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NDC 50991-0220-16 Poly-Hist DM 10; 5; 25 mg/5mL; mg/5mL; mg/5mL Details
Poly-Hist DM 10; 5; 25 mg/5mL; mg/5mL; mg/5mL
Poly-Hist DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE.
Product Information
| NDC | 50991-0220 |
|---|---|
| Product ID | 50991-220_f4c8925c-ac50-43b1-e053-2995a90a916c |
| Associated GPIs | 43995803950930 |
| GCN Sequence Number | 071147 |
| GCN Sequence Number Description | thonzylamine/phenylephrine/DM LIQUID 25-5-10/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 34835 |
| HICL Sequence Number | 040444 |
| HICL Sequence Number Description | THONZYLAMINE HCL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | Poly-Hist DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 5; 25 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE |
| Labeler Name | Poly Pharmaceuticals, Inc. |
| Pharmaceutical Class | 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] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50991-0220-16 (50991022016)
| NDC Package Code | 50991-220-16 |
|---|---|
| Billing NDC | 50991022016 |
| Package | 473 mL in 1 BOTTLE (50991-220-16) |
| Marketing Start Date | 2013-06-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |