 mg/1; 10 mg 36800-0989-50 TOPCO 50 tablets — — FDA listed —
Always Save Mucus Relief PE 400 mg/1; 10 mg 63941-0986-50 Valu 50 tablets — — FDA listed —
CVS Health Chest Congestion Relief PE 400 mg/1; 10 mg 69842-0997-60 CVS 60 tablets — — FDA listed —
Pharbinex-PE 400 mg/1; 10 mg 73057-0389-04 Ulai 30 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 Rugby Chest Congestion Relief PE (this brand).

Top reported reactions

Acute Kidney Injury2
Chronic Kidney Disease2
Infection2
Infusion Related Reaction2
Neuropathy Peripheral2
Pain2
Rash2

Age at onset

Adult2

Reporter sex

11 reports
Male · 10%
Female · 90%

Serious outcomes

Hospitalization2
Death1
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 Per unit Per pack Marketing startStatus
00536-1309-07 1 BOTTLE, PLASTIC in 1 CARTON (0536-1309-07) / 30 TABLET in 1 BOTTLE, PLASTIC $0.0805 / ea $2.42 2020-09-09 Active
00536-1309-08 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (0536-1309-08) / 60 TABLET in 1 BOTTLE, PLASTIC $0.0903 / ea $5.42 2020-09-09 Active

Per ea, this pack runs about 12% above the cheapest pack (NDC 00536-1309-07, $0.0805 vs $0.0903 NADAC).

Pack size FAQ

What quantity is in NDC 00536-1309-08?
NDC 00536-1309-08 is a 60-count package — 1 bottle, plastic in 1 carton / 60 tablet in 1 bottle, plastic.
What is the difference between NDC 00536-1309-08 and NDC 00536-1309-07?
Both are Rugby Chest Congestion Relief PE Guaifenesin/phenylephrine 400 mg; 10 mg Tablet — the drug itself is identical. NDC 00536-1309-08 is the 60-count package, while NDC 00536-1309-07 is the 30 tablets package. Per-ea NADAC also differs: $0.0903 here vs $0.0805 for the 30 tablets pack.
What NDC number is used to bill for this package of Rugby Chest Congestion Relief PE Guaifenesin/phenylephrine 400 mg; 10 mg Tablet?
Bill NDC 00536-1309-08 — the 11-digit billing format is 00536130908. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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
🎯 Indications and Usage 47 words ▾

Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive

⏱️ Dosage and Administration 56 words ▾

Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

⚠️ Warnings 6 words ▾

Warnings Do not exceed recommended dosage

🧪 Active Ingredient 12 words ▾

Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton

🎯 Purpose 5 words ▾

Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1308-40 · Rugby 00536-1311-08 · Rugby →
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.