Home NDC 64336-170 Vicks Sinex Severe
Product NDC 64336-170
11-digit product format 643360170
Labeler code 64336
Product ID 64336-170_500f54a4-3615-924d-e063-6294a90af20f
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline Hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Procter & Gamble Manufacturing GmbH
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-20
Marketing end 2028-02-28
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .0005095 g/mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
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 Vicks Sinex Severe
Brand name suffix Original Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .0005095 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K89MJ0S5VY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000990 Internal RxNorm lookup 1001066 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 64336-170-01 Vicks Sinex SevereOriginal 15 mL in 1 BOTTLE, SPRAY SPRAY 15 8 64336-170-01 Vicks Sinex SevereOriginal 1 in 1 CARTON SPRAY 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64336-170 VICKS SINEX SEVERE ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PROCTER & GAMBLE MANUFACTURING GMBH] 5 Current NDC, Legacy NDC, 2 package rows 20241012_cfd048c9-2f33-101d-e053-2995a90ad854.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64336-170-01 64336017001 1 BOTTLE, SPRAY in 1 CARTON (64336-170-01) / 15 mL in 1 BOTTLE, SPRAY 2018-12-20 2028-02-28 No No Current