Home NDC 58552-147 Giltuss D
Product NDC 58552-147
11-digit product format 585520147
Labeler code 58552
Product ID 58552-147_4aa0fa30-61e2-bdb5-e063-6394a90afffd
Type HUMAN OTC DRUG
Nonproprietary name Giltuss D
Dosage form SYRUP
Route ORAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-11
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 3.5; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
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 D
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 3.5 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 V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII 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 58552-147-04 Giltuss D 1 in 1 CARTON SYRUP 1 4 58552-147-04 Giltuss D 1 in 1 BOTTLE SYRUP 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-147 GILTUSS D SYRUP [GIL PHARMACEUTICAL CORP] 2 Current NDC, 2 package rows 20241027_298f5457-a7df-474d-9854-68918ee3d330.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58552-147-04 58552014704 1 BOTTLE in 1 CARTON (58552-147-04) / 1 SYRUP in 1 BOTTLE 1 bottle 2024-04-11 No No Current