Poly-Vent DM
- Product NDC
- 50991-214
- 11-digit product format
- 509910214
- Labeler code
- 50991
- Product ID
- 50991-214_46518b53-5ca9-c68b-e063-6394a90a4150
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-06-17
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 20; 380; 60 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Poly-Vent DM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 380 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1427998 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-214-01 | Poly-Vent DM | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 50991-214-02 | Poly-Vent DM | 12 in 1 CARTON | TABLET | 12 | | 12 |
| 50991-214-02 | Poly-Vent DM | 1 in 1 POUCH | TABLET | 1 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-214 | POLY-VENT DM (DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241109_739329ae-0b62-4eab-a07d-867b5d3d61e0.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 |
|---|
| 50991-214-01 | 50991021401 | 100 TABLET in 1 BOTTLE (50991-214-01) | 100 tablet | 2013-06-17 | 0000-00-00 | No | No | Current |
| 50991-214-02 | 50991021402 | 12 POUCH in 1 CARTON (50991-214-02) / 1 TABLET in 1 POUCH | 12 pouch | 2013-06-17 | 0000-00-00 | No | No | Current |