🆔 Identity & classification

FDA NDC (as labeled) 0904-6537-20

Product NDC 0904-6537

11-digit billing NDC 00904653720

NCPDP billing unit ML — per mL (volume)

RxCUI 1044949

UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ

UPC 0309046537205

Application # M012

SPL Set ID a9958b7d-7060-422b-a098-c1925c246081

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 2015-11-30

Route ORAL

Dosage form LIQUID

Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

GPI-14 43997303100908

GPI class Robafen CF Multi-Symptom Cold

GCN Seq No 000625

GCN 53090

HICL code 000216

Ingredient (HICL) Guaifen/Dextromethorphan/Pe

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 B4R

Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Decongestant-Expectorant

AHFS code 12:12.04.00

AHFS class Alpha-Adrenergic Agonists (12:12)

FDB label name ROBAFEN CF LIQUID

FDB brand name Robafen Cf

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

Why two NDCs? The FDA registers this code as 0904-6537-20 — 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 → 00904-6537-20. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist

Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives

How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor 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

LabelerMajor Pharmaceuticals

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code00904

First marketedNov 2015

Product typeHuman Otc Drug

Portfolio629 products on file

🔎 All NDCs from Major Pharmaceuticals

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 ROBAFEN CF LIQUID Ingredient Guaifen/Dextromethorphan/Pe

📖 About the active ingredient MedlinePlus · NLM

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

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗

🧪 What is this product?

Tussin Multi Symptom Cold CF Adult is an over-the-counter liquid taken by mouth that contains three active ingredients. Dextromethorphan is a cough suppressant commonly used to reduce coughing. Guaifenesin functions as an expectorant, typically used to help thin mucus so it is easier to cough up. Phenylephrine is a nasal decongestant often used to help relieve nasal congestion and stuffiness.

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.

🧪 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 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 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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 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 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.

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

The official label also statesanhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$0.021	$2.45 / 118 ml
Medicaid paysCMS SDUD · 12 mo	$0.0637	$7.52 / 118 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 28% 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 70000-0133-01	Cardinal	1 bottle	$0.018	—	FDA listed	save 14%
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 70677-1187-01	Strategic	1 bottle	$0.019	—	FDA listed	save 11%
Tussin Multi Symptom Cold CF Adult 20 mg/10mL; 200 mg/10mL; 10 mg/10mLthis 00904-6537-20	Major	1 bottle	$0.021	—	Availability likely	—
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 83324-0155-04	QUALITY	1 bottle	$0.021	—	Availability likely	—
Robitussin Peak Cold Multi-Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 00031-8742-14	Haleon	1 bottle	—	—	FDA listed	—
Bactimicina Cough And Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 24286-1546-04	DLC	1 bottle	—	—	FDA listed	—
Tukol Honey Children Cough and Congestion 5 mg/2.5mL; 50 mg/2.5mL; 2.5 mg/2.5mL 50066-0301-04	Genomma	1 bottle	—	—	FDA listed	—
Tukol Multi Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0504-24	Genomma	118 ml	—	—	FDA listed	—
Tukol Cough and Congestion 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0510-04	Genomma	1 bottle	—	—	FDA listed	—
Tukol X-Pecto Miel Multi Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0533-24	Genomma	118 ml	—	—	FDA listed	—
Tukol Cough And Cold Honey Flavor 100 mg/5mL; 5 mg/5mL; 10 mg/5mL 50066-0534-04	Genomma	1 bottle	—	—	FDA listed	—
GoodSense Tussin CF Multi-Symptom Cold, Raspberry 5 mg/5mL; 10 mg/5mL; 100 mg/5mL 50804-0256-04	Geiss,	118 ml	—	—	FDA listed	—
Desgen Dm 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 52083-0646-16	Kramer	474 ml	—	—	FDA listed	—
Mucosan Multi-Symptom Cherry 10 mg/5mL; 5 mg/5mL; 100 mg/5mL 53145-0693-04	Menper	1 bottle	—	—	FDA listed	—
Mucosan Multi-Symptom Honey 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53145-0695-04	Menper	1 bottle	—	—	FDA listed	—
Tussin CF Multi-Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53942-0504-26	DeMoulas	237 ml	—	—	FDA listed	—
Tussin CF 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53943-0504-26	Discount	237 ml	—	—	FDA listed	—
Multi-Symptom Cold 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 55319-0201-36	Family	1 bottle	—	—	FDA listed	—
Broncomiel Adults 200 mg/10mL; 10 mg/10mL; 20 mg/10mL 55758-0512-09	Pharmadel	1 bottle	—	—	FDA listed	—
Rompe Pecho CF 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 58593-0235-04	Efficient	118 ml	—	—	Discontinued	—
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 63941-0382-04	Best	1 bottle	—	—	FDA listed	—
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 63941-0823-04	Best	1 bottle	—	—	FDA listed	—
Tussin CF Non Drowsy Multi Symptom 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0266-18	WinCo	1 bottle	—	—	FDA listed	—
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0470-04	WinCo	1 bottle	—	—	FDA listed	—
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0691-04	WinCo	1 bottle	—	—	FDA listed	—
Tussin Cf 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 76281-0504-24	AptaPharma	118 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

