Home NDC 0225-0805 Neo-Synephrine Regular
Product NDC 0225-0805
11-digit product format 002250805
Labeler code 0225
Product ID 0225-0805_0a4959f4-48c2-1fab-e063-6394a90a41f8
Type HUMAN OTC DRUG
Nonproprietary name PHENYLEPHRINE HYDROCHLORIDE
Dosage form SPRAY
Route NASAL
Labeler BF ASCHER AND CO INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-01
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength .5 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 Neo-Synephrine Regular
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE .5 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234584 Internal RxNorm lookup 1234585 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 0225-0805-47 Neo-Synephrine Regular 15 mL in 1 BOTTLE, SPRAY SPRAY 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0225-0805 NEO-SYNEPHRINE REGULAR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [BF ASCHER AND CO INC] 2 Current NDC, Legacy NDC, 1 package rows 20231117_ab860c10-b8cf-3f92-e053-2a95a90a7317.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 0225-0805-47 00225080547 15 mL in 1 BOTTLE, SPRAY (0225-0805-47) 15 ml 2020-07-01 0000-00-00 No No Current