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Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution — NDC 65131-0097-53 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution — NDC 65131-097-53 (Billing 65131-0097-53)

by LABORATORIO MAGNACHEM INTERNATIONAL SRL · 6 PACKAGE in 1 BOX / 13 g in 1 PACKAGE

This is a package of Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution from LABORATORIO MAGNACHEM INTERNATIONAL SRL, marketed since Sep 2013 and currently FDA-listed.

NDC 65131-0097-53
🏷️ FDA NDC (as labeled) 65131-097-53 billing pads the product segment with a zero
This package
Contains13 g in 1 package Pack sizes2 compare ↓
Product page 65131-0097-12 Also comes in: 13 g 65131-097-12
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 65131-097-53 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65131 labeler · 097 product · 53 package
Package marketed since
Sep 28, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0805418097532
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Feb 16, 2024 — Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate. (Global Corporation) · FDA recall D-0387-2024
Lots / codes: Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025 · reported Mar 20, 2024
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65131-097-53
Product NDC 65131-097
11-digit billing NDC 65131009753
UNII 362O9ITL9D, V1Q0O9OJ9Z
UPC 0805418097532
Application # M
SPL Set ID b7d3f54e-59ef-4b85-a88d-b053058dc1f6
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-01
Route ORAL
Dosage form GRANULE, FOR SOLUTION
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Why two NDCs? The FDA registers this code as 65131-097-53 — 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 → 65131-0097-53. 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.

Clinical

🧪 What is this product?

Broncochem Cold and Flu Tea is an over-the-counter oral granule product marketed under FDA's monograph rules for cold and flu symptom relief. The granules dissolve in hot water and contain acetaminophen, typically used to reduce fever and relieve minor aches and pain, and chlorpheniramine maleate, an antihistamine commonly used to help reduce sneezing and runny nose. This combination product is intended for people seeking multi-symptom cold and flu relief in a tea form.

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.
Try another pack size: 13 g
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
65131-0097-12 65131-097-12 Main listing 25 PACKAGE in 1 BOX / 13 g in 1 PACKAGE 2017-09-28 — Active
65131-0097-53 You're viewing this 6 PACKAGE in 1 BOX / 13 g in 1 PACKAGE 2017-09-28 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 package in 1 box / 13 g in 1 package.
What NDC number is used to bill for this package of Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate 500 mg/13g; 4 mg/13g Granule, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Broncochem Cold And Flu Tea 500 mg/13g; 4 mg/13gthis 65131-0097-53 LABORATORIO 13 g — — 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

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 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.

What it looks like

Color yellow
FlavorLime
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.

  • 0.001 mL / 13 g UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 66 mg / 13 g UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • 1500 mg / 13 g 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.
  • 100 mg / 13 g UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • 1000 mg / 13 g UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 10 mg / 13 g UNII 04JA59TNSJ
    Phenylephrine hydrochloride is a decongestant chemical that narrows blood vessels in nasal passages. It's included in cold and allergy products to help relieve nasal congestion.
  • 0.433 mg / 13 g UNII 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 40 mg / 13 g UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 28.43 mg / 13 g 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.
  • 9483 mg / 13 g UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 166.6 mg / 13 g UNII K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.

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

The official label also statesAscorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

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 marketedSep 2013
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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 177 words ▾

Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain. Headache.

Nasal and sinus congestion. Runny nose. Sneezing Itchy nose or throat.

Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation. Temporarily reduces fever.

Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

⏱️ Dosage and Administration 128 words ▾

Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen, severe liver damage may occur if you take: More than 6 packets in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. three (3) or more alcoholic drinks every day while using this product. Sore Tthroat warning: If sore throat is severe, persists for more than 2 days, is accompainied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Active Ingredients Acetaminophen.

Phenylephrine Hydrochloride. Chlorpheniramine Maleate Purpose Pain reliever/fever reducer Nasal decongestant Antihistamine Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms. Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains.

Minor sore throat pain. Headache. Nasal and sinus congestion.

Runny nose. Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever.

Cough due to minor throat and bronchial irritation. Temporarily reduces fever. Dosage and Administration Do not use more than directed.

Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor.

Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating. Do not over heat.

Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

🧪 Active Ingredient ~1 min read ▾

Active Ingredients Acetaminophen. Phenylephrine Hydrochloride. Chlorpheniramine Maleate Purpose Pain reliever/fever reducer Nasal decongestant Antihistamine Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms.

Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain. Headache.

Nasal and sinus congestion. Runny nose. Sneezing Itchy nose or throat.

Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation. Temporarily reduces fever.

Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor. Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes. If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

🧪 Inactive Ingredients 23 words ▾

Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

🎯 Purpose ~1 min read ▾

Purpose Pain reliever/fever reducer Nasal decongestant Antihistamine Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms. Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain.

Headache. Nasal and sinus congestion. Runny nose.

Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation.

Temporarily reduces fever. Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor.

Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes.

If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating. Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

📄 Keep Out of Reach of Children 220 words ▾

Keep Out of the Reach of Children In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms. Indications and Usage Temporarily relieves these symptoms due to a cold: Minor aches and pains. Minor sore throat pain.

Headache. Nasal and sinus congestion. Runny nose.

Sneezing Itchy nose or throat. Itchy, watery eyes due to hay fever. Cough due to minor throat and bronchial irritation.

Temporarily reduces fever. Dosage and Administration Do not use more than directed. Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor.

Children under 4 years of age-Do not ue. Children from 4 to 12 years of age-Do not use unless directed by a doctor. Adults and children 12 years of age and over-One packet Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes.

If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating. Do not over heat. Inactive Ingredients Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

📄 Package Label / Principal Display Panel 39 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL BOX - BRONCOCHEM COLD & FLU TEA_6 Packs.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANNEL BOX - BRONCOCHEM COLD & FLU TEA _25 Packs-01.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL LABEL - BRONCOCHEM COLD & FLU TEA-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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 13 g (65131-0097-12). 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?
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.
← 65131-0091-08 · LABORATORIO 65131-0098-47 · 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.