Home NDC 83324-215 QUALITY CHOICE
Product NDC 83324-215
11-digit product format 833240215
Labeler code 83324
Product ID 83324-215_13ea592d-c08e-49bf-a433-b5ae2b8f27db
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form SOLUTION/ DROPS
Route NASAL
Labeler CHAIN DRUG MARKETING ASSOCIATION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-08
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 1 g/100mL
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 QUALITY CHOICE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-215-01 QUALITY CHOICE 1 in 1 CARTON SOLUTION/ DROPS 1 2 83324-215-01 QUALITY CHOICE 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-215 QUALITY CHOICE (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION] 1 Current NDC, 2 package rows 20241010_14596551-dd82-46b3-8eb8-e69efaea105b.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 177 · 3,534 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83324-215-01 83324021501 1 BOTTLE, DROPPER in 1 CARTON (83324-215-01) / 30 mL in 1 BOTTLE, DROPPER 2024-10-08 No No Current