Home NDC 58552-331 Giltuss Cough and Cold
Product NDC 58552-331
11-digit product format 585520331
Labeler code 58552
Product ID 58552-331_5746a790-450c-79d7-e063-6394a90a7077
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, 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 2027-01-30
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 388; 28; 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 Cough and Cold Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 388 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 28 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH 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 2167784 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 58552-331-20 Giltuss Cough and Cold 2 in 1 CARTON TABLET 2 7 58552-331-20 Giltuss Cough and Cold 10 in 1 BLISTER PACK TABLET 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-331 GILTUSS COUGH AND COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 6 Current NDC, Legacy NDC, 2 package rows 20250315_8590fcc9-c0dd-f43b-e053-2991aa0a692e.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 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 Marketing end Sample Exclude flag Status 58552-331-20 58552033120 2 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2021-04-01 2027-01-30 No No Current