giltuss sinus and chest congestion

Generic: guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name giltuss sinus and chest congestion
Generic Name guaifenesin, phenylephrine hcl
Labeler gil pharmaceutical corp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 388 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-332
Product ID 58552-332_40b98fe6-b671-7255-e063-6294a90a0d73
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 58552332
Hyphenated Format 58552-332

Supplemental Identifiers

RxCUI
1946782
UNII
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 sinus and chest congestion (source: ndc)
Generic Name guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 388 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (58552-332-20) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

58552-332-20 2 BLISTER PACK in 1 CARTON (58552-332-20) / 10 TABLET in 1 BLISTER PACK

Ingredients (2)

guaifenesin (388 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Giltuss Sinus and Chest Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b98fe6-b671-7255-e063-6294a90a0d73", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["1946782"], "spl_set_id": ["8591003c-c2f2-df65-e053-2a91aa0a42fb"], "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": false, "description": "2 BLISTER PACK in 1 CARTON (58552-332-20)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58552-332-20", "marketing_start_date": "20210401"}], "brand_name": "Giltuss Sinus and Chest Congestion", "product_id": "58552-332_40b98fe6-b671-7255-e063-6294a90a0d73", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "58552-332", "generic_name": "Guaifenesin, Phenylephrine HCl", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Sinus and Chest Congestion", "active_ingredients": [{"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"}