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BRONCOCHEM EXPECTORANT II ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl 250 mg/10mL; 4 mg/10mL; 13.33 mg/10mL; 200 mg/10mL; 5 mg/10mL Syrup — NDC 65131-0116-87 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BRONCOCHEM EXPECTORANT II ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl 250 mg/10mL; 4 mg/10mL; 13.33 mg/10mL; 200 mg/10mL; 5 mg/10mL Syrup — NDC 65131-116-87 (Billing 65131-0116-87)

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

This is a package of BRONCOCHEM EXPECTORANT II ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl 250 mg/10mL; 4 mg/10mL; 13.33 mg/10mL; 200 mg/10mL; 5 mg/10mL Syrup from LABORATORIO MAGNACHEM INTERNATIONAL SRL, marketed since Dec 2016 and currently FDA-listed. It is this product's only package size.

NDC 65131-0116-87
🏷️ FDA NDC (as labeled) 65131-116-87 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 Oct 1, 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 65131-116-87 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65131 labeler · 116 product · 87 package
Package marketed since
Dec 30, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0805418116875
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65131-116-87
Product NDC 65131-116
11-digit billing NDC 65131011687
RxCUI 1743369
UNII 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0805418116875
Application # part343
SPL Set ID d0426469-9dd1-4bd1-b81e-69d33187daa2
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-12-30
Route ORAL
Dosage form SYRUP
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1743369
Why two NDCs? The FDA registers this code as 65131-116-87 — 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 → 65131-0116-87. 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 Anilides class.

Drug family (ATC) Anilides
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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

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

Broncochem Expectorant II is an oral syrup marketed as an over-the-counter cough and cold medicine under FDA monograph rules. It contains acetaminophen, typically used to reduce fever and relieve pain; chlorpheniramine maleate, an antihistamine commonly used to ease allergy symptoms and congestion; dextromethorphan, typically used as a cough suppressant; guaifenesin, an expectorant commonly used to thin mucus and ease congestion; and phenylephrine, a decongestant typically used to relieve nasal and sinus congestion. The combination is intended for oral use in managing multiple cold and cough symptoms at once.

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
65131-0116-87 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOX / 120 mL in 1 BOTTLE, PLASTIC 2016-12-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Broncochem Expectorant Ii 250 mg/10mL; 4 mg/10mL; 13.33 mg/10mL; 200 mg/10mL; 5 mg/10mLthis 65131-0116-87 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

🏛️
2016
On the market since
Dec 2016
📍
2026
Currently FDA-listed
10 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.

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.

  • 0.016 mL / 10 mL UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 6 mg / 10 mL UNII 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • 2 mg / 10 mL 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.
  • 5 mg / 10 mL UNII KME849MC7A
    Disodium HEDTA is a chelating agent, a chemical that binds to metal ions. It's used in medicines to prevent metal impurities from causing discoloration or degradation of the product.
  • 0.29 mg / 10 mL 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.
  • 2 mL / 10 mL 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.
  • 0.006 mL / 10 mL UNII 4N14V5R27W
    A natural flavoring derived from raspberry fruit that gives medicines a pleasant taste. It helps mask bitter or unpleasant flavors to make medications easier to swallow.
  • 40 mg / 10 mL 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.
  • 20 mg / 10 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.
  • 12 mg / 10 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 2.3 mL / 10 mL 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.
  • 10 mL / 10 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.

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

The official label also statesAloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

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 applicationpart343 (OTC MONOGRAPH NOT FINAL)
Labeler code65131
First marketedDec 2016
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 🔄 Drug Interactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

Indications & Use Bronchial congestion Irritation of the respiratory passages Nasal congestion Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive Antitussive Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

⏱️ Dosage and Administration 47 words ▾

Dosage and Administration Do not exceed 4 doses in a 24 hour period Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 6 hours. Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 6 hours

⚠️ Warnings 197 words ▾

Warnings Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlem (mucus). Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.

A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache. As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product.

Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

🔄 Drug Interactions 55 words ▾

Drug Interaction Precautions 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 2 weeks after stopping the MAOI drug. If you are uncertain whether your presciption drug contains an MAOI, consult a health professional before taking this product

🧪 Active Ingredient 10 words ▾

Active Ingredients Acetaminophen Chlorpheniramine Maleate Dextromethorphan HBr Guaifenesin Phenylephrine HCl

🧪 Inactive Ingredients 31 words ▾

Iactive Ingredient Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

🎯 Purpose 6 words ▾

Purpose Analgesic Antihistaminic Antotussive Expectorant Decongestant

📄 Keep Out of Reach of Children 22 words ▾

Keep Out Of the Reach Of children In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately

📄 Package Label / Principal Display Panel 37 words ▾

Package Label Principal Display Panel BUSAIIBOX

Iactive Ingredient Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

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 Not Final". 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.
← 65131-0111-21 · LABORATORIO 65131-0180-98 · 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.