Home NDC 0363-4534 Sinus PE Congestion
Product NDC 0363-4534
11-digit product format 003634534
Labeler code 0363
Product ID 0363-4534_04dde71c-38ba-4412-b583-097958bf2d19
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Phenylephrine HCl
Dosage form KIT
Labeler Walgreen Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-19
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 Sinus PE Congestion
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049182 Internal RxNorm lookup 1052928 Internal RxNorm lookup 2639176 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 0363-4534-09 Sinus PE Congestion 1 in 1 PACKAGE, COMBINATION KIT 1 9 0363-7453-42 Sinus PE Congestion 12 in 1 BLISTER PACK TABLET, FILM COATED 12 10 mg 9 0363-7485-40 Sinus PE Congestion 8 in 1 BLISTER PACK TABLET, FILM COATED 8 25 mg 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-4534 SINUS PE CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY] 8 Current NDC, Legacy NDC, 3 package rows 20250130_5b9151b7-3e40-4f37-b3e0-4c0fa0115b71.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 0363-4534-09 00363453409 1 KIT in 1 PACKAGE, COMBINATION (0363-4534-09) * 12 TABLET, FILM COATED in 1 BLISTER PACK (0363-7453-42) * 8 TABLET, FILM COATED in 1 BLISTER PACK (0363-7485-40) 1 kit 2022-01-19 0000-00-00 No No Current 0363-7453-42 00363745342 12 in 1 BLISTER PACK Historical 0363-7485-40 00363748540 8 in 1 BLISTER PACK Historical