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NDC 28595-0804-16 HISTEX-DM 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL Details
HISTEX-DM 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL
HISTEX-DM is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Allegis Pharmaceuticals, LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
| NDC | 28595-0804 |
|---|---|
| Product ID | 28595-804_0e764fe3-cd4a-71c8-e063-6394a90afa31 |
| Associated GPIs | 43995803961220 |
| GCN Sequence Number | 072192 |
| GCN Sequence Number Description | triprolidine/phenylephrine/DM LIQUID 2.5-10-20 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 36311 |
| HICL Sequence Number | 041030 |
| HICL Sequence Number Description | TRIPROLIDINE HCL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | HISTEX-DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 20; 10; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
| Labeler Name | Allegis Pharmaceuticals, LLC |
| 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 DRUG |
| Application Number | M012 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 28595-0804-16 (28595080416)
| NDC Package Code | 28595-804-16 |
|---|---|
| Billing NDC | 28595080416 |
| Package | 473 mL in 1 BOTTLE (28595-804-16) |
| Marketing Start Date | 2014-03-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |