Home NDC 0225-0811 Neo-Synephrine Severe
Product NDC 0225-0811
11-digit product format 002250811
Labeler code 0225
Product ID 0225-0811_54edb0ef-b9fc-8470-e063-6394a90a5885
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 2026-06-01
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 Neo-Synephrine Severe
Listing expiration 2027-12-31 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1087043 Internal RxNorm lookup 1234569 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 98 of 178 · 3,551 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0225-0811-47 00225081147 15 mL in 1 BOTTLE, SPRAY (0225-0811-47) 15 ml 2026-06-01 No No Current