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Delsym

Dextromethorphan · Suspension, Extended Release

Over-the-counter NDA RLD 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
Delsym
Generic name
Dextromethorphan
Dosage form
Suspension, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Reckitt Benckiser LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
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
11

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
018658
Application type
NDA · New Drug Application
Approval date
October 8, 1982
Sponsor
RECKITT BENCKISER
Products on application
1
Submissions recorded
26
Products approved under application 018658.
Product Trade name Form Strength Ingredient Status TE Flags
018658-001 DELSYM SUSPENSION, EXTENDED RELEASE DEXTROMETHORPHAN POLISTIREX Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 018658.
Type No. Action Status Date Review
Supplement 34 Labeling Approved March 15, 2024 Standard
Supplement 31 Manufacturing (CMC) Approved September 23, 2019 N/A
Supplement 30 Labeling Approved June 19, 2014 Standard
Supplement 29 Labeling Approved May 16, 2011 Standard
Supplement 28 Manufacturing (CMC) Approved November 10, 2010 Standard
Supplement 27 Labeling Approved April 8, 2010 Standard
Supplement 26 Labeling Approved October 8, 2009 Standard
Supplement 23 Labeling Approved December 5, 2008 Standard
Supplement 22 Manufacturing (CMC) Approved September 28, 2007 N/A
Supplement 18 Manufacturing (CMC) Approved March 8, 2005 Standard
Supplement 17 Manufacturing (CMC) Approved November 10, 2004 Standard
Supplement 16 Manufacturing (CMC) Approved July 10, 2002 Standard
Supplement 15 Labeling Approved January 24, 2002 Standard
Supplement 14 Labeling Approved February 15, 2001 Standard
Supplement 12 Manufacturing (CMC) Approved November 8, 1999 Standard
Supplement 13 Manufacturing (CMC) Approved August 9, 1999 Standard
Supplement 10 Labeling Approved October 26, 1993 —
Supplement 9 Manufacturing (CMC) Approved October 26, 1993 Standard
Supplement 8 Manufacturing (CMC) Approved August 10, 1993 Standard
Supplement 11 Manufacturing (CMC) Approved December 28, 1992 Standard
Supplement 7 Manufacturing (CMC) Approved October 9, 1986 Standard
Supplement 5 Manufacturing (CMC) Approved June 12, 1985 Standard
Supplement 2 Manufacturing (CMC) Approved May 10, 1985 Standard
Supplement 4 Labeling Approved June 11, 1984 —
Supplement 1 Labeling Approved June 11, 1984 —
Original application 1 Type 3 - New Dosage Form Approved October 8, 1982 Standard

Review documents

  • 0 · Supplement · March 19, 2024
  • 0 · Supplement · March 18, 2024
  • 0 · Supplement · August 13, 2020
  • 0 · Supplement · August 11, 2014
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · May 19, 2011
  • 0 · Supplement · November 15, 2010
  • 0 · Supplement · April 13, 2010
  • 0 · Supplement · November 12, 2009
  • 0 · Supplement · December 10, 2008
  • 0 · Supplement · October 4, 2007
  • 0 · Supplement · October 4, 2007
  • 0 · Supplement · April 9, 2007
  • 0 · Supplement · March 10, 2005
  • 0 · Supplement · November 16, 2004
  • 0 · Supplement · January 24, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260527). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260527 HUMAN OTC DRUG · 20250228

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 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. 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.

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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-0224 NDC: 50090-0224-0 89 mL in a BOTTLE / 1 in a CARTON

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
50090-0224-0 50090-0224 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE November 28, 2014
63824-171-22 63824-171 Reckitt Benckiser LLC 2 CARTON in 1 CELLO PACK (63824-171-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE May 4, 2010
63824-171-63 63824-171 Reckitt Benckiser LLC 1 BOTTLE in 1 CARTON (63824-171-63) / 89 mL in 1 BOTTLE May 4, 2010
63824-171-65 63824-171 Reckitt Benckiser LLC 1 BOTTLE in 1 CARTON (63824-171-65) / 148 mL in 1 BOTTLE May 4, 2010
63824-171-75 63824-171 Reckitt Benckiser LLC 1 BOTTLE in 1 CARTON (63824-171-75) / 15 mL in 1 BOTTLE May 4, 2010
63824-175-22 63824-175 Reckitt Benckiser LLC 2 CARTON in 1 CELLO PACK (63824-175-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE May 4, 2010
63824-175-63 63824-175 Reckitt Benckiser LLC 1 BOTTLE in 1 CARTON (63824-175-63) / 89 mL in 1 BOTTLE May 4, 2010
63824-175-65 63824-175 Reckitt Benckiser LLC 1 BOTTLE in 1 CARTON (63824-175-65) / 148 mL in 1 BOTTLE May 4, 2010
50090-0224 50090-0224 A-S Medication Solutions — May 4, 2010
63824-171 63824-171 Reckitt Benckiser LLC — May 4, 2010
63824-175 63824-175 Reckitt Benckiser LLC — May 4, 2010

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.