Poly-Vent IR
- Product NDC
- 50991-212
- 11-digit product format
- 509910212
- Labeler code
- 50991
- Product ID
- 50991-212_26838be8-5a59-bb4d-e063-6394a90affe9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-06-11
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 380; 60 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 IR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 380 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1426579 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-212-01 | Poly-Vent IR | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 50991-212-02 | Poly-Vent IR | 12 in 1 BLISTER PACK | TABLET | 12 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-212 | POLY-VENT IR (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241111_ce0d8c45-446a-4df4-a36b-5000ba69d30d.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 |
|---|
| 50991-212-01 | 50991021201 | 100 TABLET in 1 BOTTLE (50991-212-01) | 100 tablet | 2013-06-11 | 0000-00-00 | No | No | Current |
| 50991-212-02 | 50991021202 | 12 TABLET in 1 BLISTER PACK (50991-212-02) | 12 tablet | 2013-06-11 | 0000-00-00 | No | No | Current |