giltuss allergy plus cough and congestion

Generic: chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name giltuss allergy plus cough and congestion
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler gil pharmaceutical corp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 4 mg/10mL, dextromethorphan hydrobromide 20 mg/10mL, phenylephrine hydrochloride 10 mg/10mL

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-138
Product ID 58552-138_40b8aa4b-9a36-7312-e063-6394a90a7952
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-10-02

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 58552138
Hyphenated Format 58552-138

Supplemental Identifiers

RxCUI
1363752
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 giltuss allergy plus cough and congestion (source: ndc)
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/10mL
  • 20 mg/10mL
  • 10 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58552-138-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

58552-138-04 1 BOTTLE in 1 CARTON (58552-138-04) / 118 mL in 1 BOTTLE

Ingredients (3)

chlorpheniramine maleate (4 mg/10mL) dextromethorphan hydrobromide (20 mg/10mL) phenylephrine hydrochloride (10 mg/10mL)

Linked Drug Pages (1)

Giltuss Allergy Plus Cough and Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b8aa4b-9a36-7312-e063-6394a90a7952", "openfda": {"unii": ["V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1363752"], "spl_set_id": ["85065cf3-386d-22d5-e053-2a91aa0a72da"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58552-138-04)  / 118 mL in 1 BOTTLE", "package_ndc": "58552-138-04", "marketing_start_date": "20181002"}], "brand_name": "Giltuss Allergy Plus Cough and Congestion", "product_id": "58552-138_40b8aa4b-9a36-7312-e063-6394a90a7952", "dosage_form": "SOLUTION", "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": "58552-138", "generic_name": "CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Allergy Plus", "brand_name_suffix": "Cough and Congestion", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181002", "listing_expiration_date": "20261231"}