Home NDC 58552-145 Giltuss EX Expectorant
Product NDC 58552-145
11-digit product format 585520145
Labeler code 58552
Product ID 58552-145_40b8ef34-8eeb-c72d-e063-6294a90aff26
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-22
Substance GUAIFENESIN
Active strength 400 mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Giltuss EX Expectorant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310625 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-145-04 Giltuss EX Expectorant 118 mL in 1 BOTTLE SOLUTION 118 6 58552-145-04 Giltuss EX Expectorant 1 in 1 CARTON SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-145 GILTUSS EX EXPECTORANT (GUAIFENESIN) SOLUTION [GIL PHARMACEUTICAL CORP] 5 Current NDC, Legacy NDC, 2 package rows 20241027_a8c53c14-ba82-2c68-e053-2a95a90a9894.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58552-145-04 58552014504 1 BOTTLE in 1 CARTON (58552-145-04) / 118 mL in 1 BOTTLE 1 bottle 2020-06-22 0000-00-00 No No Current