Home NDC 58552-332 Giltuss Sinus and Chest Congestion
Product NDC 58552-332
11-digit product format 585520332
Labeler code 58552
Product ID 58552-332_5746ab21-fd63-7ac4-e063-6394a90aa199
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-01
Marketing end 2027-02-28
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 388; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 Sinus and Chest Congestion Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 388 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1946782 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 58552-332-20 Giltuss Sinus and Chest Congestion 2 in 1 CARTON TABLET 2 8 58552-332-20 Giltuss Sinus and Chest Congestion 10 in 1 BLISTER PACK TABLET 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-332 GILTUSS SINUS AND CHEST CONGESTION (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 7 Current NDC, Legacy NDC, 2 package rows 20250315_8591003c-c2f2-df65-e053-2a91aa0a42fb.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 73 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 58552-332-20 58552033220 2 BLISTER PACK in 1 CARTON (58552-332-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2021-04-01 2027-02-28 No No Current