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Bisolvine Children Guaifenesin, Dextromethorphan 100 mg/15mL; 10 mg/15mL Liquid — NDC 53145-322-04 (Billing 53145-0322-04)

by MENPER DISTRIBUTORS INC. · 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

This is a package of Bisolvine Children Guaifenesin, Dextromethorphan 100 mg/15mL; 10 mg/15mL Liquid from MENPER DISTRIBUTORS INC., marketed since Jan 2010 and currently FDA-listed. It is this product's only package size.

NDC 53145-0322-04
🏷️ FDA NDC (as labeled) 53145-322-04 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 53145-322-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53145 labeler · 322 product · 04 package
Package marketed since
Jan 18, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0042279802046
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53145-322-04
Product NDC 53145-322
11-digit billing NDC 53145032204
RxCUI 1298228
UNII 495W7451VQ, 9D2RTI9KYH
UPC 0042279802046
Application # M012
SPL Set ID 896a5443-e3d2-4af7-9e27-f1c1899ce038
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-01-18
Route ORAL
Dosage form LIQUID
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1298228
Why two NDCs? The FDA registers this code as 53145-322-04 — 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 → 53145-0322-04. 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

📗 Our plain-language guide HelloPharmacist
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 Read our full Dextromethorphan / Guaifenesin guide →

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
53145-0322-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE 2010-01-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Berro y Cebolla DM 10 mg/15mL; 100 mg/15mL 53145-0080-08 Menper 1 bottle — — FDA listed —
Bisolvine Children 100 mg/15mL; 10 mg/15mLthis 53145-0322-04 MENPER 1 bottle — — FDA listed —
Bisolvine Aloe-Miel 10 mg/15mL; 100 mg/15mL 53145-0402-06 MENPER 1 bottle — — FDA listed —
Broncochem Maximum Cough Kids 10 mg/15mL; 100 mg/15mL 65131-0180-98 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

🏛️
2010
On the market since
Jan 2010
📍
2026
Currently FDA-listed
16 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.

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.

Manufacturer & labeler

LabelerMENPER DISTRIBUTORS INC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53145
First marketedJan 2010
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from MENPER DISTRIBUTORS INC. labeler code 53145

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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

⏱️ Dosage and Administration 42 words ▾

Directions Age Dose Children 6 to under 12 years of age 1 teaspoonful (15 mL) every 4 hours Children 2 to under 6 years of age 1/2 teaspoonful (7.5 mL) every 4 hours Children under 2 years of age Consult your doctor

⚠️ Warnings 40 words ▾

Warnings: Do not exceed recommended dosage. A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

🧪 Active Ingredient 14 words ▾

Active Ingredients (in each 15 mL) Guaifenesin 100 mg ................................................ Expectorant Dextromethorphan.............................................. Cough Suppressant

🧪 Inactive Ingredients 16 words ▾

artificial strawberryt-banana flavor, citric acid, fd&c red #40, glycerin, methylparaben, propylene glycol, propylparaben, puridied water, sucrose.

🎯 Purpose 4 words ▾

Purpose Expectorant Cough Suppressant

📄 Keep Out of Reach of Children 107 words ▾

Do not: give this product for persistent or chronic cough, such as occurs with asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Keep out of reach of children In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

📄 Other Information 10 words ▾

store this product between 15° to 30° C (59°-86° F)

📄 Questions or Comments 9 words ▾

Questions? 1-800-560-5223 M-F 9 AM to 4 PM Eastern.

📄 Package Label / Principal Display Panel 2 words ▾

Bisolvine Children

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

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 Bisolvine Children (this brand).

Top reported reactions

Chronic Kidney Disease3
Renal Injury2
Alanine Aminotransferase Increased1
Anaemia Postoperative1
Angiopathy1
Application Site Necrosis1
Arteriosclerosis1

Age at onset

Adult3

Reporter sex

9 reports
Male · 60%
Female · 40%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
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.

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) — 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 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 MENPER DISTRIBUTORS INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MENPER DISTRIBUTORS INC. 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.
← 53145-0319-02 · MENPER 53145-0323-04 · MENPER →
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.