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Guaifenesin 100 mg/5mL Liquid, 473 mL — NDC 58657-0509-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guaifenesin 100 mg/5mL Liquid, 473 mL — NDC 58657-509-16 (Billing 58657-0509-16)

by Method Pharmaceuticals, LLC · 473 mL in 1 BOTTLE

This is a package of 473 mL of Guaifenesin 100 mg/5mL Liquid from Method Pharmaceuticals, LLC, marketed since Feb 2016 and currently FDA-listed; retail pharmacies pay about $0.0133 per mL (NADAC). It is this product's only package size.

NDC 58657-0509-16
🏷️ FDA NDC (as labeled) 58657-509-16 billing pads the product 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) 58657-509-16
Product NDC 58657-509
11-digit billing NDC 58657050916
NCPDP billing unit ML — per mL (volume)
RxCUI 310604
UNII 495W7451VQ
Application # M012
SPL Set ID 312ce620-4841-7488-e054-00144ff88e88
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 2016-02-09
Route ORAL
Dosage form LIQUID
Substance GUAIFENESIN

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

GPI-14 43200010000910
GPI class guaiFENesin
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 LIQUID
FDB brand name Guaifenesin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 022210
  • GCN: 02512
  • GPI-14 (Medi-Span): 43200010000910
  • HICL (First Databank): 000271
  • AHFS class code: 48:16.00.00
  • RxCUI (RxNorm): 310604
Why two NDCs? The FDA registers this code as 58657-509-16 — 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 → 58657-0509-16. 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.

Clinical

Label name GUAIFENESIN 100 MG/5 ML LIQUID Ingredient Guaifenesin
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin doesn't suppress your cough — it actually makes it work better. It loosens and thins the mucus in your chest so your cough can move it out of your airways more effectiv...
  • What exactly does guaifenesin do — does it actually stop my cough?
  • No — extended-release tablets like 12 Hour Mucus Relief and 365 Whole Foods Market Guaifenesin must be swallowed whole. Crushing, chewing, or breaking them releases the medicine al...
  • Can I crush or split the extended-release tablet to make it easier to swallow?
📖 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.

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 $0.013 $6.29 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0469 $22.18 / 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 May 2022 Nov 2022 Jan 2026 $0.014 $0.009
▲ Up 14% over the last 16 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58657-0509-16 You're viewing this Main listing 473 mL in 1 BOTTLE 2016-02-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chest Congestion Relief 100 mg/5mL 00536-1314-85 RUGBY 473 ml $0.011 — Availability likely save 17%
Guaifenesin 100 mg/5mL 58657-0508-16 Method 473 ml $0.011 — Availability likely save 17%
Guaifenesin 100 mg/5mL 83720-0503-16 Oncor 473 ml $0.011 — Availability likely save 17%
Guaifenesin 100 mg/5mLthis 58657-0509-16 Method 473 ml $0.013 — FDA listed —
Good Neighbor Adult Tussin Mucus and chest congestion 200 mg/10mL 46122-0785-29 AMERISOURCE 1 bottle $0.023 — Availability likely +72%
Tusnel EX 100 mg/5mL 54859-0507-04 Llorens 118 ml $0.023 — Availability likely +72%
Mucolyte 100 mg/5mL 57237-0359-12 Rising 118 ml $0.023 — Availability likely +72%
Tussin 200 mg/10mL 70677-1186-01 Strategic 1 bottle $0.023 — Availability likely +72%
Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 82568-0012-04 AARNA 1 bottle $0.023 — Availability likely +72%
QCH Adult Tussin 541 200 mg/10mL 83324-0024-04 Chain 1 bottle $0.023 — Availability likely +72%
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor 400 mg/20mL 63824-0537-66 Reckitt 180 ml $0.061 — FDA listed +355%
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

🏛️
2016
On the market since
Feb 2016
📍
2026
Currently FDA-listed
10 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerMethod Pharmaceuticals, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58657
First marketedFeb 2016
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.

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 66 words ▾

Directions do not take more than 6 doses in any 24-hour period age dose adults and children 2 to 4 teaspoonfuls 12 years and over every 4 hours children 6 years to 1 to 2 teaspoonfuls under 12 years every 4 hours children 2 years to ½ to 1 teaspoonful under 6 years every 4 hours children under 2 years ask a doctor Drug Facts (continued)

⚠️ Warnings 96 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 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 13 words ▾

Other information store at 20°-25°C (68°-77°F) packaged with tamper evident seal under cap

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 5 mL) Guaifenesin 100 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

🎯 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 ↗

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 this package alone, 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
19.5K
Units reimbursed last 4 qtrs
4.5M
Gross reimbursed last 4 qtrs
$212.8K
Avg / prescription
$10.93
Avg / unit
$0.0469
Latest quarter Q4 2025
3.9KRx
Medicaid pays / mL
$0.0469
gross reimbursed
vs
NADAC / mL
$0.0133
acquisition cost
=
Spread
+$0.0336
+253% 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 ⓘ
70% FFS 30% MCO
Fee-for-service · 13,585 Rx Managed care · 5,895 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 117,378 units · 1,503 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 91,382 units · 1,593 per 100k residents MN Wisconsin: 48,147 units · 815 per 100k residents WI Michigan: 49,795 units · 496 per 100k residents MI New York: 2,345,822 units · 11,986 per 100k residents NY Vermont: 2,970 units · 459 per 100k residents VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 37,166 units · 1,164 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 71,482 units · 570 per 100k residents IL Indiana: 20,374 units · 297 per 100k residents IN Ohio: 84,892 units · 720 per 100k residents OH Pennsylvania: 349,886 units · 2,700 per 100k residents PA New Jersey: 29,771 units · 320 per 100k residents NJ Massachusetts: no data reported MA California: 165,499 units · 425 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 161,191 units · 8,149 per 100k residents NE Missouri: 59,380 units · 958 per 100k residents MO Kentucky: 123,229 units · 2,723 per 100k residents KY West Virginia: 108,549 units · 6,133 per 100k residents WV Virginia: 92,007 units · 1,056 per 100k residents VA Maryland: 52,896 units · 856 per 100k residents MD Connecticut: 3,349 units · 92.6 per 100k residents CT Rhode Island: 118,294 units · 10,803 per 100k residents RI Arizona: 28,444 units · 383 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 21,258 units · 693 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 2,752 units · 51.2 per 100k residents SC Delaware: 11,315 units · 1,097 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 290,650 units · 9,886 per 100k residents MS Alabama: no data reported AL Georgia: 51,648 units · 468 per 100k residents GA D.C.: 3,110 units · 458 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
51.211,986
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 11,986 /100k
2 Rhode Island 10,803 /100k
3 Mississippi 9,886 /100k
4 Nebraska 8,149 /100k
5 West Virginia 6,133 /100k
6 Kentucky 2,723 /100k
7 Pennsylvania 2,700 /100k
8 Minnesota 1,593 /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.
← 58657-0508-16 · Method 58657-0518-08 · 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.