NDC 58657-0500-04 — Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL

🆔 Identity & classification

FDA NDC (as labeled) 58657-500-04

Product NDC 58657-500

11-digit billing NDC 58657050004

NCPDP billing unit ML — per mL (volume)

RxCUI 995868

UNII GSL05Y1MN6, 495W7451VQ

Application # M012

SPL Set ID fe126254-6ee6-48c3-965c-96e4276a5314

Established class (EPC) Expectorant

Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions

DEA schedule CV

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2014-04-01

Route ORAL

Dosage form SOLUTION

Substance CODEINE PHOSPHATE; GUAIFENESIN

GPI-14 43997002282020

GPI class guaiFENesin-Codeine

GCN Seq No 045669

GCN 91713

HICL code 000206

Ingredient (HICL) Codeine Phosphate/Guaifenesin

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 B4S

Therapeutic class — specific (HIC3) Opioid Antitussive-Expectorant Combination

AHFS code 28:08.08.00

AHFS class Opioid Agonists (28:08)

FDB label name CODEINE-GUAIFEN 10-100 MG/5 ML

FDB brand name Codeine-Guaifenesin

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 58657-500-04 — 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 → 58657-0500-04. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist

Drug family (ATC) Opium alkaloids and derivatives

How it works Full Opioid Agonists

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 2014

DEA scheduleCV

Product typeHuman Otc Drug

Portfolio78 products on file

🔎 All NDCs from Method Pharmaceuticals, LLC

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 CODEINE-GUAIFEN 10-100 MG/5 ML Ingredient Codeine Phosphate/Guaifenesin

📖 About the active ingredient: Codeine Phosphate; Guaifenesin MedlinePlus · NLM

General information about the ingredient itself — the description of this specific product follows below.

Codeine is used to relieve pain. It is also used to relieve cough. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen and aspirin, and as an ingredient in many cough and cold medications. This monograph only includes informatio...

Read the full MedlinePlus article ↗

🧪 What is this product?

This is an oral solution containing codeine phosphate and guaifenesin, marketed as an over-the-counter monograph product. Codeine is a cough suppressant typically used to reduce cough reflex, while guaifenesin functions as an expectorant commonly used to help thin and clear mucus from the airways. Products combining these ingredients are typically used for temporary relief of cough and congestion associated with minor respiratory conditions.

Patient education

📘 MedlinePlus patient leaflet ↗

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

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 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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 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 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 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 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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.

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

The official label also statesCherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$0.059	$7.06 / 120 ml
Medicaid paysCMS SDUD · 12 mo	$0.1319	$15.83 / 120 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

▲ Up 17% 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mLthis 58657-0500-04	Method	120 ml	$0.059	—	Availability likely	—
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 00121-0775-04	PAI	118 ml	$0.064	—	Availability likely	+10%
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 69367-0272-04	Westminster	118 ml	$0.064	—	Availability likely	+10%
Guaifenesin and Codeine Phosphate 200 mg/10mL; 20 mg/10mL 00121-1550-00	PAI	10 cups	—	—	FDA listed	—
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 00121-1775-00	PAI	10 cups	—	—	FDA listed	—
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 50090-1428-00	A-S	118 ml	—	—	FDA listed	—
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 50090-6435-00	A-S	118 ml	—	—	FDA listed	—
Guaifenesin and Codeine Phosphate 10 mg/5mL; 100 mg/5mL 55154-5791-05	Cardinal	5 cups	—	—	FDA listed	—
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 68071-5173-04	NuCare	120 ml	—	—	FDA listed	—
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 68788-8361-01	Preferred	118 ml	—	—	FDA listed	—
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 71205-0624-04	Proficient	118 ml	—	—	FDA listed	—
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 72162-1669-02	Bryant	120 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

🏛️

2014

On the market since

Apr 2014

📍

2026

Currently FDA-listed

12 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 58657-0500-04, 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 – Q1 2026 · 5 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

1.8K

Units reimbursed last 4 qtrs

231.8K

Gross reimbursed last 4 qtrs

$30.6K

Avg / prescription

$16.77

Avg / unit

$0.1319

Latest quarter Q1 2026

65Rx

Medicaid pays / mL

$0.1319

gross reimbursed

vs

NADAC / mL

$0.0588

acquisition cost

=

Spread

+$0.0731

+124% 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 ⓘ

89% FFS

Fee-for-service · 1,631 Rx Managed care · 192 Rx

State Medicaid map

Units reimbursed · per 100k residents

14.2511

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 511 /100k

2 Oregon 261 /100k

3 Wisconsin 141 /100k

4 Hawaii 114 /100k

5 Maryland 46.3 /100k

6 Kentucky 44.4 /100k

7 Virginia 38.3 /100k

8 Minnesota 28.5 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

473 ml58657-0500-16 3,095 Rx · $41,049

120 ml this page58657-0500-04 1,823 Rx · $30,563

Drug total (last 4 qtrs): 4,918 Rx · 727,997 units · $71,612 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Codeine-Guaifenesin (this brand).

Top reported reactions

Death11

Fatigue11

Nausea11

Pain11

Pneumonia10

Vomiting9

Pyrexia8

Reporter sex

Serious outcomes

Death17

Life-threatening6

Disabling5

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Per unit	Per pack	Marketing start	Status
58657-0500-04 You're viewing this	120 mL in 1 BOTTLE (58657-500-04)	$0.0588 / mL	$7.05	2014-04-01	Active
58657-0500-16	473 mL in 1 BOTTLE (58657-500-16)	$0.0327 / mL	$15.47	2014-04-01	Active

You're viewing the smallest of 2 pack sizes for this product.

Per mL, this pack runs about 80% above the cheapest pack (473 mL, $0.0327 vs $0.0588 NADAC).

This pack accounts for about 37% of this product's recent Medicaid fills; most go to the 473 ml pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 58657-0500-04?

NDC 58657-0500-04 contains 120 mL — 120 ml in 1 bottle.

What is the difference between NDC 58657-0500-04 and NDC 58657-0500-16?

Both are Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL Solution — the drug itself is identical. NDC 58657-0500-04 is the 120 mL package, while NDC 58657-0500-16 is the 473 ml package. Per-mL NADAC also differs: $0.0588 here vs $0.0327 for the 473 ml pack.

What NDC number is used to bill for this package of Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL Solution?

Bill NDC 58657-0500-04 — the 11-digit billing format is 58657050004. 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 47 words ▾

Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.

⏱️ Dosage and Administration 61 words ▾

Directions do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

⚠️ Warnings 180 words ▾

Warnings Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache.

These may be symptoms 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 9 words ▾

Other information Store at controlled room temperature 15°-30°C (59°-86°F).

🧪 Active Ingredient 23 words ▾

Active ingredient (in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg

Active ingredient (in each teaspoonful (5 mL)) Guaifenesin USP 100 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

🎯 Purpose 4 words ▾

Purpose Antitussive

Purpose Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Codeine Phosphate And Guaifenesin NDCsSame ingredient 🏭 All Method labeler NDCsLabeler code 58657 📚 All Expectorant NDCsDrug class

Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL Solution, 120 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

💊 Medicaid utilization by pack size

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups