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NDC 58552-0337-02 PHENAGIL 3.5; 29; 10 mg/1; mg/1; mg/1 Details
PHENAGIL 3.5; 29; 10 mg/1; mg/1; mg/1
PHENAGIL is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Gil Pharmaceutical Corp.. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 58552-0337 |
|---|---|
| Product ID | 58552-337_0875cad9-99b4-4d4f-e063-6394a90a3bbc |
| Associated GPIs | |
| GCN Sequence Number | 085438 |
| GCN Sequence Number Description | chlorpheniramine/phenyleph/DM TABLET 3.5-10-29 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 54919 |
| HICL Sequence Number | 000375 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Brand |
| Proprietary Name | PHENAGIL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 3.5; 29; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Gil Pharmaceutical Corp. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58552-0337-02 (58552033702)
| NDC Package Code | 58552-337-02 |
|---|---|
| Billing NDC | 58552033702 |
| Package | 2 TABLET in 1 BLISTER PACK (58552-337-02) |
| Marketing Start Date | 2022-05-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |