Home NDC 83586-010 PHENYLEPHRINE HYDROCHLORIDE
Product NDC 83586-010
11-digit product format 835860010
Labeler code 83586
Product ID 83586-010_511f5bae-76c1-065a-e063-6294a90a6260
Type HUMAN OTC DRUG
Nonproprietary name PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler HHH Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-10
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 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 PHENYLEPHRINE HYDROCHLORIDE
Listing expiration 2027-12-31 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 83586-010-00 PHENYLEPHRINE HYDROCHLORIDE 130000 in 1 DRUM TABLET 130000 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83586-010-00 83586001000 130000 TABLET in 1 DRUM (83586-010-00) 130000 tablet 2025-09-10 No No Current