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Rompe Pecho CF Brompheniramine Maleate, Dextromethorphan HBr 4 mg/5mL; 10 mg/5mL Liquid — NDC 65852-0013-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rompe Pecho CF Brompheniramine Maleate, Dextromethorphan HBr 4 mg/5mL; 10 mg/5mL Liquid — NDC 65852-013-06 (Billing 65852-0013-06)

by Dextrum Laboratories, Inc · 1 BOTTLE, PLASTIC in 1 CARTON / 178 mL in 1 BOTTLE, PLASTIC

This is a package of Rompe Pecho CF Brompheniramine Maleate, Dextromethorphan HBr 4 mg/5mL; 10 mg/5mL Liquid from Dextrum Laboratories, Inc, marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 65852-0013-06
🏷️ FDA NDC (as labeled) 65852-013-06 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 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 65852-013-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65852 labeler · 013 product · 06 package
Package marketed since
Oct 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6585201306 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65852-013-06
Product NDC 65852-013
11-digit billing NDC 65852001306
RxCUI 2676758
UNII IXA7C9ZN03, 9D2RTI9KYH
Application # M012
SPL Set ID 401a97af-36ae-4e54-e063-6294a90ab3ee
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-01
Route ORAL
Dosage form LIQUID
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 2676758
Why two NDCs? The FDA registers this code as 65852-013-06 — 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 → 65852-0013-06. 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 Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines
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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Brompheniramine is used to treat allergy and cold symptoms: sneezing runny nose itching of the nose or throat red, itchy, watery eyes Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
🧪 What is this product?

Rompe Pecho CF is an oral liquid cough and cold product that contains two active ingredients. Brompheniramine maleate is an antihistamine typically used to relieve allergy symptoms and sneezing. Dextromethorphan hydrobromide is a cough suppressant commonly used to reduce coughing. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for over-the-counter cold and cough remedies rather than being individually reviewed as a new drug application.

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
65852-0013-06 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 178 mL in 1 BOTTLE, PLASTIC 2023-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rompe Pecho CF CF 10 mg/5mL; 4 mg/5mL 58593-0001-06 Efficient 178 ml — — FDA listed —
Rompe Pecho SF Flu SF Flu 10 mg/5mL; 4 mg/5mL 58593-0002-06 Efficient 178 ml — — FDA listed —
Rompe Pecho CF 4 mg/5mL; 10 mg/5mLthis 65852-0013-06 Dextrum 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

💡 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 D982V7VT3P
    A plant extract from the narrow-leafed coneflower root, used as a natural flavor, color, or botanical ingredient in some formulations to add taste and appearance to the medicine.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 61ZBX54883
    Licorice is a natural extract from the licorice plant root. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • 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 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 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 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.

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

The official label also statesIvactives ingredient section Blue cohosh root extract, echinacea root extract, eucalyptus oil, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound(flower, leaft, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum extract, potassium sorbate, propylene glycol, propylparaben, slippery eilm 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.

Manufacturer & labeler

LabelerDextrum Laboratories, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code65852
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Dextrum Laboratories, Inc labeler code 65852

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 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

Indication and usage section Indication and usage section Do not exceed more than 6 dosesin a 24-hour period Shake before use measure only with dosing cup provided keep dosing cup with product ml=milliliters TSP=teaspoonful This adult product is no intented for use in children under 12 years of age Adult and children 12 years of age and over 5ml (1 teaspoonful) every 4 hours children under 12 years of age Do not use indication an user

⏱️ Dosage and Administration 74 words ▾

Dosage & Administration section Dosage & Administration section Do not exceed more than 6 dosesin a 24-hour period Shake before use measure only with dosing cup provided keep dosing cup with product ml=milliliters TSP=teaspoonful This adult product is no intented for use in children under 12 years of age Adult and children 12 years of age and over 5ml (1 teaspoonful) every 4 hours children under 12 years of age Do not use dosage

⚠️ Warnings 61 words ▾

Warnings Warnings Do no exceed recommended dosage Do not use if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or Parkinson's disease), or 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. Warning

🧪 Active Ingredient 18 words ▾

Active ingredient section Active ingredient section Brompheniramine melate 4mg.... Antihistamine Dextromethorphan HBr 10 mg... Cough suppressant active ingredient

🧪 Inactive Ingredients 60 words ▾

Ivactives ingredient section Ivactives ingredient section Blue cohosh root extract, echinacea root extract, eucalyptus oil, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound(flower, leaft, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum extract, potassium sorbate, propylene glycol, propylparaben, slippery eilm bark extract, sodium chloride, sucralose, water, wild cherry bark extract and zinc sulfate. inactive

🎯 Purpose 8 words ▾

Purpose section Purpose section Antihistaminic Cough suppressant purpose

📄 Ask a Doctor Before Use If 68 words ▾

Ask a doctor section Ask a doctor section Ask a doctor before use: If you have heart disease, glaucoma, high pressure, thyroid disease, diabetes, dificulty in urination due to enlargement of the prostate gland, a persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough tha is accompanied by excessive phlegm (mucus), a breathing problem such as emphysema or chronic bronchitis. Ask a doctor

📄 Ask a Doctor or Pharmacist Before Use If 26 words ▾

Ask a doctor and pharmacist section Ask a doctor/pharmacist section Ask a doctor or pharmacistbefore use if you are taking tranquilizers or sedatives Ask a doctor

🤰 If Pregnant or Breast-Feeding 21 words ▾

Pregnancy or breast feeding section Pregnancy or breast feeding section If pregnancy or breaft-feeding, ask a heath professional before use pregnant

📄 Keep Out of Reach of Children 31 words ▾

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

📄 Questions or Comments 15 words ▾

Question section Question section Question or comments: 305-805-3456 Monday-Friday (9am - 5pm) or www.efficientlabs.com question

📄 Package Label / Principal Display Panel 36 words ▾

Principal display panel Efficient Rompe Pecho CF Cold & Flu Antihistamine Cough Suppressant Brompheniramine Melate Dextromethorphan HBr Advanced Formula Alcohol Free Adults and Children 12 years and over Content: 6 FL Oz (178 ml) principal panel

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 Dextrum Laboratories, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dextrum 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.
← 65852-0012-04 · Dextrum 65852-0015-01 · Dextrum →
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.