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NeoTuss Plus Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl 4 mg/5mL; 30 mg/5mL; 7.5 mg/5mL Liquid, 30 mL — NDC 12539-0779-01 package photo

NeoTuss Plus Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl 4 mg/5mL; 30 mg/5mL; 7.5 mg/5mL Liquid, 30 mL

by DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals · 30 mL in 1 BOTTLE (12539-779-01)
NDC 12539-0779-01
🏷️ FDA NDC (as labeled) 12539-779-01 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes2 compare ↓
Also comes in: 474 ml 12539-0779-16
OTC On market Non-controlled
🗂️ Data synced Sep 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) 12539-779-01
Product NDC 12539-779
11-digit billing NDC 12539077901
RxCUI 2167750
UNII V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 2fabd782-14dc-1d1b-e063-6394a90af428
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Rece
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-28
Route ORAL
Dosage form LIQUID
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
GPI-14 43995803120918
GPI class NeoTuss Plus
GCN Seq No 062627
GCN 98401
HICL code 000375
Ingredient (HICL) Chlorpheniramine/Phenyleph/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 NEOTUSS PLUS LIQUID
FDB brand name Neotuss Plus
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 12539-779-01 — 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 → 12539-0779-01. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists
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

LabelerDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code12539
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio3 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 NEOTUSS PLUS LIQUID Ingredient Chlorpheniramine/Phenyleph/Dm
🧪 What is this product?

NeoTuss Plus is an over-the-counter oral liquid cough and cold medicine containing three active ingredients. Dextromethorphan is typically used to reduce cough, while chlorpheniramine is a first-generation antihistamine commonly used to help relieve allergy and cold symptoms like sneezing and runny nose. Phenylephrine is a nasal decongestant typically used to help ease nasal congestion. This product is marketed under FDA's over-the-counter monograph rules for cough and cold remedies.

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.

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.

💲 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: 474 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
NeoTuss Plus 4 mg/5mL; 30 mg/5mL; 7.5 mg/5mLthis 12539-0779-01 DORAL 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
12539-0779-16 474 mL in 1 BOTTLE (12539-779-16) 2025-03-06 Active
12539-0779-01 You're viewing this 30 mL in 1 BOTTLE (12539-779-01) 2025-02-28 Active

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

Pack size FAQ

What quantity is in NDC 12539-0779-01?
NDC 12539-0779-01 contains 30 mL — 30 ml in 1 bottle.
What is the difference between NDC 12539-0779-01 and NDC 12539-0779-16?
Both are NeoTuss Plus Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl 4 mg/5mL; 30 mg/5mL; 7.5 mg/5mL Liquid — the drug itself is identical. NDC 12539-0779-01 is the 30 mL package, while NDC 12539-0779-16 is the 474 ml package.
What NDC number is used to bill for this package of NeoTuss Plus Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl 4 mg/5mL; 30 mg/5mL; 7.5 mg/5mL Liquid?
Bill NDC 12539-0779-01 — the 11-digit billing format is 12539077901. 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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 12539-779-01, 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: 12539-0779-01, written without dashes as 12539077901. 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 12539-0779-01, the first segment (12539) is the labeler code FDA assigned to DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals; the middle segment (0779) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals. 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 474 ml (12539-0779-16). 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?
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals 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 and Cautions ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 116 words ▾

Adults and children over 12 years of age: One teaspoonful (5 mL) every 6-8 hours; do not exceed 4 teaspoonfuls in 24 hours period. Children 6-12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours; do not exceed 2 teaspoonfuls in 24 hours period. Children under 6 years of age: Ask a doctor.

Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus. Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies.

Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.

⏱️ Dosage and Administration 54 words ▾

Adults and children over 12 years of age: One teaspoonful (5 mL) every 6-8 hours; do not exceed 4 teaspoonfuls in 24 hours period. Children 6-12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours; do not exceed 2 teaspoonfuls in 24 hours period. Children under 6 years of age: Ask a doctor.

⚠️ Warnings and Cautions 36 words ▾

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.

⚠️ Warnings 36 words ▾

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.

🧪 Active Ingredient 21 words ▾

Dextromethorphan HBr 30 mg / 5 mL Chlorpheniramine Maleate 4 mg / 5 mL Phenylephrine HCl 7.5 mg / 5 mL

🧪 Inactive Ingredients 18 words ▾

Artificial and natural flavors, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sorbitol, and sucralose.

🎯 Purpose 66 words ▾

Antitussive, Antihistamine, and Decongestant. Temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold or inhaled irritants. Helps thin bronchial passageways of bothersome mucus.

Temporarily relieves nasal congestion due to the common cold, sinusitis, hay fever or other respiratory allergies. Temporarily relieves sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 12539-0555-16 · DORAL 12543-3209-02 · Meiji →
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.