Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid, 10 mL
by Efficient Laboratories Inc · 10 mL in 1 POUCH (58593-235-10)
NDC 58593-0235-10
🏷️ FDA NDC (as labeled)
58593-235-10
billing pads the product segment with a zero
This package
Contains10 mL
Pack sizes5 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Past resolved recalls for this product (1)
Class II · Aug 24, 2021 · Terminated — Microbial Contamination of Non-Sterile Products (Efficient Laboratories, Inc.) · FDA recall D-0290-2022
🆔 Identity & classification
FDA NDC (as labeled)
58593-235-10
Product NDC
58593-235
11-digit billing NDC
58593023510
RxCUI
1044949
UNII
9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application #
M012
SPL Set ID
96c4dee1-6e66-4442-a7e3-56e874414c17
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
2007-10-01
Marketing end
2027-03-31
Route
ORAL
Dosage form
LIQUID
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 58593-235-10 — 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 → 58593-0235-10. 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.
🏭 Manufacturer & labeler
LabelerEfficient Laboratories Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58593
First marketedOct 2007
Product typeHuman Otc Drug
Portfolio17 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
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Read the full MedlinePlus article ↗🧪 What is this product?
Rompe Pecho CF is an over-the-counter liquid taken by mouth that contains three active ingredients commonly used together for cold and cough symptom relief. Dextromethorphan is a cough suppressant typically used to reduce coughing. Guaifenesin functions as an expectorant, which is commonly used to help thin mucus. Phenylephrine is a decongestant typically used to help relieve nasal congestion. This product is marketed as an OTC monograph drug under FDA regulations for its category.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
-
UNII JTJ6HH6YEH
A plant extract from blue cohosh root. It may be used as a natural flavoring or botanical ingredient in some formulations, though its specific role varies by product.
-
UNII 4N9P6CC1DX
A plant extract from echinacea species, commonly used in herbal formulations. It may serve as a flavoring agent, botanical ingredient, or contribute to the product's intended herbal profile in supplements or botanical medicines.
-
UNII S546YLW6E6
Eucalyptus globulus leaf is a plant-derived ingredient that may serve as a flavoring agent or aromatic component in medications. It is commonly used to add taste or scent to oral formulations.
-
UNII 19FUJ2C58T
Ginkgo biloba leaf is a plant extract used as a flavoring or coloring agent in some medicines. It may also serve as a natural ingredient to support the product's formulation.
-
UNII 2788Z9758H
A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
-
UNII ZW3Z11D0JV
A plant extract from goldenseal root, used as a natural colorant and flavoring agent in some medicines. It may also have mild preservative properties in certain formulations.
-
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.
-
UNII K08036XEJV
Horehound is a plant extract used as a flavoring agent in medicines. It adds a distinctive bitter or minty taste to help mask unpleasant flavors in syrups and lozenges.
-
UNII L7T10EIP3A
A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII JC71GJ1F3L
Myrrh is a natural resin obtained from a tree, traditionally used in medicines and perfumes. It may serve as a flavoring agent, fragrance, or mild preservative in formulations.
-
UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
-
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.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 5D48E975HA
A natural extract from wild cherry bark, used as a flavoring agent to mask bitter tastes in medicines and improve palatability of the product.
-
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.
-
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.
-
UNII 91QY4PXU8Q
A natural plant extract from the inner bark of the slippery elm tree. It's used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
-
UNII 9936O846LI
A plant extract from mullein leaves used as a natural flavoring agent and to add texture or body to liquid formulations. It may help improve the taste or mouthfeel of the medicine.
-
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.
-
UNII 89DS0H96TB
Zinc sulfate is a mineral salt used in medications as a source of zinc. It functions as an active nutritional ingredient in some formulations and may also serve as a buffer or pH stabilizer in tablets and liquids.
21 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.
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.
💲 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 system | Per mL | Per 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
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
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
🏛️
2007
On the market since
Oct 2007
📍
2026
Currently FDA-listed
19 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.
🔬 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 Rompe Pecho CF (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 20%
Female · 80%
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58593-0235-04 | 118 mL in 1 BOTTLE (58593-235-04) | 2015-01-01 | Discontinued by firm |
| 58593-0235-06 | 178 mL in 1 BOTTLE (58593-235-06) | 2007-10-01 | Discontinued by firm |
| 58593-0235-08 | 237 mL in 1 BOTTLE (58593-235-08) | 2015-01-01 | Discontinued by firm |
| 58593-0235-10 You're viewing this | 10 mL in 1 POUCH (58593-235-10) | 2019-01-01 | Active |
| 58593-0235-29 | 296 mL in 1 BOTTLE (58593-235-29) | 2015-01-01 | Discontinued by firm |
You're viewing the smallest of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 58593-0235-10?
NDC 58593-0235-10 contains 10 mL — 10 ml in 1 pouch.
What is the difference between NDC 58593-0235-10 and NDC 58593-0235-04?
Both are Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid — the drug itself is identical. NDC 58593-0235-10 is the 10 mL package, while NDC 58593-0235-04 is the 118 ml package.
What NDC number is used to bill for this package of Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid?
Bill NDC 58593-0235-10 — the 11-digit billing format is 58593023510. 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) | ✓ 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 58593-235-10, 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: 58593-0235-10, written without dashes as 58593023510. 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 58593-0235-10, the first segment (58593) is the labeler code FDA assigned to Efficient Laboratories Inc; the middle segment (0235) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 it is currently marketed — but Efficient Laboratories Inc has reported a marketing end date of 2027-03-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 118 ml (58593-0235-04), 178 ml (58593-0235-06), 237 ml (58593-0235-08). 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?
Efficient Laboratories 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.
📄 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
🎯 Indications and Usage ▾
Uses temporarily relieves cough and nasal congestion as may occur with the common cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
⏱️ Dosage and Administration ▾
Directions Shake well before use Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor. Age Dose adults and children 12 years of age and over 10 mL (2 tsps) every 4 hours children 6 to under 12 years of age 5 mL (1 tsp) every 4 hours children under 6 years of age consult a doctor
⚠️ Warnings ▾
Warnings Do not exceed recommended dosage. Do not use If you are 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 prescription drug contains an MAOI; ask your doctor or pharmacist before taking this product.
🧪 Active Ingredient ▾
Active Ingredients: (in each teaspoonful 5 ml.) Purpose Dextromethorphan HBr 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant Phenylephrine HCL 5 mg .................................................... Nasal Decongestant
🧪 Inactive Ingredients ▾
Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.
🎯 Purpose ▾
Purpose Cough Suppressant Expectorant Nasal Decongestant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.