NDC 00485-0204-16 — Rynex DM Brompheniramine Maleate

🆔 Identity & classification

FDA NDC (as labeled) 0485-0204-16

Product NDC 0485-0204

11-digit billing NDC 00485020416

NCPDP billing unit ML — per mL (volume)

RxCUI 1090463

UNII 04JA59TNSJ, IXA7C9ZN03, 9D2RTI9KYH

Application # M012

SPL Set ID 7be2c282-24ba-4f19-9b14-872d3f5746a7

Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist

Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2011-03-14

Route ORAL

Dosage form LIQUID

Substance PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE

GPI-14 43995803080910

GPI class Rynex DM

GCN Seq No 060622

GCN 26808

HICL code 035368

Ingredient (HICL) Brompheniram/Phenylephrine/Dm

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 B3R

Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest

AHFS code 04:04.20.00

AHFS class Propylamine Derivatives

FDB label name RYNEX DM LIQUID

FDB brand name Rynex Dm

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

Why two NDCs? The FDA registers this code as 0485-0204-16 — 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 → 00485-0204-16. 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 Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines

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

LabelerEdwards Pharmaceuticals, Inc

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code00485

First marketedMar 2011

Product typeHuman Otc Drug

🔎 All NDCs from Edwards Pharmaceuticals, Inc

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 RYNEX DM LIQUID Ingredient Brompheniram/Phenylephrine/Dm

🧪 What is this product?

Rynex DM is an oral liquid cold and cough product sold over the counter under FDA's OTC monograph rules. It contains three active ingredients commonly used to relieve symptoms associated with the common cold and upper respiratory conditions. Brompheniramine maleate functions as an antihistamine typically used to reduce sneezing and runny nose. Dextromethorphan hydrobromide is a cough suppressant, and phenylephrine hydrochloride is a nasal decongestant, both commonly included in products meant to ease respiratory discomfort.

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

FlavorTutti Frutti

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 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 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 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.

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

The official label also statesCitric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

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	$0.051	$24.31 / 473 ml
Medicaid paysCMS SDUD · 12 mo	$0.0824	$38.98 / 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

▲ Up 37% over the last 19 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
Cold and Cough Relief children 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 70677-0121-01	Strategic	1 bottle	$0.017	—	Discontinued	save 67%
Rynex DM 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mLthis 00485-0204-16	Edwards	473 ml	$0.051	—	Availability likely	—
EndaCof DM 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 68047-0143-16	Larken	473 ml	$0.051	—	Availability likely	—
Good Sense Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 00113-0987-26	L.	1 bottle	$0.075	—	Availability likely	+46%
dimaphen dm 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 00904-6463-20	Major	1 bottle	$0.075	—	Availability likely	+46%
good neighbor pharmacy cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 24385-0519-26	Amerisource	1 bottle	$0.075	—	Availability likely	+46%
Signature Care Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 21130-0082-26	Safeway	1 bottle	—	—	Discontinued	—
Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 30142-0987-26	Kroger	1 bottle	—	—	FDA listed	—
cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 37808-0987-26	H	1 bottle	—	—	FDA listed	—
equaline childrens cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 41163-0987-26	United	1 bottle	—	—	FDA listed	—
CareOne Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 41520-0987-26	American	1 bottle	—	—	Discontinued	—
equate childrens cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 49035-0082-34	Wal-Mart	1 bottle	—	—	FDA listed	—
Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 51316-0578-03	CVS	1 bottle	—	—	FDA listed	—
Childrens Dimetapp Cold And Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 51316-0645-08	CVS	1 bottle	—	—	FDA listed	—
Pediacare Childrens Cough and Cold Grape 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 52412-0920-01	RANDOB	1 bottle	—	—	FDA listed	—
Childrens Metapp Daytime 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 53041-0577-03	Guardian	1 bottle	—	—	FDA listed	—
Cold and Cough DM 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 56062-0987-26	Publix	1 bottle	—	—	FDA listed	—
dimaphen dm 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 68788-8134-01	Preferred	1 bottle	—	—	FDA listed	—
Good Sense Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 68788-8331-01	Preferred	1 bottle	—	—	FDA listed	—
Dimetapp Cold and Cough 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 80070-0310-04	Foundation	1 bottle	—	—	FDA listed	—
TARGET CHILDRENs COLD and COUGH 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 82442-0645-04	TARGET	1 bottle	—	—	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