🏛️

2015

On the market since

Nov 2015

📍

2026

Currently FDA-listed

11 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 00904-6537-20, 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

7K

Units reimbursed last 4 qtrs

1.3M

Gross reimbursed last 4 qtrs

$81K

Avg / prescription

$11.61

Avg / unit

$0.0637

Latest quarter Q4 2025

947Rx

Medicaid pays / mL

$0.0637

gross reimbursed

vs

NADAC / mL

$0.0208

acquisition cost

=

Spread

+$0.0429

+206% 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 ⓘ

78% FFS 22% MCO

Fee-for-service · 5,477 Rx Managed care · 1,505 Rx

State Medicaid map

Units reimbursed · per 100k residents

27.93,791

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 3,791 /100k

2 California 854 /100k

3 Texas 467 /100k

4 Hawaii 398 /100k

5 New Jersey 338 /100k

6 Indiana 73.2 /100k

7 Pennsylvania 33.1 /100k

8 Arizona 28.6 /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 Dextromethorphan HBr, Guaifenesin, Phenylephrine — the ingredient across all brands.

Top reported reactions

Fatigue51

Dyspnoea46

Cough44

Diarrhoea42

Nausea42

Pain35

Pneumonia35

Age at onset

Child1

Adult51

Elderly45

Reporter sex

Male · 37%

Female · 63%

Serious outcomes

Hospitalization185

Disabling12

Life-threatening10

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	Marketing start	Status
00904-6537-20 You're viewing this	1 BOTTLE, PLASTIC in 1 BOX (0904-6537-20) / 118 mL in 1 BOTTLE, PLASTIC	2015-11-30	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 31 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation

⏱️ Dosage and Administration 67 words ▾

Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age adult and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use

⚠️ Warnings 214 words ▾

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm ( mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product, do not use more than directed. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever 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 (1800-222-1222) right away.

📦 Storage and Handling 9 words ▾

Other information store between 20-25°C (68°-77°F). Do not refrigerate.

🧪 Active Ingredient 17 words ▾

Active ingredients (in each 10 mL) Dextromethorphan HBr 20 mg Guaifenesin 200 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

🎯 Purpose 6 words ▾

Purposes Cough suppressant Expectorant Nasal decongestant

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

🔗 Related NDC lookups

🧪 All Dextromethorphan Hbr, Guaifenesin, Phenylephrine NDCsSame ingredient 🏭 All Major labeler NDCsLabeler code 00904 📚 All Expectorant NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Non-Opioid Antitussive-Decongestant-Expectorant.

Guaifenesin/Dm/Pseudoephedrine 29978-0601-30

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine 20 mg/10mL; 200 mg/10mL; 10 mg/10mL Liquid

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class