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Chest Congestion Relief Guaifenesin 100 mg/5mL Liquid, 473 mL — NDC 00536-1314-85 package photo

Chest Congestion Relief Guaifenesin 100 mg/5mL Liquid, 473 mL

by RUGBY LABORATORIES · 473 mL in 1 BOTTLE (0536-1314-85)
NDC 00536-1314-85
🏷️ FDA NDC (as labeled) 0536-1314-85 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) 0536-1314-85
Product NDC 0536-1314
11-digit billing NDC 00536131485
NCPDP billing unit ML — per mL (volume)
RxCUI 310604
UNII 495W7451VQ
UPC 0305361314859
Application # M012
SPL Set ID 51b088bc-b44f-44b9-a08e-133509a35a2c
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 2020-10-01
Route ORAL
Dosage form LIQUID
Substance GUAIFENESIN
GPI-14 43200010000910
GPI class Chest Congestion Relief
GCN Seq No 022210
GCN 02512
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 CONGESTION RELIEF SOLN
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 0536-1314-85 — 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 → 00536-1314-85. 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 marketedOct 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 CONGESTION RELIEF SOLN 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.

🧪 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesInactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose

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 mLPer package
Retail pharmacies payNADAC · weekly $0.011 $5.30 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0363 $17.17 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.014 $0.009
▼ Down 4% over the last 23 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
Chest Congestion Relief 100 mg/5mLthis 00536-1314-85 RUGBY 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mL 58657-0508-16 Method 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mL 83720-0503-16 Oncor 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mL 58657-0509-16 Method 473 ml $0.013 — FDA listed +19%
Good Neighbor Adult Tussin Mucus and chest congestion 200 mg/10mL 46122-0785-29 AMERISOURCE 1 bottle $0.023 — Availability likely +105%
Tusnel EX 100 mg/5mL 54859-0507-04 Llorens 118 ml $0.023 — Availability likely +105%
Mucolyte 100 mg/5mL 57237-0359-12 Rising 118 ml $0.023 — Availability likely +105%
Tussin 200 mg/10mL 70677-1186-01 Strategic 1 bottle $0.023 — Availability likely +105%
Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 82568-0012-04 AARNA 1 bottle $0.023 — Availability likely +105%
QCH Adult Tussin 541 200 mg/10mL 83324-0024-04 Chain 1 bottle $0.023 — Availability likely +105%
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor 400 mg/20mL 63824-0537-66 Reckitt 180 ml $0.061 — FDA listed +443%
Guaifenesin 100 mg/5mL 00121-0744-04 PAI 118 ml — — FDA listed —
Guaifenesin 200 mg/10mL 00121-1488-00 PAI 10 cups — — FDA listed —
Guaifenesin 100 mg/5mL 00121-1744-00 PAI 10 cups — — FDA listed —
Guaifenesin 300 mg/15mL 00121-2232-00 PAI 10 cups — — FDA listed —
Walgreen Cherry 200 mg/10mL 00363-7043-08 WALGREEN 1 bottle — — FDA listed —
Childrens Chest Congestion Relief 100 mg/5mL 00363-7504-04 WALGREENS 1 bottle — — FDA listed —
Tusnel EX 100 mg/5mL 50090-6542-00 A-S 118 ml — — FDA listed —
CVS Adult Mucus plus Chest Congestion 200 mg/10mL 51316-0437-08 CVS 1 bottle — — FDA listed —
CVS Adult Mucus chest congestion 200 mg/10mL 51316-0743-08 CVS 1 bottle — — FDA listed —
Tussin 100 mg/5mL 53943-0507-26 Discount 237 ml — — FDA listed —
Childrens Chest Congestion Relief Grape 100 mg/5mL 53943-0511-24 Discount 118 ml — — FDA listed —
Llorens Care Tussin 100 mg/5mL 54859-0510-16 Llorens 473 ml — — FDA listed —
Guaifenesin 200 mg/10mL 55154-5780-05 Cardinal 5 cups — — FDA listed —
Guaifenesin 100 mg/5mL 55154-9450-05 Cardinal 5 cups — — FDA listed —
Geri-Tussin 200 mg/10mL 57896-0293-16 Geri-Care 473 ml — — FDA listed —
Geri-Tussin 100 mg/5mL 57896-0693-16 Geri-Care 473 ml — — FDA listed —
Cough Out 100 mg/5mL 58593-0255-04 Efficient 118 ml — — Discontinued —
Rompe Pecho SF 100 mg/5mL 58593-0265-04 Efficient 118 ml — — Discontinued —
Rompe Pecho EX 200 mg/10mL 58593-0829-04 Efficient 118 ml — — FDA listed —
Guaifenesin 100 mg/5mL 60687-0852-17 American 10 cups — — FDA listed —
Guaifenesin 200 mg/10mL 60687-0863-56 American 10 cups — — FDA listed —
Guaifenesin 300 mg/15mL 60687-0874-16 American 10 cups — — FDA listed —
Childrens Mucus Relief Chest Congestion 100 mg/5mL 63868-0770-04 Chain 1 bottle — — FDA listed —
SDA Laboratories Tussin 100 mg/5mL 66424-0563-16 SDA 473 ml — — FDA listed —
DRx Choice Fruit Punch 200 mg/10mL 68163-0743-04 Raritan 1 bottle — — FDA listed —
Adult Tussin 200 mg/10mL 69230-0332-23 Camber 1 bottle — — FDA listed —
Reliable-1 Tussin 100 mg/5mL 69618-0068-54 RELIABLE 118 ml — — FDA listed —
Akin 100 mg/5mL 69822-0200-02 Southern 118 ml — — FDA listed —
MAX Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 71399-0024-04 Akron 1 bottle — — FDA listed —
MAX Tussin Mucus and Chest Congestion 200 mg/10mL 71399-0054-08 Akron 1 bottle — — FDA listed —
Guaifenesin STRAWBERRY-BANANA FLAVOR 100 mg/5mL 71800-0059-19 Innovida 119 ml — — FDA listed —
Guaifenesin 100 mg/5mL 72162-2278-02 Bryant 473 ml — — FDA listed —
Guaifed 200 mg/10mL 73564-0801-04 Aldama 118 ml — — FDA listed —
Tussin Expectorant 100 mg/5mL 76281-0507-24 AptaPharma, 118 ml — — FDA listed —
Meijer Adult Mucus Plus chest congestion 200 mg/10mL 79481-7430-08 MEIJER 1 bottle — — FDA listed —
Guaifenesin 100 mg/5mL 81033-0102-51 KESIN 50 cups — — FDA listed —
Quality Choice Adult Tussin Expectorant 200 mg/10mL 83324-0332-04 QUALITY 1 bottle — — FDA listed —
Curewell Tussin 100 mg/5mL 85111-0693-16 RMT 473 ml — — 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
Oct 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.

