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Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid, 118 mL — NDC 58593-235-04 (Billing 58593-0235-04)

by Efficient Laboratories Inc · 118 mL in 1 BOTTLE

This is a package of 118 mL of Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid from Efficient Laboratories Inc, no longer marketed (first marketed Oct 2007), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 5 package sizes.

NDC 58593-0235-04
🏷️ FDA NDC (as labeled) 58593-235-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes5 compare ↓
Main listing for product 58593-235 · Also comes in: 10 ml 58593-235-10 178 ml 58593-235-06 237 ml 58593-235-08 296 ml 58593-235-29
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

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
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58593-235-04
Product NDC 58593-235
11-digit billing NDC 58593023504
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 Discontinued
FDA listing status Discontinued by firm
Marketing start 2007-10-01
Marketing end 2027-03-31
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1044949
Why two NDCs? The FDA registers this code as 58593-235-04 — 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 → 58593-0235-04. 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

🧪 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.

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: 10 ml 178 ml 237 ml 296 ml
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
58593-0235-04 You're viewing this Main listing 118 mL in 1 BOTTLE 2015-01-01 — Discontinued by firm
58593-0235-06 58593-235-06 178 mL in 1 BOTTLE 2007-10-01 — Discontinued by firm
58593-0235-08 58593-235-08 237 mL in 1 BOTTLE 2015-01-01 — Discontinued by firm
58593-0235-10 58593-235-10 10 mL in 1 POUCH 2019-01-01 Mar 31, 2027 Active
58593-0235-29 58593-235-29 296 mL in 1 BOTTLE 2015-01-01 — Discontinued by firm

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle.
How does this package differ from NDC 58593-0235-10?
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. This page's package is the 118 mL one, while NDC 58593-0235-10 is the 10 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?
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
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 70000-0133-01 Cardinal 1 bottle $0.018 — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 70677-1187-01 Strategic 1 bottle $0.019 — FDA listed —
Tussin Multi Symptom Cold CF Adult 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 00904-6537-20 Major 1 bottle $0.021 — Availability likely —
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 83324-0155-04 QUALITY 1 bottle $0.021 — Availability likely —
Robitussin Peak Cold Multi-Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 00031-8742-14 Haleon 1 bottle — — FDA listed —
Bactimicina Cough And Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 24286-1546-04 DLC 1 bottle — — FDA listed —
Tukol Honey Children Cough and Congestion 5 mg/2.5mL; 50 mg/2.5mL; 2.5 mg/2.5mL 50066-0301-04 Genomma 1 bottle — — FDA listed —
Tukol Multi Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0504-24 Genomma 118 ml — — FDA listed —
Tukol Cough and Congestion 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0510-04 Genomma 1 bottle — — FDA listed —
Tukol X-Pecto Miel Multi Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0533-24 Genomma 118 ml — — FDA listed —
Tukol Cough And Cold Honey Flavor 100 mg/5mL; 5 mg/5mL; 10 mg/5mL 50066-0534-04 Genomma 1 bottle — — FDA listed —
GoodSense Tussin CF Multi-Symptom Cold, Raspberry 5 mg/5mL; 10 mg/5mL; 100 mg/5mL 50804-0256-04 Geiss, 118 ml — — FDA listed —
Desgen Dm 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 52083-0646-16 Kramer 474 ml — — FDA listed —
Mucosan Multi-Symptom Cherry 10 mg/5mL; 5 mg/5mL; 100 mg/5mL 53145-0693-04 Menper 1 bottle — — FDA listed —
Mucosan Multi-Symptom Honey 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53145-0695-04 Menper 1 bottle — — FDA listed —
Tussin CF Multi-Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53942-0504-26 DeMoulas 237 ml — — FDA listed —
Tussin CF 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53943-0504-26 Discount 237 ml — — FDA listed —
Multi-Symptom Cold 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 55319-0201-36 Family 1 bottle — — FDA listed —
Broncomiel Adults 200 mg/10mL; 10 mg/10mL; 20 mg/10mL 55758-0512-09 Pharmadel 1 bottle — — FDA listed —
Rompe Pecho CF 10 mg/5mL; 100 mg/5mL; 5 mg/5mLthis 58593-0235-04 Efficient 118 ml — — Discontinued —
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 63941-0382-04 Best 1 bottle — — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 63941-0823-04 Best 1 bottle — — FDA listed —
Tussin CF Non Drowsy Multi Symptom 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0266-18 WinCo 1 bottle — — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0470-04 WinCo 1 bottle — — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0691-04 WinCo 1 bottle — — FDA listed —
Tussin Cf 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 76281-0504-24 AptaPharma 118 ml — — 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

🏛️
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.

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

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.

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

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 64 words ▾

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 60 words ▾

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 27 words ▾

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 53 words ▾

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 6 words ▾

Purpose Cough Suppressant Expectorant Nasal Decongestant

📄 Do Not Use 101 words ▾

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • a persistant or chronic cough a cough that is accompanied by excessive phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. Stop use and ask doctor if symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition. nervousness, dizziness, or sleeplessness occurs

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 23 words ▾

Questions or Comments? 305-805-3456 Monday - Friday 9AM to 5PM EST www.efficientlabs.com Distributed by Efficient Laboratories, Inc., Miami, Fl 33166 Made in U.S.A.

📄 Package Label / Principal Display Panel 1 words ▾

label

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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 10 ml (58593-0235-10), 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.
← 58593-0225-06 · Efficient 58593-0255-04 · Efficient →
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.