Poly-Hist DM
- Product NDC
- 50991-220
- 11-digit product format
- 509910220
- Labeler code
- 50991
- Product ID
- 50991-220_efbbc735-8a94-7984-e053-2995a90a3eb8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2013-06-22
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| THONZYLAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6K9YKD48Y4 | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| THONZYLAMINE | ACTIVE MOIETY | R79646H5Z8 | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| AMMONIUM GLYCYRRHIZATE | INACTIVE INGREDIENT | 3VRD35U26C | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| POTASSIUM CITRATE | INACTIVE INGREDIENT | EE90ONI6FF | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-220 | POLY-HIST DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL AND THONZYLAMINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.] | 10 | Legacy NDC | 20240711_d1c74d4c-71bb-4934-9a4e-556366c07fca.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50991-220-15 | 50991022015 | 6 BOTTLE in 1 TRAY (50991-220-15) > 15 mL in 1 BOTTLE | 6 bottle | 2013-06-22 | 0000-00-00 | No | No | Current |
| 50991-220-16 | 50991022016 | 473 mL in 1 BOTTLE (50991-220-16) | 473 ml | 2013-06-22 | 0000-00-00 | No | No | Current |