Cough DM
- Product NDC
- 51316-431
- 11-digit product format
- 513160431
- Labeler code
- 51316
- Product ID
- 51316-431_648bf8f2-b264-4223-9793-523fe04b6754
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Doxylamine Succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-25
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 30; 12.5 mg/20mL; mg/20mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cough DM
- Brand name suffix
- Nighttime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/20mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/20mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1115329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-431-36 | Cough DMNighttime | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 2 | |
| 51316-431-36 | Cough DMNighttime | 1 in 1 CARTON | SOLUTION | 1 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2056073 | {1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack | GPCK | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 2056073 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) Pack | PSN | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution | PSN | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution | PSN | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution | SCD | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution | SCD | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2 |
| 2056073 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) Pack | SY | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution | SY | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution | SY | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2 |
| 1115329 | dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution | SY | 184059b7-9238-480e-be4a-ed105f13c19d | 2 |
| 1115329 | dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution | SY | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 51316-431-36 | 51316043136 | 1 BOTTLE, PLASTIC in 1 CARTON (51316-431-36) / 118 mL in 1 BOTTLE, PLASTIC | 2026-02-25 | No | No | Current |