giltuss cough and cold

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name giltuss cough and cold
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler gil pharmaceutical corp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 28 mg/1, guaifenesin 388 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-331
Product ID 58552-331_40b98a8e-7695-b8d6-e063-6294a90af8ea
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58552331
Hyphenated Format 58552-331

Supplemental Identifiers

RxCUI
2167784
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 cough and cold (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 28 mg/1
  • 388 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

58552-331-20 2 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK

Ingredients (3)

dextromethorphan hydrobromide (28 mg/1) guaifenesin (388 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Giltuss Cough and Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b98a8e-7695-b8d6-e063-6294a90af8ea", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["2167784"], "spl_set_id": ["8590fcc9-c0dd-f43b-e053-2991aa0a692e"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "2 BLISTER PACK in 1 CARTON (58552-331-20)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58552-331-20", "marketing_start_date": "20210401"}], "brand_name": "Giltuss Cough and Cold", "product_id": "58552-331_40b98a8e-7695-b8d6-e063-6294a90af8ea", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "58552-331", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Cough and Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "28 mg/1"}, {"name": "GUAIFENESIN", "strength": "388 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}