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Dometuss Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCL 2 mg/5mL; 5 mg/5mL; 10 mg/5mL Liquid, 118 mL

by Dextrum Laboratories, Inc · 118 mL in 1 BOTTLE, PLASTIC (65852-002-04)
NDC 65852-0002-04
🏷️ FDA NDC (as labeled) 65852-002-04 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 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

🆔 Identity & classification

FDA NDC (as labeled) 65852-002-04
Product NDC 65852-002
11-digit billing NDC 65852000204
RxCUI 1363752
UNII V1Q0O9OJ9Z, 04JA59TNSJ, 9D2RTI9KYH
Application # M012
SPL Set ID 3fcace53-a81f-e774-e063-6294a90a32fa
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Rece
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-21
Route ORAL
Dosage form LIQUID
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 65852-002-04 — 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 → 65852-0002-04. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists
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

LabelerDextrum Laboratories, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code65852
First marketedJan 2016
Product typeHuman Otc Drug
Portfolio10 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

🧪 What is this product?

Dometuss is an oral liquid cold and cough product sold over the counter under FDA's OTC monograph rules. It contains three active ingredients: chlorpheniramine maleate, an antihistamine typically used to relieve allergy and cold-related symptoms like sneezing and itching; dextromethorphan hydrobromide, a cough suppressant commonly used to reduce cough; and phenylephrine hydrochloride, a decongestant typically used to relieve nasal congestion. This combination product is intended for symptomatic relief of multiple cold symptoms in a single dose.

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.

🧪 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 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 X6JU3FX5UU
    A salt derived from citric acid, sodium citrate monohydrate acts as a buffer in medicines to stabilize pH and prevent ingredient breakdown. It may also help improve taste and texture.
  • 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 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.

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

The official label also statesInactive ingredients: Citric Acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bio-Rytuss 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 45737-0250-16 Advanced 473 ml — — FDA listed —
Gencontuss 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 52083-0650-16 KRAMER 473 ml — — FDA listed —
Dometuss 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 53809-0222-04 Domel 118 ml — — FDA listed —
Giltuss Allergy Plus Cough and Congestion 4 mg/10mL; 20 mg/10mL; 10 mg/10mL 58552-0138-04 Gil 1 bottle — — FDA listed —
Giltuss Childrens Allergy Plus Cough and Congestion 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 58552-0139-04 Gil 1 bottle — — FDA listed —
Dometuss 2 mg/5mL; 5 mg/5mL; 10 mg/5mLthis 65852-0002-04 Dextrum 118 ml — — FDA listed —
Giltuss Allergy Plus 20 mg/10mL; 10 mg/10mL; 4 mg/10mL 65852-0017-04 Dextrum 1 bottle — — FDA listed —
Giltuss Childrens Allergy Plus 5 mg/5mL; 2 mg/5mL; 10 mg/5mL 65852-0018-04 Dextrum 1 bottle — — FDA listed —
Rycontuss 5 mg/5mL; 2 mg/5mL; 10 mg/5mL 65852-0021-16 Dextrum 473 ml — — FDA listed —
Rycontuss Cherry Flavor 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 76117-0001-16 Okendpharma, 473 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

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 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 Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCL — the ingredient across all brands.

Top reported reactions

Dizziness4
Abdominal Discomfort3
Condition Aggravated3
Dyspepsia3
Fatigue3
Gastrooesophageal Reflux Disease3
Illness3

Age at onset

Adult1

Reporter sex

20 reports
Male · 35%
Female · 65%

Serious outcomes

Death2
Disabling1
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 NDCDescription Marketing startStatus
65852-0002-04 You're viewing this 118 mL in 1 BOTTLE, PLASTIC (65852-002-04) 2016-01-21 Active

🧭 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) ✓ 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 65852-002-04, 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: 65852-0002-04, written without dashes as 65852000204. 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 65852-0002-04, the first segment (65852) is the labeler code FDA assigned to Dextrum Laboratories, Inc; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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: 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.

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 61 words ▾

Indication and usage section : Indication and usage section: adults and children 12 year of age and over--- 2 teaspoonful (10ml) every 4 hours Childrens 6 to under 12 years of age------ i teaspoonful (5ml) every 4 hours Childrens under 6 years of age------ask a doctor Do not exceed more than 6 doses in any 24 hours period. indication and user

⏱️ Dosage and Administration 55 words ▾

Directions Directions: Do not exceed more than 6 doses in a 24 hour period. Adults and children 12 years of age and over 2 teaspoonful (10 ml) every 4 hours. Children 6 to under 12 years of age 1 teaspoonful (5 ml) every 4 hours. Children under 6 years of age Ask a doctor. Directions

⚠️ Warnings 67 words ▾

Warnings: Do not use To sedate a child or to make a child sleepy. If you are now taking a prescription monoamine oxidose inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditiosn 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, asl a doctor or pharmacist before taking this product. Warning

📦 Storage and Handling 15 words ▾

Other information Other information: store at room temperature between 15-30 C( 59-86 F) Other Information

🧪 Active Ingredient 16 words ▾

Active Ingredients ( in each 5ml-teaspoonful) Chlorpheniramine Maleate 2mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg active

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients Inactive ingredients: Citric Acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose. Inactive Ingredients

🎯 Purpose 50 words ▾

Anthistamine cough suppresant nasal descongestant. Use For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever. Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold. temporary restores freer breathing through the nose. purpose

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65852-0001-02 · Dextrum 65852-0003-04 · 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.