Prescription medicine

Brompheniramine and dextromethorphan and pseudoephedrine First approved as Dimetane-Dx

Brompheniramine and dextromethorphan and pseudoephedrine (Dimetane-Dx) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.0682 per mL (Bromphen-pse-dm 2-30-10 mg/5 mL) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the brompheniramine and dextromethorphan and pseudoephedrine FDA label on DailyMed (effective March 16, 2026, Acella Pharmaceuticals, LLC); the NDA 19279 record on Drugs@FDA; every brompheniramine and dextromethorphan and pseudoephedrine label on DailyMed.

Highlights of the record

FDA label of March 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Forms and strengths

2 mg/5ml / 30 mg/5ml / 10 mg/5ml
10 mg/5ml / 30 mg/5ml / 2 mg/5ml

Syrup; solution.

On the market

Earliest approval on file: August 24, 1984 Dimetane-Dx, Robins Ah; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 12 first June 7, 1985; 8 with a marketed status in Drugs@FDA
Labelers listed (NDC): 14 of which 14 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $0.0682 per mL Bromphen-pse-dm 2-30-10 mg/5 mL
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
FAERS reports: 1 through July 30, 2026

What is brompheniramine and dextromethorphan and pseudoephedrine used for?

From the label: indications and usage
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

FDA pharmacologic class: Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist and alpha-Adrenergic Agonist.

Source: FDA drug label (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide), Acella Pharmaceuticals, LLC, effective March 16, 2026 (SPL set 1045e307-f60d-482d-8e06-40e72b84c651), via openFDA; the full label on DailyMed

Is there a generic for brompheniramine and dextromethorphan and pseudoephedrine (Dimetane-Dx)?

The FDA approved the first generic brompheniramine and dextromethorphan and pseudoephedrine on June 7, 1985. 12 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists brompheniramine and dextromethorphan and pseudoephedrine from 14 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1984 earliest approval on file
1985 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for brompheniramine and dextromethorphan and pseudoephedrine (Dimetane-Dx)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0682 per mL (Bromphen-pse-dm 2-30-10 mg/5 mL), down 18% from $0.0835 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Bromphen-pse-dm 2-30-10 mg/5 mL (generic)

$0.105

$0.0682

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Bromphen-pse-dm 2-30-10 mg/5 mL	Generic	$0.0682 per mL	n/a	-18%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has brompheniramine and dextromethorphan and pseudoephedrine been recalled?

The FDA's Enforcement Report lists 1 recall naming brompheniramine and dextromethorphan and pseudoephedrine since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
March 15, 2021	Class II	Cardinal Health Inc.	CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for brompheniramine and dextromethorphan and pseudoephedrine?

The FDA Adverse Event Reporting System holds 1 report that list brompheniramine and dextromethorphan and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Chills1
Erythema1
Pain1
Rash (named in the label)1
Swelling Face1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other sigma-1 agonists: the pharmacologic class, with prices and generics
Brompheniramine and dextromethorphan and pseudoephedrine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other