cough dm
- Product NDC
- 0904-6312
- 11-digit product format
- 009046312
- Labeler code
- 0904
- Product ID
- 0904-6312_0eeb9b8e-c4e1-4030-83b1-19240269851f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA091135
- Marketing category
- ANDA
- Marketing start
- 2012-09-06
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 30 mg/5mL
- Pharmacologic classes
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH |
| Rxcui | 1373045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6312-56 | cough dm | 89 mL in 1 BOTTLE | SUSPENSION | 89 | | 5 |
| 0904-6312-56 | cough dm | 1 in 1 CARTON | SUSPENSION | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6312 | COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20200820_cdb5616e-0f04-4b9e-a82b-994e9ba3b515.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6312-56 | 00904631256 | 1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE | 1 bottle | 2012-09-06 | 0000-00-00 | No | No | Current |