On this page

Cough DM

dextromethorphan polistirex · Suspension

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
Cough DM
Generic name
dextromethorphan polistirex
Dosage form
Suspension
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Meijer Distribution Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
14
Packages
20
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dextromethorphan Hydrobromide 30 mg/5mL 1094538 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension
Route of administration
Oral
Presentations
34

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
091135
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 25, 2012
Sponsor
TRIS PHARMA INC
Products on application
1
Submissions recorded
3
Products approved under application 091135.
Product Trade name Form Strength Ingredient Status TE Flags
091135-001 DEXTROMETHORPHAN POLISTIREX SUSPENSION, EXTENDED RELEASE DEXTROMETHORPHAN POLISTIREX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 091135.
Type No. Action Status Date Review
Supplement 2 Manufacturing (CMC) Approved October 27, 2014 —
Supplement 1 Manufacturing (CMC) Approved September 28, 2012 —
Original application 1 Approved May 25, 2012 —

Review documents

  • 0 · Original application · May 17, 2017
  • 0 · Original application · May 30, 2012

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250926). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250926 HUMAN OTC DRUG · 20250512 HUMAN OTC DRUG · 20250507 HUMAN OTC DRUG · 20200527

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 doctor 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma, or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a Doctor

openFDA Drug Labeling

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

Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough 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
50,236
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 HYDROBROMIDE. 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
17856-6312-1 17856-6312 ATLANTIC BIOLOGICALS CORP. 5 mL in 1 CUP (17856-6312-1) November 18, 2024
17856-6312-2 17856-6312 ATLANTIC BIOLOGICALS CORP. 10 mL in 1 CUP (17856-6312-2) November 18, 2024
72288-652-28 72288-652 Amazon.com Services LLC 1 BOTTLE in 1 CARTON (72288-652-28) / 148 mL in 1 BOTTLE (72288-652-00) August 13, 2026
59779-384-21 59779-384 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-384-21) / 89 mL in 1 BOTTLE August 28, 2012
59779-384-28 59779-384 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-384-28) / 148 mL in 1 BOTTLE July 18, 2013
59779-958-21 59779-958 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-958-21) / 89 mL in 1 BOTTLE July 16, 2013
59779-958-28 59779-958 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-958-28) / 148 mL in 1 BOTTLE December 27, 2013
37808-384-21 37808-384 H E B 1 BOTTLE in 1 CARTON (37808-384-21) / 89 mL in 1 BOTTLE August 30, 2012
37808-384-28 37808-384 H E B 1 BOTTLE in 1 CARTON (37808-384-28) / 148 mL in 1 BOTTLE April 13, 2016
42507-384-21 42507-384 HyVee Inc 1 BOTTLE in 1 CARTON (42507-384-21) / 89 mL in 1 BOTTLE (42507-384-00) September 2, 2012
42507-384-28 42507-384 HyVee Inc 1 BOTTLE in 1 CARTON (42507-384-28) / 148 mL in 1 BOTTLE (42507-384-01) August 5, 2013
30142-384-21 30142-384 Kroger Company 1 BOTTLE in 1 CARTON (30142-384-21) / 89 mL in 1 BOTTLE August 28, 2012
0904-6312-56 0904-6312 Major Pharmaceuticals 1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE September 6, 2012
41250-384-28 41250-384 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-384-28) / 148 mL in 1 BOTTLE July 31, 2013
41250-899-28 41250-899 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-899-28) / 148 mL in 1 BOTTLE March 25, 2015
41250-958-28 41250-958 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-958-28) / 148 mL in 1 BOTTLE July 31, 2013
56062-384-21 56062-384 Publix Super Markets Inc 1 BOTTLE in 1 CARTON (56062-384-21) / 89 mL in 1 BOTTLE February 25, 2014
21130-538-21 21130-538 Safeway 1 BOTTLE in 1 CARTON (21130-538-21) / 89 mL in 1 BOTTLE May 4, 2026
0363-0384-21 0363-0384 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0384-21) / 89 mL in 1 BOTTLE August 28, 2012
0363-0384-28 0363-0384 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0384-28) / 148 mL in 1 BOTTLE July 16, 2013
17856-6312 17856-6312 ATLANTIC BIOLOGICALS CORP. — September 6, 2012
72288-652 72288-652 Amazon.com Services LLC — August 13, 2026
59779-384 59779-384 CVS Pharmacy — August 28, 2012
59779-958 59779-958 CVS Pharmacy — July 16, 2013
37808-384 37808-384 H E B — August 30, 2012
42507-384 42507-384 HyVee Inc — September 2, 2012
30142-384 30142-384 Kroger Company — August 28, 2012
0904-6312 0904-6312 Major Pharmaceuticals — September 6, 2012
41250-384 41250-384 Meijer Distribution Inc — August 27, 2012
41250-899 41250-899 Meijer Distribution Inc — March 25, 2015
41250-958 41250-958 Meijer Distribution Inc — July 8, 2013
56062-384 56062-384 Publix Super Markets Inc — February 25, 2014
21130-538 21130-538 Safeway — May 4, 2026
0363-0384 0363-0384 Walgreen Company — August 28, 2012

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 · 11 sections on this page.