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M-END DMX Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride .667 mg/5mL; 10 mg/5mL; 20 mg/5mL Liquid, 30 mL

by R. A. McNeil Company · 30 mL in 1 BOTTLE (12830-816-30)
NDC 12830-0816-30
🏷️ FDA NDC (as labeled) 12830-816-30 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes2 compare ↓
Also comes in: 473 ml 12830-0816-16
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) 12830-816-30
Product NDC 12830-816
11-digit billing NDC 12830081630
RxCUI 1190600
UNII BPA9UT29BS, 9D2RTI9KYH, 6V9V2RYJ8N
Application # M012
SPL Set ID ee1fae2e-3a21-4487-9989-c7620a4a7056
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-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 2011-10-13
Route ORAL
Dosage form LIQUID
Substance DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
GPI-14 43995803480930
GPI class M-End DMX
GCN Seq No 068103
GCN 30801
HICL code 038161
Ingredient (HICL) Dexbromphen/Pseudoephedrine/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 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name M-END DMX LIQUID
FDB brand name M-End Dmx
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 12830-816-30 — 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 → 12830-0816-30. 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

LabelerR. A. McNeil Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code12830
First marketedOct 2011
Product typeHuman Otc Drug
Portfolio2 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 M-END DMX LIQUID Ingredient Dexbromphen/Pseudoephedrine/Dm
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Brompheniramine is used to treat allergy and cold symptoms: sneezing runny nose itching of the nose or throat red, itchy, watery eyes Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
🧪 What is this product?

M-END DMX is an over-the-counter liquid medication taken by mouth that contains three active ingredients commonly used in multi-symptom cold products. Dextromethorphan is typically used to suppress cough, while pseudoephedrine is commonly used to relieve nasal congestion. Dexbrompheniramine maleate is an antihistamine typically used to reduce sneezing, runny nose, and other allergy-like symptoms. This product is marketed under the FDA's over-the-counter monograph rules for cold and cough medications.

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 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 statesBitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 473 ml
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
M-End Dmx .667 mg/5mL; 10 mg/5mL; 20 mg/5mLthis 12830-0816-30 R. 30 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

🏛️
2011
On the market since
Oct 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.

🔬 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 Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Abdominal Pain1
Abdominal Pain Lower1
Abdominal Pain Upper1
Adenoidal Hypertrophy1
Anxiety1
Arthralgia1
Attention Deficit/hyperactivity Disorder1

Reporter sex

4 reports
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 NDCDescription Marketing startStatus
12830-0816-16 473 mL in 1 BOTTLE (12830-816-16) 2011-10-13 Active
12830-0816-30 You're viewing this 30 mL in 1 BOTTLE (12830-816-30) 2011-10-13 Active

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

Pack size FAQ

What quantity is in NDC 12830-0816-30?
NDC 12830-0816-30 contains 30 mL — 30 ml in 1 bottle.
What is the difference between NDC 12830-0816-30 and NDC 12830-0816-16?
Both are M-END DMX Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride .667 mg/5mL; 10 mg/5mL; 20 mg/5mL Liquid — the drug itself is identical. NDC 12830-0816-30 is the 30 mL package, while NDC 12830-0816-16 is the 473 ml package.
What NDC number is used to bill for this package of M-END DMX Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride .667 mg/5mL; 10 mg/5mL; 20 mg/5mL Liquid?
Bill NDC 12830-0816-30 — the 11-digit billing format is 12830081630. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 12830-816-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 12830-0816-30, written without dashes as 12830081630. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 12830-0816-30, the first segment (12830) is the labeler code FDA assigned to R. A. McNeil Company; the middle segment (0816) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by R. A. McNeil Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 473 ml (12830-0816-16). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
R. A. McNeil Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 46 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 the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 68 words ▾

Directions Do not exceed 4 doses in a 24 hour period. Adults and children 12 years of age and over: 3 teaspoonfuls (15 mL) every 6 hours, not to exceed 12 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 1 1/2 teaspoonfuls (7.5 mL) every 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children under 6 years of age: Consult a Physician.

⚠️ 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 due 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 tranquilizes may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if 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. nervousness, dizziness, or sleeplessness occur new symptoms occur 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 6 words ▾

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

🧪 Active Ingredient 28 words ▾

Drug Facts Active ingredients (in each 5 mL teaspoonful) Dexbrompheniramine Maleate 0.667 mg Dextromethorphan HBr 10 mg Pseudeophedrine HCl 20 mg Purpose Antihistamine Antitussive Cough Suppressant Nasal Decongestant

🧪 Inactive Ingredients 20 words ▾

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

🎯 Purpose 7 words ▾

Purpose Antihistamine Antitussive Cough Suppressant Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 12830-0762-15 · R.A. 12830-0864-04 · R. →
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.