Home NDC 63868-697 Quality Choice
Product NDC 63868-697
11-digit product format 638680697
Labeler code 63868
Product ID 63868-697_451d9a35-c00a-401d-e063-6294a90ac45a
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 2018-12-18
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 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 Quality Choice
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL
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 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 63868-697-30 Quality Choice 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 6 63868-697-30 Quality Choice 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-697 QUALITY CHOICE (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION] 5 Current NDC, Legacy NDC, 2 package rows 20241222_a12e2e66-d2f3-47a6-a915-a309ae828d27.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 74 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-697-30 63868069730 1 BOTTLE, DROPPER in 1 CARTON (63868-697-30) / 30 mL in 1 BOTTLE, DROPPER 2018-12-18 0000-00-00 No No Current