Active ingredient
Dextromethorphan
129 finished FDA listings contain Dextromethorphan as their only active ingredient; 1,874 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDRIODIDE, DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Gelatin Coated, Capsule, Liquid Filled, Chewable Gel, Liquid, Lozenge, Solution, Suspension, Suspension, Extended Release, Syrup, Tablet, Tablet, Chewable
- Routes
- Oral
- Manufacturers / labelers
- 69
- Strengths listed
- 10 mg/1 · 10 mg/5ml · 15 mg/1 · 15 mg/15ml · 15 mg/5ml · 20 mg/15ml · 20 mg/20ml · 30 mg/1 · 30 mg/10ml · 30 mg/3ml · 30 mg/5ml · 5 mg/1 · 5 mg/5ml · 7.5 mg/5ml
- Brand names in FDA listings
- 12 Hr Relief Cough Dm, Adult Cough Relief, Adult Long Lasting Cough Relief, Basic Care Childrens Cough Dm, Basic Care Cough Dm, Bupropidex, Careone Cough Dm, Childrens 12 Hr Cough Relief, Childrens Cough Dm, Childrens Daytime Mucus, Childrens Giltuss Honey Dm Cough, Childrens Robitussin 12 Hour Cough Relief, Childrens Robitussin Cough Long-Acting, Cough Dm, Cough Dm Childrens, Cough Relief, Cough Relief Adult, Cough Relief Cough Suppressant, Cough Suppressant Adult, Creomulsion Cough Medicine Adult Formula, Creomulsion For Children, Cvs Daytime Cough Relief Chews - Citrus Punch, Cvs Health Cough Suppressant Softgel, Cvs Long Acting Cough, Delsym, Delsym (Dextromethorphan), Delsym Cough, Dextabs, Dextromethorphan Hbr 15 Mg, Dextromethorphan Hbr 15 Mg Liquid Gels, Dextromethorphan Polistirex Extended Release, Dextromethorphan Polistirex Extended-Release, Dg Health Cough Dm, Drx Choice Long Acting Cough, Equaline Cough Dm, Equate Cough Dm, Equate Kids Daytime Dex Cough Gels, Father Johns Medicine, Foster And Thrive 12 Hour Cough Relief, Gencare Long-Acting Cough Relief, Giltuss Diabetic Dm, Giltuss Dm, Giltuss Honey Dm Cough, Good Neighbor Long Acting Cough Adult Tussin, Good Neighbor Pharmacy Cough Dm Er, Good Sense Cough Dm, Goodmeds Cough Relief Dextromethorphan Hbr, Goodmeds Non-Drowsy Cough Relief, Honey Works Kids Honey Cough Syrup, Honey Works Organic Honey, Leader Childrens Cough Dm, Leader Cough Dm, Long Acting Cough Softgels, Mielim Y Mas, Mucinex Childrens Mighty Chews Cough, Mucinex Instasoothe Cough, Nuvicare Long-Acting Cough Relief, Premier Value Tussin Cough Long Acting, Quality Choice Adult Long-Acting Cough Softgel, Quality Choice Long Acting Cough Softgel, Right Remedies Adult Long Lasting Cough Relief Softgel, Robitussin 12 Hour Cough Relief, Robitussin Direct Cough, Robitussin Long-Acting Cough Soft Chews, Robitussin Long-Acting Coughgels, Robocough, Robohbr Cough Suppressant, Robotablets, Signature Care 12 Hour Cough Relief, Signature Care Childrens 12 Hour Cough Relief, Signature Care Cough Relief, Stona, Topcare Cough Dm, Up And Up 12 Hour Cough Relief, Valumeds Cough Relief, Dextromethorphan Hbr, Vicks Formula 44dm Cough
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3289
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018658 | RECKITT BENCKISER | 1982-10-08 | 5 |
| ANDA 091135 | TRIS PHARMA INC | 2012-05-25 | 57 |
| ANDA 203133 | AMNEAL | 2017-07-28 | 2 |
| ANDA 218417 | AUROBINDO PHARMA LTD | 2026-04-15 | 4 |
Official labeling on DailyMed
- 12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] · version 3 · 2026-09-24
- DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] · version 15 · 2026-09-11
- DRX CHOICE LONG ACTING COUGH (DEXTROMETHORPHAN HBR) LIQUID [RARITAN PHARMACEUTICALS] · version 4 · 2026-09-10
- DEXTROMETHORPHAN HBR CAPSULE, LIQUID FILLED [BIONPHARMA INC.] · version 1 · 2026-09-02
- GOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY] · version 5 · 2026-08-31
- COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-21
- CVS LONG ACTING COUGH (DEXTROMETHORPHAN HBR) LIQUID [CVS PHARMACY, INC] · version 7 · 2026-08-20
- COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-20
- ADULT LONG LASTING COUGH RELIEF (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [SHIELD PHARMACEUTICALS CORP] · version 2 · 2026-08-10
- MUCINEX INSTASOOTHE COUGH (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC] · version 5 · 2026-08-05
- ROBITUSSIN DIRECT COUGH (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] · version 4 · 2026-08-03
- ROBITUSSIN LONG-ACTING COUGHGELS (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] · version 5 · 2026-08-03
Showing the 12 most recent of 122 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.