🗺️ 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 00536-1314-85, 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
145.3K
Units reimbursed last 4 qtrs
35.6M
Gross reimbursed last 4 qtrs
$1.29M
Avg / prescription
$8.89
Avg / unit
$0.0363
Latest quarter Q4 2025
32.2KRx
Medicaid pays / mL
$0.0363
gross reimbursed
vs
NADAC / mL
$0.0112
acquisition cost
=
Spread
+$0.0251
+224% vs cost
What Medicaid paid per mL (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 ⓘ
67% FFS 33% MCO
Fee-for-service · 96,829 Rx Managed care · 48,517 Rx
State Medicaid map
Alaska: no data reported AK Maine: 134,379 units · 9,633 per 100k residents ME Washington: 1,722,666 units · 22,052 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 903,334 units · 15,746 per 100k residents MN Wisconsin: 956,630 units · 16,187 per 100k residents WI Michigan: 297,933 units · 2,968 per 100k residents MI New York: 10,121,829 units · 51,719 per 100k residents NY Vermont: 72,909 units · 11,269 per 100k residents VT New Hampshire: no data reported NH Oregon: 39,482 units · 933 per 100k residents OR Nevada: 310,644 units · 9,726 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 867,466 units · 6,913 per 100k residents IL Indiana: 1,574,569 units · 22,946 per 100k residents IN Ohio: 948,491 units · 8,048 per 100k residents OH Pennsylvania: 1,035,664 units · 7,991 per 100k residents PA New Jersey: 1,825,697 units · 19,652 per 100k residents NJ Massachusetts: no data reported MA California: 8,172,604 units · 20,974 per 100k residents CA Utah: 2,239 units · 65.5 per 100k residents UT Colorado: no data reported CO Nebraska: 342,283 units · 17,304 per 100k residents NE Missouri: 903,643 units · 14,584 per 100k residents MO Kentucky: 1,387,557 units · 30,657 per 100k residents KY West Virginia: no data reported WV Virginia: 382,068 units · 4,384 per 100k residents VA Maryland: 188,189 units · 3,045 per 100k residents MD Connecticut: 32,243 units · 891 per 100k residents CT Rhode Island: 186,805 units · 17,060 per 100k residents RI Arizona: 503,349 units · 6,774 per 100k residents AZ New Mexico: 29,301 units · 1,386 per 100k residents NM Kansas: no data reported KS Arkansas: 244,278 units · 7,965 per 100k residents AR Tennessee: 62,089 units · 871 per 100k residents TN North Carolina: no data reported NC South Carolina: 23,973 units · 446 per 100k residents SC Delaware: 157,513 units · 15,278 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 519,049 units · 17,655 per 100k residents MS Alabama: no data reported AL Georgia: 41,558 units · 377 per 100k residents GA D.C.: 26,218 units · 3,861 per 100k residents DC Hawaii: 107,854 units · 7,516 per 100k residents HI Texas: 1,476,476 units · 4,840 per 100k residents TX Florida: 1,411 units · 6.2 per 100k residents FL
Units reimbursed · per 100k residents
6.251,719
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 New York 51,719 /100k
2 Kentucky 30,657 /100k
3 Indiana 22,946 /100k
4 Washington 22,052 /100k
5 California 20,974 /100k
6 New Jersey 19,652 /100k
7 Mississippi 17,655 /100k
8 Nebraska 17,304 /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 Chest Congestion Relief (this brand).

Top reported reactions

Dyspnoea561
Pneumonia528
Nausea479
Fatigue450
Pain423
Diarrhoea402
Cough368

Age at onset

Neonate2
Infant2
Child20
Adolescent19
Adult530
Elderly535

Reporter sex

7,222 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization2,887
Death919
Life-threatening332
Disabling195
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 468 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
00536-1314-85 You're viewing this 473 mL in 1 BOTTLE (0536-1314-85) 2020-10-01 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses helps lossen phlegm (mucus) and thin bronchial secretions to make coughs more productive

⏱️ Dosage and Administration 39 words ▾

Directions Do not take more than 6 doses in a 24 hour period Do not exceed recommended dose Adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours children under 12 years ask a doctor

⚠️ Warnings 83 words ▾

Warnings Do not use if you ever had an allergic reaction to any of the indregients in this product Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

🧪 Active Ingredient 5 words ▾

Active ingredients Guaifenesin 100 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose

🎯 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 ↗
← 00536-1313-85 · RUGBY 00536-1315-43 · 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.