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DEXTROMETHORPHAN POLISTIREX

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
DEXTROMETHORPHAN POLISTIREX
Generic name
Dextromethorphan Polistirex
Dosage form
Suspension, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
8
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dextromethorphan 30 mg/5mL 1115329 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension, Extended Release
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Sigma-1 Agonist [EPC] EPC All 44 members
Sigma-1 Receptor Agonists [MoA] MoA All 44 members
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] EPC All 44 members
Uncompetitive NMDA Receptor Antagonists [MoA] MoA All 44 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218417
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 15, 2026
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
1
Products approved under application 218417.
Product Trade name Form Strength Ingredient Status TE Flags
218417-001 DEXTROMETHORPHAN POLISTIREX SUSPENSION, EXTENDED RELEASE DEXTROMETHORPHAN POLISTIREX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 218417.
Type No. Action Status Date Review
Original application 1 Approved April 15, 2026 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260504). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260504

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Purpose Cough suppressant

Dosage and Administration

openFDA Drug Labeling

Directions shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

Warnings Do not use 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

openFDA Drug Labeling

Ask a doctor before use if you have chronic cough that lasts such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

Adverse event reports

Source: openFDA FAERS
58,576
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DEXTROMETHORPHAN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
58602-610-05 58602-610 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-610-05) / 89 mL in 1 BOTTLE April 15, 2026
58602-610-06 58602-610 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-610-06) / 148 mL in 1 BOTTLE April 15, 2026
58602-611-05 58602-611 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-611-05) / 89 mL in 1 BOTTLE April 15, 2026
58602-611-06 58602-611 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-611-06) / 148 mL in 1 BOTTLE April 15, 2026
58602-617-05 58602-617 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-617-05) / 89 mL in 1 BOTTLE April 17, 2026
58602-617-06 58602-617 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-617-06) / 148 mL in 1 BOTTLE April 17, 2026
58602-618-05 58602-618 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-618-05) / 89 mL in 1 BOTTLE April 17, 2026
58602-618-06 58602-618 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-618-06) / 148 mL in 1 BOTTLE April 17, 2026
58602-610 58602-610 Aurohealth LLC — April 15, 2026
58602-611 58602-611 Aurohealth LLC — April 15, 2026
58602-617 58602-617 Aurohealth LLC — April 17, 2026
58602-618 58602-618 Aurohealth LLC — April 17, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.