Home NDC 58552-142 Giltuss Severe Sinus
Product NDC 58552-142
11-digit product format 585520142
Labeler code 58552
Product ID 58552-142_40b8f0e4-90a0-f6b2-e063-6394a90a083b
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline HCl
Dosage form SPRAY
Route NASAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-28
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .05 g/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Severe Sinus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K89MJ0S5VY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000990 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-142-15 Giltuss Severe Sinus 1 in 1 CARTON SPRAY 1 6 58552-142-15 Giltuss Severe Sinus 15 mL in 1 BOTTLE, SPRAY SPRAY 15 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-142 GILTUSS SEVERE SINUS (OXYMETAZOLINE HCL) SPRAY [GIL PHARMACEUTICAL CORP] 5 Current NDC, Legacy NDC, 2 package rows 20241027_ab7fae3b-1f7d-5d0f-e053-2a95a90a148e.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 98 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58552-142-15 58552014215 1 BOTTLE, SPRAY in 1 CARTON (58552-142-15) / 15 mL in 1 BOTTLE, SPRAY 2020-07-28 0000-00-00 No No Current