Home NDC 84324-010 Nasal Decongestant PE
Product NDC 84324-010
11-digit product format 843240010
Labeler code 84324
Product ID 84324-010_5869b99d-5cbb-41a1-a32a-82afd167d30e
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl 10 mg
Dosage form TABLET
Route ORAL
Labeler NUVICARE LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-17
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [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 Nasal Decongestant PE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1049182 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 84324-010-01 Nasal Decongestant PE 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84324-010 NASAL DECONGESTANT PE (PHENYLEPHRINE HCL 10 MG) TABLET [NUVICARE LLC] 1 Current NDC, 1 package rows 20240718_4cde41dd-a0a7-45e7-aff3-ee9402dfdff2.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 Sample Exclude flag Status 84324-010-01 84324001001 100 TABLET in 1 BOTTLE (84324-010-01) 100 tablet 2024-07-17 No No Current