POLY-HIST DM
- Product NDC
- 50991-271
- 11-digit product format
- 509910271
- Labeler code
- 50991
- Product ID
- 50991-271_5025c99f-b947-e2e0-e063-6394a90a13fb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- POLY PHARMACEUTICALS, INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-23
- Substance
- DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 1; 10 mg/5mL; 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
- POLY-HIST DM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXCHLORPHENIRAMINE MALEATE | 1 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B10YD955QW, 9D2RTI9KYH |
| Rxcui | 2741371 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-271-15 | POLY-HIST DM | 15 mL in 1 BOTTLE | LIQUID | 15 | | 1 |
| 50991-271-16 | POLY-HIST DM | 473 mL in 1 BOTTLE | LIQUID | 473 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50991-271-15 | 50991027115 | 15 mL in 1 BOTTLE (50991-271-15) | 15 ml | 2026-04-23 | No | No | Historical |
| 50991-271-16 | 50991027116 | 473 mL in 1 BOTTLE (50991-271-16) | 473 ml | 2026-04-23 | No | No | Historical |