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Guaifenesin 100 mg/5mL Liquid, 473 mL — NDC 58657-0508-16 package photo

Guaifenesin 100 mg/5mL Liquid, 473 mL

by Method Pharmaceuticals, LLC · 473 mL in 1 BOTTLE (58657-508-16)
NDC 58657-0508-16
🏷️ FDA NDC (as labeled) 58657-508-16 billing pads the product 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) 58657-508-16
Product NDC 58657-508
11-digit billing NDC 58657050816
NCPDP billing unit ML — per mL (volume)
RxCUI 310604
UNII 495W7451VQ
Application # M012
SPL Set ID 1539c3d4-d982-7d4e-e063-6394a90ad7d6
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 2024-04-01
Route ORAL
Dosage form LIQUID
Substance GUAIFENESIN
GPI-14 43200010000910
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 GUAIFENESIN 100 MG/5 ML SOLN
FDB brand name Guaifenesin
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 58657-508-16 — 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 → 58657-0508-16. 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

LabelerMethod Pharmaceuticals, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58657
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio78 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 GUAIFENESIN 100 MG/5 ML 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.

💊 What it looks like

Color red
FlavorCherry
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 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 T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

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

The official label also statesCaramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate

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 $0.0270 $12.77 / 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 2025 Feb 2026 May 2026 Aug 2026 $0.014 $0.011
▼ Down 15% over the last 9 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/5mL 00536-1314-85 RUGBY 473 ml $0.011 — Availability likely —
Guaifenesin 100 mg/5mLthis 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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 58657-0508-16, 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
62.2K
Units reimbursed last 4 qtrs
14.5M
Gross reimbursed last 4 qtrs
$391.9K
Avg / prescription
$6.30
Avg / unit
$0.0270
Latest quarter Q4 2025
17.2KRx
Medicaid pays / mL
$0.0270
gross reimbursed
vs
NADAC / mL
$0.0112
acquisition cost
=
Spread
+$0.0158
+141% 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 ⓘ
33% FFS 67% MCO
Fee-for-service · 20,554 Rx Managed care · 41,623 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 758,188 units · 9,705 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 315,944 units · 5,507 per 100k residents MN Wisconsin: 665,830 units · 11,266 per 100k residents WI Michigan: 333,491 units · 3,323 per 100k residents MI New York: 1,018,401 units · 5,204 per 100k residents NY Vermont: 43,163 units · 6,671 per 100k residents VT New Hampshire: no data reported NH Oregon: 79,753 units · 1,884 per 100k residents OR Nevada: 254,574 units · 7,970 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 542,746 units · 4,325 per 100k residents IL Indiana: 1,394,513 units · 20,322 per 100k residents IN Ohio: 989,141 units · 8,393 per 100k residents OH Pennsylvania: 925,196 units · 7,138 per 100k residents PA New Jersey: 871,932 units · 9,386 per 100k residents NJ Massachusetts: no data reported MA California: 1,075,272 units · 2,760 per 100k residents CA Utah: 5,210 units · 152 per 100k residents UT Colorado: no data reported CO Nebraska: 605,750 units · 30,624 per 100k residents NE Missouri: 336,641 units · 5,433 per 100k residents MO Kentucky: 778,497 units · 17,201 per 100k residents KY West Virginia: 147,628 units · 8,341 per 100k residents WV Virginia: 651,419 units · 7,474 per 100k residents VA Maryland: 394,976 units · 6,391 per 100k residents MD Connecticut: 41,652 units · 1,152 per 100k residents CT Rhode Island: 256,066 units · 23,385 per 100k residents RI Arizona: 490,617 units · 6,602 per 100k residents AZ New Mexico: 3,402 units · 161 per 100k residents NM Kansas: no data reported KS Arkansas: 175,350 units · 5,717 per 100k residents AR Tennessee: 32,375 units · 454 per 100k residents TN North Carolina: no data reported NC South Carolina: 80,771 units · 1,503 per 100k residents SC Delaware: 51,243 units · 4,970 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 437,315 units · 14,875 per 100k residents MS Alabama: no data reported AL Georgia: 346,881 units · 3,145 per 100k residents GA D.C.: 36,021 units · 5,305 per 100k residents DC Hawaii: 41,647 units · 2,902 per 100k residents HI Texas: 320,518 units · 1,051 per 100k residents TX Florida: 13,446 units · 59.5 per 100k residents FL
Units reimbursed · per 100k residents
59.530,624
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 Nebraska 30,624 /100k
2 Rhode Island 23,385 /100k
3 Indiana 20,322 /100k
4 Kentucky 17,201 /100k
5 Mississippi 14,875 /100k
6 Wisconsin 11,266 /100k
7 Washington 9,705 /100k
8 New Jersey 9,386 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58657-0508-16 You're viewing this 473 mL in 1 BOTTLE (58657-508-16) 2024-04-01 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 14 words ▾

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

⏱️ Dosage and Administration 62 words ▾

Directions do not take more than 6 doses in any 24-hour period age dose adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours children 2 to under 6 yars 1/2 to 1 teaspoonful every 4 hours children under 2 years ask a doctor

⚠️ Warnings 106 words ▾

Warnings 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 When using this product Do not use more than directed 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. If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 20 words ▾

Other information store at 20°-25°C (68°-77°F) packaged with tamper evident seal under cap each 5 mL contains: sodium 3 mg

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 5 mL) Guaifenesin 100 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate

🎯 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 ↗
← 58657-0505-08 · Method 58657-0509-16 · Method →
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.