phenagil

Generic: chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl

Labeler: gil pharmaceutical corp.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name phenagil
Generic Name chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl
Labeler gil pharmaceutical corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 3.5 mg/1, dextromethorphan hydrobromide 29 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Gil Pharmaceutical Corp.

Identifiers & Regulatory

Product NDC 58552-337
Product ID 58552-337_40babb39-ba9f-f7b6-e063-6394a90a3ab6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-05-26

Pharmacologic Class

Classes
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 receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58552337
Hyphenated Format 58552-337

Supplemental Identifiers

RxCUI
2603661
UNII
V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name phenagil (source: ndc)
Generic Name chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1
  • 29 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (58552-337-01)
  • 2 TABLET in 1 BLISTER PACK (58552-337-02)
source: ndc

Packages (2)

58552-337-01 100 TABLET in 1 BOTTLE (58552-337-01) 58552-337-02 2 TABLET in 1 BLISTER PACK (58552-337-02)

Ingredients (3)

chlorpheniramine maleate (3.5 mg/1) dextromethorphan hydrobromide (29 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

PHENAGIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40babb39-ba9f-f7b6-e063-6394a90a3ab6", "openfda": {"unii": ["V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["2603661"], "spl_set_id": ["a6880389-0dc1-43a7-a73b-77f77bafe51e"], "manufacturer_name": ["Gil Pharmaceutical Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (58552-337-01)", "package_ndc": "58552-337-01", "marketing_start_date": "20220526"}, {"sample": true, "description": "2 TABLET in 1 BLISTER PACK (58552-337-02)", "package_ndc": "58552-337-02", "marketing_start_date": "20220526"}], "brand_name": "PHENAGIL", "product_id": "58552-337_40babb39-ba9f-f7b6-e063-6394a90a3ab6", "dosage_form": "TABLET", "pharm_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 Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "58552-337", "generic_name": "Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL", "labeler_name": "Gil Pharmaceutical Corp.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PHENAGIL", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "3.5 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "29 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220526", "listing_expiration_date": "20261231"}