🏛️

2011

On the market since

Mar 2011

📍

2026

Currently FDA-listed

15 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 00485-0204-16, 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

40.6K

Units reimbursed last 4 qtrs

8.2M

Gross reimbursed last 4 qtrs

$675.2K

Avg / prescription

$16.64

Avg / unit

$0.0824

Latest quarter Q4 2025

11.1KRx

Medicaid pays / mL

$0.0824

gross reimbursed

vs

NADAC / mL

$0.0514

acquisition cost

=

Spread

+$0.0310

+60% 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 ⓘ

14% FFS 86% MCO

Fee-for-service · 5,682 Rx Managed care · 34,896 Rx

State Medicaid map

Units reimbursed · per 100k residents

279235,566

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 Mississippi 235,566 /100k

2 New Jersey 2,664 /100k

3 New York 1,734 /100k

4 Georgia 1,399 /100k

5 California 1,052 /100k

6 Kentucky 570 /100k

7 New Mexico 347 /100k

8 Texas 279 /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 ml this page00485-0204-16 40,578 Rx · $675,192

118 ml00485-0204-04 8,289 Rx · $117,164

Drug total (last 4 qtrs): 48,867 Rx · 9,671,079 units · $792,357 gross reimbursed

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

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00485-0204-04	118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)	$0.0750 / mL	$8.85	2011-03-14	Active
00485-0204-16 You're viewing this	473 mL in 1 BOTTLE (0485-0204-16)	$0.0514 / mL	$24.32	2011-03-14	Active

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

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0514 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 83% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00485-0204-16?

NDC 00485-0204-16 contains 473 mL — 473 ml in 1 bottle.

What is the difference between NDC 00485-0204-16 and NDC 00485-0204-04?

Both are Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid — the drug itself is identical. NDC 00485-0204-16 is the 473 mL package, while NDC 00485-0204-04 is the 118 ml package. Per-mL NADAC also differs: $0.0514 here vs $0.0750 for the 118 ml pack.

What NDC number is used to bill for this package of Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid?

Bill NDC 00485-0204-16 — the 11-digit billing format is 00485020416. 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 45 words ▾

Uses temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 62 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and older: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours. Children under 6 years of age: Consult a doctor

⚠️ Warnings ~1 min read ▾

Warnings Do not exceed recommended dosage. Do not use this product 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 a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating to to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

A persistent cough may be a sign of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 10 words ▾

Other information Store at 59° - 86°F (15° - 30°C)

🧪 Active Ingredient 20 words ▾

Drug Facts Active ingredients (in each 5 mL teaspoonful) Brompheniramine Maleate 1mg Dextromethorphan Hydrobromide 5 mg Phenylephrine Hydrochloride 2.5 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

🎯 Purpose 5 words ▾

Purpose Antihistamine Antitussive 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 Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride NDCsSame ingredient 🏭 All Edwards labeler NDCsLabeler code 00485 📚 All Sigma-1 Agonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Non-Opioid Antitus-1St Gen.antihistamine-Decongest.

Brompheniramine/Pseudoephed/Dm 00121-0933-04 Chlorpheniramine/Phenyleph/Dm 00485-0171-16 Pheniramine/Phenylephrine/Dm 50991-0444-15 Chlorpheniramin/Pseudoephed/Dm 64543-0105-04

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.

Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL Liquid, 473 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

📦 Packaging — all sizes for this product

Pack size FAQ

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class