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Delsym
Dextromethorphan · Suspension, Extended Release
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Dextromethorphan | 30 mg/5mL | 1115329 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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 BookCodes 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses 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
openFDA Drug LabelingPurpose Cough suppressant
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-0224 NDC: 50090-0224-0 89 mL in a BOTTLE / 1 in a CARTON
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.