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Rompe Pecho Max Acetaminophen, Dextromethorphan HBr, Guaifenesin 650 mg/20mL; 20 mg/20mL; 400 mg/20mL Liquid, 237 mL — NDC 58593-0005-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rompe Pecho Max Acetaminophen, Dextromethorphan HBr, Guaifenesin 650 mg/20mL; 20 mg/20mL; 400 mg/20mL Liquid, 237 mL — NDC 58593-005-08 (Billing 58593-0005-08)

by Efficient Laboratories Inc · 237 mL in 1 BOTTLE

This is a package of 237 mL of Rompe Pecho Max Acetaminophen, Dextromethorphan HBr, Guaifenesin 650 mg/20mL; 20 mg/20mL; 400 mg/20mL Liquid from Efficient Laboratories Inc, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 58593-0005-08
🏷️ FDA NDC (as labeled) 58593-005-08 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58593-005-08
Product NDC 58593-005
11-digit billing NDC 58593000508
RxCUI 2680300
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 4f86985c-48f3-2148-e063-6394a90ae2f1
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 2026-04-01
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 2680300
Why two NDCs? The FDA registers this code as 58593-005-08 — 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 → 58593-0005-08. 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

🧪 What is this product?

Rompe Pecho Max is an oral liquid cold and cough product sold over the counter as an OTC monograph drug. It combines three active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and guaifenesin, an expectorant typically used to help thin and clear mucus. This combination is commonly used to manage multiple cold 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
58593-0005-08 You're viewing this Main listing 237 mL in 1 BOTTLE 2026-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Tussin Cf 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 70000-0739-01 Cardinal 1 bottle $0.025 — Availability likely —
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 00031-0100-04 Haleon 1 bottle — — FDA listed —
Good Sense Tussin 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 00113-2009-34 L. 1 bottle — — FDA listed —
Tussin Severe 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 42507-0581-26 HyVee 1 bottle — — FDA listed —
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 51316-0089-08 CVS 1 bottle — — FDA listed —
Severe Cough Cold And Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 51316-0189-26 CVS 1 bottle — — FDA listed —
Geri Care Tussin CF Max 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 57896-0596-08 GERI-CARE 237 ml — — FDA listed —
Rompe Pecho Max 650 mg/20mL; 20 mg/20mL; 400 mg/20mLthis 58593-0005-08 Efficient 237 ml — — FDA listed —
Topcare Tussin Cf Max 650 mg/20mL; 20 mg/20mL; 400 mg/20mL 76162-0198-26 Topco 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 marketedApr 2026
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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

Uses • temporarily relieves these common cold/flu symptoms: cough due to minor throat and bronchial irritation • minor aches and pains• headache• sore throat • temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

⏱️ Dosage and Administration 78 words ▾

Directions do not take more than directed (see overdose warning) Do not exceed more than 6 doses in any 24-hour period Shake well before use measure only with dosing cup provided keep dosing cup with product mL=miliiter TSP=teaspoonful this adult product is not intended for use in children under 12 years of age Age Dose adults and children 12 years of age and over 20 mL every 4 hours children under 12 years of age do not use

⚠️ Warnings 107 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur f you take • more than 6 doses in 24 hours, which is the maximum daily amount for this prcx:luct • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily wh le using this product. Allergy alert : Acetaminophen may cause severe skin reactions.

Symptoms may include: • skin reddening • blisters• rash If a skin reaction occurs,stop use and seek medical help right away. Sore throat warning: If sore throat is severe,persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting,consult a doctor promptly.

🧪 Active Ingredient 25 words ▾

Active Ingredients: (in each 30ml doses cup) Purpose Acetaminophen 650mg ............................................................ Pain reliever/fever reducer Dextromethorphan HBr 20 mg ..................................................Cough Suppressant Guaifenesin 400 mg ................................................................. Expectorant

🧪 Inactive Ingredients 60 words ▾

Inactive ingredients : blue cohosh root extract, citric acid, echinacea root extract, eucalyptus oil, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, Propylparaben, slippery elm bark extract, sodium chloride, sucralose, water, wild cherry bark extract and zinc sulfate.

🎯 Purpose 7 words ▾

Purpose Pain reliever/fever reducer Cough Suppressant Expectorant

📄 Do Not Use 81 words ▾

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now 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 a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 75 words ▾

Ask a doctor before use if you have • heart disease • liver disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to an enlarged prostate gland • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema• a cough that is followed by excessive phlegm (mucus).

Ask a doctor or pharmacist before use if you are: • taking the blood thinning drug warfarin

📄 When Using This Product 10 words ▾

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 65 words ▾

Stop use and ask a doctor if: • symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash, or persistent headache • Nervousness, dizziness or sleeplessness occurs • fever gets worse or last more than 3 days • redness or swelling is present or new symptoms occur. A persistent cough may be a sign of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 57 words ▾

Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 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 2 words ▾

label box

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 Acetaminophen, Dextromethorphan HBr, Guaifenesin — the ingredient across all brands.

Top reported reactions

Fatigue34
Dyspnoea27
Pneumonia27
Nausea26
Pain25
Fall22
Covid-1920

Age at onset

Adult41
Elderly35

Reporter sex

439 reports
Male · 35%
Female · 64%
Unknown · 1%

Serious outcomes

Hospitalization115
Death29
Life-threatening11
Disabling8
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 40 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 ✓ Available
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 Efficient Laboratories Inc. Listing status can change — the directory data on this page refreshes weekly.
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.
← 58593-0003-06 · Efficient 58593-0006-04 · 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.