giltuss ex expectorant

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name giltuss ex expectorant
Generic Name guaifenesin
Labeler gil pharmaceutical corp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/10mL

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-145
Product ID 58552-145_40b8ef34-8eeb-c72d-e063-6294a90aff26
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-06-22

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 58552145
Hyphenated Format 58552-145

Supplemental Identifiers

RxCUI
310625
UNII
495W7451VQ
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 ex expectorant (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58552-145-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

58552-145-04 1 BOTTLE in 1 CARTON (58552-145-04) / 118 mL in 1 BOTTLE

Ingredients (1)

guaifenesin (400 mg/10mL)

Linked Drug Pages (1)

Giltuss EX Expectorant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b8ef34-8eeb-c72d-e063-6294a90aff26", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310625"], "spl_set_id": ["a8c53c14-ba82-2c68-e053-2a95a90a9894"], "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": "1 BOTTLE in 1 CARTON (58552-145-04)  / 118 mL in 1 BOTTLE", "package_ndc": "58552-145-04", "marketing_start_date": "20200622"}], "brand_name": "Giltuss EX Expectorant", "product_id": "58552-145_40b8ef34-8eeb-c72d-e063-6294a90aff26", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "58552-145", "generic_name": "Guaifenesin", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss EX Expectorant", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200622", "listing_expiration_date": "20261231"}