Home NDC 58552-334 Giltuss Allergy Plus
Product NDC 58552-334
11-digit product format 585520334
Labeler code 58552
Product ID 58552-334_5746a65e-86da-77cd-e063-6394a90aefc7
Type HUMAN OTC DRUG
Nonproprietary name Chlophedianol HCl, Chlorpheniramine maleate, 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 2027-06-30
Substance PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE
Active strength 10; 3.5; 24 mg/1; 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
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 Allergy Plus Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 CHLORPHENIRAMINE MALEATE 3.5 mg/1 CHLOPHEDIANOL HYDROCHLORIDE 24 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 69QQ58998Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1424872 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 58552-334-20 Giltuss Allergy Plus 10 in 1 BOX TABLET 10 7 58552-334-20 Giltuss Allergy Plus 2 in 1 POUCH TABLET 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-334 GILTUSS ALLERGY PLUS (CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 6 Current NDC, Legacy NDC, 2 package rows 20250315_85a0dc7f-ffb5-7d52-e053-2991aa0a602a.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 58552-334-20 58552033420 10 POUCH in 1 BOX (58552-334-20) / 2 TABLET in 1 POUCH 10 pouch 2021-04-01 2027-06-30 No No Current