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NDC 50991-0132-15 Polytussin DM 7.5; 5; 12.5 mg/5mL; mg/5mL; mg/5mL Details
Polytussin DM 7.5; 5; 12.5 mg/5mL; mg/5mL; mg/5mL
Polytussin DM is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE.
Product Information
| NDC | 50991-0132 |
|---|---|
| Product ID | 50991-132_fda90ac0-7479-4cd6-e053-6294a90abbf0 |
| Associated GPIs | |
| GCN Sequence Number | 085040 |
| GCN Sequence Number Description | pyrilamine/phenylephrine/DM LIQUID 12.5-5MG/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 54479 |
| HICL Sequence Number | 035673 |
| HICL Sequence Number Description | PYRILAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | Polytussin DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 7.5; 5; 12.5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE |
| 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 50991-0132-15 (50991013215)
| NDC Package Code | 50991-132-15 |
|---|---|
| Billing NDC | 50991013215 |
| Package | 15 mL in 1 BOTTLE (50991-132-15) |
| Marketing Start Date | 2023-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |