Home NDC 58552-341 Giltuss EX Maximum Strength Expectorant
Product NDC 58552-341
11-digit product format 585520341
Labeler code 58552
Product ID 58552-341_51b2b733-3d3b-762d-e063-6294a90a41a5
Type HUMAN OTC DRUG
Nonproprietary name Giltuss EX Maximum Strength Expectorant
Dosage form TABLET
Route ORAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-07
Substance GUAIFENESIN
Active strength 1200 mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Maximum Strength Expectorant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 1200 mg/1
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 310621 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-341-07 Giltuss EX Maximum Strength Expectorant 1 in 1 CARTON TABLET 1 2 58552-341-07 Giltuss EX Maximum Strength Expectorant 7 in 1 BLISTER PACK TABLET 7 2 58552-341-14 Giltuss EX Maximum Strength Expectorant 1 in 1 CARTON TABLET 1 2 58552-341-14 Giltuss EX Maximum Strength Expectorant 14 in 1 BOTTLE TABLET 14 2
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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58552-341-07 58552034107 1 BLISTER PACK in 1 CARTON (58552-341-07) / 7 TABLET in 1 BLISTER PACK 1 blister pack 2025-10-07 Yes No Current 58552-341-14 58552034114 1 BOTTLE in 1 CARTON (58552-341-14) / 14 TABLET in 1 BOTTLE 1 bottle 2025-10-07 No No Current