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BRONCOCHEM MAXIMUM COUGH NIGHT DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE 30 mg/5mL; 50 mg/5mL Syrup — NDC 65131-0110-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BRONCOCHEM MAXIMUM COUGH NIGHT DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE 30 mg/5mL; 50 mg/5mL Syrup — NDC 65131-110-35 (Billing 65131-0110-35)

by LABORATORIO MAGNACHEM INTERNATIONAL SRL · 1 BOTTLE, PLASTIC in 1 BOX / 120 mL in 1 BOTTLE, PLASTIC

This is a package of BRONCOCHEM MAXIMUM COUGH NIGHT DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE 30 mg/5mL; 50 mg/5mL Syrup from LABORATORIO MAGNACHEM INTERNATIONAL SRL, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 65131-0110-35
🏷️ FDA NDC (as labeled) 65131-110-35 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 65131-110-35 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65131 labeler · 110 product · 35 package
Package marketed since
Apr 21, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0805418103585
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65131-110-35
Product NDC 65131-110
11-digit billing NDC 65131011035
RxCUI 2712157
UNII 9D2RTI9KYH, R35D29L3ZA
UPC 0805418103585
Application # M
SPL Set ID dffdfa2c-a52e-4606-9b07-c8993e499f09
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action 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 2025-04-21
Route ORAL
Dosage form SYRUP
Substance DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Quick answers
  • RxCUI (RxNorm): 2712157
Why two NDCs? The FDA registers this code as 65131-110-35 — 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 → 65131-0110-35. 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.

Clinical

🧪 What is this product?

Broncochem Maximum Cough Night is an over-the-counter oral syrup marketed under FDA's OTC monograph rules. It contains dextromethorphan hydrobromide, a cough suppressant commonly used to reduce cough reflex, and pyrilamine maleate, a first-generation antihistamine typically used for its sedating properties and to help with nighttime symptoms. This combination product is formulated for nighttime use when cough and related symptoms may interfere with sleep.

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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65131-0110-35 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOX / 120 mL in 1 BOTTLE, PLASTIC 2025-04-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Broncochem Maximum Cough Night 30 mg/5mL; 50 mg/5mLthis 65131-0110-35 LABORATORIO 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

🏛️
2025
On the market since
Apr 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.

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.

  • 0.25 mL / 5 mL UNII 7528N5H79B
    A liquid solvent derived from grain fermentation. In medicines, it dissolves active ingredients, helps preserve the product, and improves how the body absorbs the drug.
  • 0.25 mg / 5 mL UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 5 mg / 5 mL UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • 0.833 mg / 5 mL UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • 1.5 mg / 5 mL UNII 625NNB0G9N
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps keep the product safe and stable throughout its shelf life.
  • 10 mg / 5 mL 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.
  • 0.083 mL / 5 mL UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 2.65 mg / 5 mL UNII 81H2R5AOH3
    A natural sweetener and carbohydrate derived from sugarcane plants. In medicines, it sweetens the taste to improve palatability and may serve as a bulking agent or binder in tablets and powders.
  • 5 mL / 5 mL 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.

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

The official label also statesSugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

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.

Manufacturer & labeler

LabelerLABORATORIO MAGNACHEM INTERNATIONAL SRL
FDA applicationM (OTC MONOGRAPH DRUG)
Labeler code65131
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from LABORATORIO MAGNACHEM INTERNATIONAL SRL labeler code 65131

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.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

⏱️ Dosage and Administration 39 words ▾

Dosage and Administration Do not exceed 4 doses in a 24 hour period. Adult and children 12 years and older: 10 mL 3-4 times a day. Children 6 to under 12 years old: 5 mL 3-4 times a day.

⚠️ Warnings 47 words ▾

Warnings The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately. Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping.

🧪 Active Ingredient 9 words ▾

OTC - Active Ingredient Section Dextromethorphan HBr Mepyramine maleate

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredient Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

🎯 Purpose 4 words ▾

OTC-PURPOSE SECTION Antitussive Antihistamine

📄 Do Not Use 86 words ▾

Do Not Use Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee. If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them). If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.

📄 Ask a Doctor or Pharmacist Before Use If 50 words ▾

Ask a doctor/pharmacist Ask a doctor before use if yoy have Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash. If pregnant or breast-feeding ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep Out of the Reach of Children In case of accidental overdose, seek professional help or go to poison control center immediately.

📄 Package Label / Principal Display Panel 16 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Broncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL BroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpg

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

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) ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 LABORATORIO MAGNACHEM INTERNATIONAL SRL. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LABORATORIO MAGNACHEM INTERNATIONAL SRL 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.
← 65131-0109-84 · LABORATORIO 65131-0111-21 · LABORATORIO →
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.