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Rugby Chest Congestion Relief G450 Guaifenesin 400 mg Tablet, 60-count — NDC 00536-1311-08 package photo

Rugby Chest Congestion Relief G450 Guaifenesin 400 mg Tablet, 60-count

by Rugby Laboratories · 60 TABLET in 1 BOTTLE, PLASTIC (0536-1311-08)
NDC 00536-1311-08
🏷️ FDA NDC (as labeled) 0536-1311-08 billing pads the labeler segment with a zero
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) 0536-1311-08
Product NDC 0536-1311
11-digit billing NDC 00536131108
NCPDP billing unit EA — each (per item)
RxCUI 359601
UNII 495W7451VQ
Application # M012
SPL Set ID a6aa8cbd-21ff-4f84-b338-c05c2d46e6df
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 2020-09-01
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN
GPI-14 43200010000340
GPI class Chest Congestion Relief
GCN Seq No 051583
GCN 18906
HICL code 000271
Ingredient (HICL) Guaifenesin
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3J
Therapeutic class — specific (HIC3) Expectorants
AHFS code 48:16.00.00
AHFS class Expectorants
FDB label name CHEST CONGEST RLF 400 MG TAB
FDB brand name Chest Congestion Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1311-08 — 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 → 00536-1311-08. 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 CONGEST RLF 400 MG TAB Ingredient Guaifenesin
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin is what's called an expectorant — it works to thin and loosen the mucus sitting in your chest and airways. That makes it easier to cough the mucus up and out, so instea...
  • What exactly does guaifenesin do for my cough?
  • Guaifenesin is meant for short-term use. If your cough isn't getting better after 7 days, keeps coming back, or shows up alongside a fever, rash, or a headache that won't go away,...
  • How long can I take it before I should call my doctor?
📖 Read our full Guaifenesin guide →
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
ImprintPH063
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 D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesmagnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

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 $0.065 $3.92 / 60 tablets
Medicaid paysCMS SDUD · 12 mo $0.2389 $14.33 / 60 tablets
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 Jul 2022 Dec 2025 Aug 2026 $0.071 $0.061
▲ Up 1% over the last 24 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
Quality Choice Mucus Relief 400 mg 63868-0998-50 Chain 50 tablets $0.063 — FDA listed save 3%
Rugby Chest Congestion Relief G450 400 mgthis 00536-1311-08 Rugby 60 tablets $0.065 — Availability likely —
Good Neighbor Pharmacy Mucus Relief 400 mg 24385-0602-65 AmerisourceBergen 30 tablets $0.065 — Availability likely —
Guaifenesin 400 mg 24689-0144-01 APNAR 100 tablets $0.065 — Availability likely —
Mucus Relief 400 mg 46122-0794-61 Amerisource 50 tablets $0.065 — Availability likely —
Leader Chest Congestion Relief G450 400 mg 70000-0055-01 Cardinal 60 tablets $0.065 — Availability likely —
Foster and Thrive Chest Congestion Relief 400 mg 70677-1054-01 Strategic 50 tablets $0.065 — Availability likely —
HealthMart Chest Congestion Relief 400 mg 62011-0060-01 Strategic 50 tablets $0.066 — FDA listed +1%
Chest Congestion Relief 400 mg 49348-0729-09 Strategic 24 tablets $0.067 — Availability likely +2%
Mucus Relief 400 mg 00363-0532-01 Walgreen 30 tablets — — FDA listed —
Guaifenesin 400mg 400 mg 10135-0790-30 Marlex 30 tablets — — FDA listed —
DG Health Immediate Release Mucus Relief 400 mg 10956-0059-30 Reese 30 tablets — — FDA listed —
Refenesen Mucus Relief 400 mg 10956-0845-30 Reese 30 tablets — — FDA listed —
Guaifenesin 400 mg 16103-0379-04 Pharbest 30 tablets — — FDA listed —
Mucus Relief 400 mg 17714-0152-01 Advance 100 tablets — — FDA listed —
Kroger Mucus Relief 400 mg 30142-0471-30 THE 30 tablets — — FDA listed —
TopCare Chest Congestion Relief 400 mg 36800-0794-50 TOPCO 50 tablets — — FDA listed —
Mucus Relief 400 mg 37835-0401-40 Bi-Mart 40 tablets — — FDA listed —
Equaline Chest Congestion Relief 400 mg 41163-0113-50 United 50 tablets — — FDA listed —
Mucus Relief 400 mg 41226-0272-03 KROGER 30 tablets — — FDA listed —
Meijer Chest Congestion Relief 400 mg 41250-0713-50 Meijer 50 tablets — — FDA listed —
Mucosa 400 mg 49483-0272-00 TIME 100000 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 50804-0371-30 Good 30 tablets — — FDA listed —
Mucus Relief 400 mg 50804-0857-30 Good 30 tablets — — Discontinued —
Respiratory Relief 400 mg 53499-5295-00 Schwabe 30 tablets — — FDA listed —
Mucosa Guifenesin 400 mg 54257-0776-21 Magno-Humphries, 60 tablets — — FDA listed —
Mucus Relief 400 mg 54738-0981-30 Richmond 30 tablets — — FDA listed —
Family Wellness Chest Congestion Relief 400 mg 55319-0891-30 Family 30 tablets — — FDA listed —
Mucus Relief 400 mg 55681-0311-03 TWIN 300 tablets — — FDA listed —
Guaifenesin 400 400 mg 57631-0012-00 InvaTech 28000 tablets — — FDA listed —
Mucus Relief 400 mg 57896-0714-01 Geri-Care 100 tablets — — FDA listed —
Mucus Relief 400 mg 57896-0794-01 Geri-Care 100 tablets — — FDA listed —
Always Save Chest Congestion Relief GUAF 400 mg 63941-0987-50 Valu 50 tablets — — FDA listed —
Mucus Relief 400 mg 66424-0001-01 SDA 100 tablets — — FDA listed —
Mucus Relief 400 mg 68210-4158-01 Prodose, 15 tablets — — FDA listed —
Marcs Mucus Relief 400 mg 68998-0845-50 Marc 50 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 69168-0370-01 Allegiant 100 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 69168-0916-60 Allegiant 60 tablets — — Discontinued —
Mucus Relief 400 mg 69517-0005-02 HealthLife 200 tablets — — Discontinued —
Guaifenesin 400 mg 69618-0061-06 Reliable 60 tablets — — FDA listed —
Mucus Relief 400 mg 71335-1035-01 Bryant 30 tablets — — FDA listed —
Mucus Relief 400 mg 71335-2032-01 Bryant 30 tablets — — FDA listed —
Guaifenesin 400 mg 71335-9616-01 Bryant 30 tablets — — FDA listed —
Mucus Relief 400 mg 71679-0119-02 Health 200 tablets — — FDA listed —
Guaifenesin 400 mg 71679-0309-00 Health 38500 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0009-02 Pioneer 300 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0013-01 Pioneer 200 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0019-01 Pioneer 200 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0035-01 Pioneer 200 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0044-01 Pioneer 200 tablets — — FDA listed —
Pharbinex 400 mg 73057-0379-04 Ulai 30 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 76162-0004-01 TopCo 100 tablets — — FDA listed —
SIMPEX Guaifenesin 400 mg 76457-0004-00 Simpex 100 tablets — — FDA listed —
Guaifenesin 400Mg Caplets 400 mg 77333-0360-10 Gendose 100 tablets — — FDA listed —
Chest Congestion Relief 400 mg 79481-0714-05 Meijer, 50 tablets — — FDA listed —
Mucus Relief 400 mg 82725-1012-01 Cabinet 200 tablets — — FDA listed —
Quality Choice Mucus Relief 400 mg 83324-0194-50 Chain 50 tablets — — FDA listed —
Mucus Relief 400 mg 84324-0009-01 NUVICARE 100 tablets — — FDA listed —
Mucus Relief 400 mg 57896-0718-01 Geri-Care 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-1311-08, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
106.1K
Units reimbursed last 4 qtrs
6.1M
Gross reimbursed last 4 qtrs
$1.45M
Avg / prescription
$13.64
Avg / unit
$0.2389
Latest quarter Q4 2025
55.9KRx
Medicaid pays / ea
$0.2389
gross reimbursed
vs
NADAC / ea
$0.0653
acquisition cost
=
Spread
+$0.1736
+266% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
95% FFS
Fee-for-service · 100,268 Rx Managed care · 5,794 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 24,094 units · 308 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 39,605 units · 690 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,927 units · 49.1 per 100k residents MI New York: 148,518 units · 759 per 100k residents NY Vermont: 864 units · 134 per 100k residents VT New Hampshire: no data reported NH Oregon: 9,521 units · 225 per 100k residents OR Nevada: 7,832 units · 245 per 100k residents NV Wyoming: 1,170 units · 200 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 27,026 units · 394 per 100k residents IN Ohio: 44,818 units · 380 per 100k residents OH Pennsylvania: 7,888 units · 60.9 per 100k residents PA New Jersey: 13,027 units · 140 per 100k residents NJ Massachusetts: no data reported MA California: 5,492,973 units · 14,097 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 12,778 units · 646 per 100k residents NE Missouri: no data reported MO Kentucky: 141,117 units · 3,118 per 100k residents KY West Virginia: 10,441 units · 590 per 100k residents WV Virginia: 16,930 units · 194 per 100k residents VA Maryland: 3,499 units · 56.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: 1,565 units · 143 per 100k residents RI Arizona: 26,966 units · 363 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 499 units · 7.0 per 100k residents TN North Carolina: no data reported NC South Carolina: 812 units · 15.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,014 units · 9.2 per 100k residents GA D.C.: no data reported DC Hawaii: 7,448 units · 519 per 100k residents HI Texas: 12,070 units · 39.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.014,097
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 14,097 /100k
2 Kentucky 3,118 /100k
3 New York 759 /100k
4 Minnesota 690 /100k
5 Nebraska 646 /100k
6 West Virginia 590 /100k
7 Hawaii 519 /100k
8 Indiana 394 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 G450 (this brand).

Top reported reactions

Dyspnoea561
Pneumonia528
Nausea479
Fatigue450
Pain423
Diarrhoea402
Cough368

Age at onset

Neonate2
Infant2
Child20
Adolescent19
Adult530
Elderly535

Reporter sex

7,221 reports

Serious outcomes

Hospitalization2,887
Life-threatening332
Disabling195
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 591 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
00536-1311-08 You're viewing this 60 TABLET in 1 BOTTLE, PLASTIC (0536-1311-08) 2020-09-01 Active

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make coughs more productive

⏱️ Dosage and Administration 60 words ▾

Directions Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed Children under 6 years of age: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor

⚠️ Warnings 28 words ▾

Warnings Ask doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)

📦 Storage and Handling 6 words ▾

Other Information store at 15°-30°C (59°-86°F)

🧪 Active Ingredient 6 words ▾

Active ingredient (per tablet) Guaifenesin 400mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

🎯 Purpose 2 words ▾

Purpose Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1309-07 · Rugby 00536-1312-08 · 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.